Inflammatory Bowel Disease Flare Research Articles

P776 Hospital re-admission in patients with inflammatory bowel disease: what are the risk factors?

Abstract Background Early re-admission after hospitalisation for an inflammatory bowel disease (IBD) flare is a negative quality indicator and causes unnecessary healthcare expense. Scoring systems to predict IBD readmissions have been shown to be ineffective. We aimed to describe the IBD re-admission rate at our hospital and investigate the risk factors. Methods Retrospective study of patients admitted to a London-based district general hospital under the gastroenterology team with a flare of inflammatory bowel disease between 2015 and 2018. Characteristic including but not limited to demographics, disease type, length of stay (LOS) during index admission, biochemistry and biologic use were recorded. Hospital software (Sunquest Integrated Clinical Environment, Medway) was used to identify patients re-admitted at 30 and 90 days after discharge. Multivariate logistic regression was performed. Results One hundred and thirty-eight patients were admitted with an IBD flare during the study period (74 (53.6%) Crohn’s disease (CD), 56 (40.6%) ulcerative colitis (UC), 8 (5.8%) IBD-U). Median age 33.5 (IQR 26–52), 71 (51.4%) female. Median LOS was 4.5 days (IQR 1.8–8). 36 (26%) patients were taking a biologic. Re-admissions occurred within 30 days in 19 patients (13.7%) and within 90 days in 30 patients (21.7%). Multivariate logistic regression showed that a raised CRP on discharge was associated with re-admission. For every increased unit of CRP by one there was an increased risk of readmission by 1.1 times (p = 0.05). Patients aged 22–39 were significantly less likely to be readmitted (OR: 0.38, p = 0.015). Male patients were significantly more likely to be readmitted (OR: 2.52, p = 0.05). Conclusion The 30 days and 90 days re-admission rate for our IBD population is just over 10% and 20%, respectively. CRP at discharge is significantly associated with both 30 and 90 days re-admission. After adjusting for confounders; CRP, age older than 40 and male gender were associated with re-admission to hospital. We advise caution in discharging IBD patients with raised inflammatory markers. Close follow-up within a few days of discharge would be appropriate in this high-risk sub-group.

P832 Gastrointestinal infections are associated with unique gut microbiome signatures in patients with inflammatory bowel disease

Abstract Background Stool PCR pathogen panel assays have implicated enteric infection in nearly 30% of inflammatory bowel disease (IBD) flares, most commonly with Clostridioides difficile, Escherichia coli, and norovirus. Many questions remain about the interpretation of a positive stool PCR result, and the similar presentations of infection and flare present a clinical challenge. We aimed to characterise the gut microbiome during an infection with C. difficile, E. coli, or norovirus in patients with and without IBD to microbially differentiate patients with an enteric infection, flare of IBD, and flare of IBD complicated by a pathogen. Methods We performed a cross-sectional study of patients with a stool PCR panel positive for C. difficile, E. coli subtypes, norovirus, or negative for all pathogens during an episode of gastrointestinal symptoms from September 2018 to February 2019. Clinical data and remnant stool specimens were collected. Our primary outcome was microbiome signature using 16s bacterial rRNA gene sequencing derived from linear discriminant analysis effect size (LEfSe) to identify microbes associated with each pathogen and clinical scenario stratified by IBD. Results We identified 119 patients, 19 (16%) with IBD, with C. difficile (n = 30), an E. coli subtype (n = 30), norovirus (n = 29), or negative for all pathogens (n = 30; Table). Hematochezia on presentation and recent antibiotic or hospitalisation exposure was more common in pathogen negative patients compared with pathogen positive patients (p = 0.045, p = 0.007, respectively). Patients with IBD without a pathogen or with C. difficile tended to have higher serum biomarkers of inflammation (median CRP 24 and 28, respectively) compared with patients with an E. coli subtype (CRP 5) or norovirus (CRP 11). On LEfSe, patients with C. difficile were enriched in Enterobacteriaceae and Clostridioides, E. coli subtypes in Faecalibacterium, norovirus in Roseburia, and negative for a pathogen in Bacteroides. Stratifying by IBD and pathogen, there were several differentially abundant microbes denoting a specific gut microbial signature associated with each pathogen and IBD (Figure). Conclusion In this study of patients with C. difficile, E. coli, norovirus, or negative for pathogens during an episode of gastrointestinal symptoms, there were major differences in presentation and gut microbiota between patients with and without an enteric pathogen and IBD. These data demonstrate that gut microbiomes distinguish and differentially respond to pathogens. In patients with IBD, coupled with a unique microbiota, serum biomarkers of inflammation were lower in patients with E. coli or norovirus, suggesting a milder subset of IBD flare.

P355 Acceptability of treatment regimen in inflammatory bowel disease: Results from a prospective nationwide study (ACCEPT2)

Abstract Background The multiplication of therapeutic options with close efficacy and safety, leads to consider acceptability of treatment regimen as a key point for therapeutic decision in inflammatory bowel disease (IBD). We aimed to compare acceptability of IBD treatment regimen and to identify its associated factors. Methods From a nationwide prospective study conducted in 24 public or private centres, IBD patients were consecutively included for 6 weeks. A dedicated questionnaire was developed, tested and validated for the study. It was administered to each included patient and his/her related physician. Acceptability was graded with an acceptability numerical scale (ANS) from 0 (absolutely not acceptable) to 10 (totally acceptable). Results Overall, 1850 patients were included (65.9% with Crohn’s disease (CD), mean age = 41.0 ± 14.7, 22.2% experiencing IBD flare at inclusion). The medications at inclusion were none in 9.0%, oral (PO) monotherapy in 17.3%, subcutaneous (SC) injections in 29.2% and intra-venous (IV) infusions in 44.5% of the patients. The ANS were 8.68 ± 2.52 for PO, 7.67 ± 2.94 for SC and 6.79 ± 3.31 for IV (p < 0.001 for each comparison). The patients reported PO, SC and IV as their first choice in 65.8%, 21.4% and 12.8%, respectively. The reasons for reduced acceptability were the need to come to the hospital (63.0%) for IV infusion, none for SC injections and the fear to forget to take pills (30.5%), the number of daily dose (28.4%) and daily medication as a reminder of disease every day (24.8%) for PO therapy. In multivariable analyses, the following factors were associated with a better acceptability of IV infusion (current IBD flare: p = 0.003 and current IV therapy for IBD: p < 0.001), SC injections (Private practice: p = 0.006 and current SC injections for IBD: p < 0.001) and PO medication (male gender: p = 0.018, higher studies level: p < 0,001 and current oral medication: p = 0.002). The mean ANS for all IBD treatment regimen were compared in the 1850 patients (Figure 1). No difference was observed between CD and UC. In biologics-naïve patients (n = 315), the treatment regimens were ranked in the following order: PO once daily (8.8 ± 2.2), SC/12 weeks (week) (7.9 ± 3.0), SC/8 week and PO twice daily (7.2 ± 3.2 et 6.9 ± 3.4; ns), SC/4 week (6.2 ± 3.4), SC/2 week et IV/8 week (5.1 ± 3.4 and 5.0 ± 3.5; ns)(p < 0.001 except if ns was mentioned). For the patients, the acceptable loss of efficacy to receive a more convenient medication was 5.2% (non-inferiority trial limit). Conclusion While PO administration was preferred by most of IBD patients, the acceptability of treatment regimen is highly impacted by the interval between two doses and the previous medications. Our data could be helpful to guide therapeutic decision in daily practice in IBD.

P852 Introduction of Entamoeba histolytica serology testing in the management of inflammatory bowel disease patients at University Hospitals of Leicester, UK

Abstract Background Amoebic colitis can mimic inflammatory bowel disease (IBD) in clinical presentation, endoscopic and (to some extent) histological findings. Four patients with amoebic colitis were misdiagnosed with IBD or an IBD flare at University Hospitals of Leicester (UHL), UK in 2018. This prompted a change in practise in our department and we began screening for Entamoeba histolytica in patients with newly-diagnosed IBD, a flare or those being considered for biologics. We analysed cases of possible amoebic colitis after this change by reviewing IBD patients with a positive E. histolytica immunofluorescence antibody test (IFAT). Methods We conducted a retrospective electronic and case note review of patients with IBD and positive amoeba IFAT serology >1:80 from April 2019 through September 2019. We collected information including Crohn’s disease (CD), ulcerative colitis (UC), IBD treatment, histological findings, travel history, stool E. histolytica DNA polymerase chain reaction (PCR) and amoebic serology including IFAT and Cellulose Acetate Precipitin test (CAP). The histology of endoscopic biopsies for 16 of the IFAT positive patients was reviewed specifically for amoebic trophozoites. Results During the study period we identified 26 IFAT positive patients, excluded 3 patients that were felt to be non-IBD; 23 were included in the study. The median age was 37.8 (range 16–86); 43.5% were male. Four had a diagnosis of UC; 19 had CD. 12 were new IBD presentations. Seven patients had a relevant travel history (Jamaica, Thailand, Turkey, Italy, Greece, and Spain). Four did not have a travel history. Travel history was unknown for 12. Three patients were on biologics, one on biologics and thiopurines. Five were on thiopurines, three on thiopurines and steroids. Four were on steroids only, four on 5-ASAs. Three were on no treatment. Two out of 16 patients reviewed had amoebic trophozoites on endoscopic biopsy, unfortunately stool PCR was not sent on these two patients. Stool E. histolytica DNA PCR, was sent for 19 patients and was negative in those cases. All 24 patients were negative for CAP. Conclusion While IFAT is helpful in detecting past exposure it is only 75% sensitive for amoebic colitis. Even if IFAT and CAP are combined it is difficult to differentiate amoebic colitis from IBD. It is not clear if these cases represent past infections, early infections that precipitated an IBD flare, early infections that arose in the setting of immunosuppression, or false positive IFATs. The risk of infection in the immunosuppressed patient is high and the consequences of misdiagnosis are significant therefore a comprehensive screening method is merited; this may encompass IFAT ± CAP, stool E. histolytica DNA PCR, and possibly histological review.

P211 Positivity of stool sampling for enteric pathogens during inflammatory bowel disease flares in paediatric patients and its impact on disease outcomes

Abstract Background Enteric infections due to Clostridium difficile toxin (CDT) is more common in patients with inflammatory bowel disease (IBD). We aimed to assess the frequency and outcomes of CDT and non-CDT enteric infections in symptomatic paediatric patients with IBD. Methods Patients’ records were retrospectively searched for disease flares in which stool samples were collected. Each patient with a positive sample was matched with a patient with IBD flares and negative sample in order to analyse 1-year outcomes following sampling. Results A total of 618 paediatric patients with IBD (Crohn’s disease, n = 439, 71%, mean age at diagnosis 12.99 ± 3.4, females, n = 264, 42.7%) had 1204 stool samples during the study period (2001–2018). Of these, 43 (3.6%) were positive for bacteria, and 32 (74.4%) of which positive for Campylobacter jejuni. Of 463 samples for CDT, 31 (6.7%) were positive while parasitic infection was rare, 11/765 (1.4%). Overall, 19 positive C. jejuni cases and 19 positive CDT cases with matching controls were examined. During 12 months of follow-up, the mean number of disease flares and ER visits was higher among patients with positive CDT (1.5 ± 1.4 vs. 0.5 ± 0.9, p = 0.019, 1.3 ± 1.5 vs. 0.4 ± 0.8, p = 0.05, respectively) with a numeric increase of surgical interventions (3 vs. 0). There were no significant differences in disease outcomes between patients with C. jejuni infections and matched controls. Conclusion Clostridium difficile and Campylobacter jejuni are the most common enteric infections among paediatric patients with IBD but only clostridial infection results in a more severe disease course within 12 months of infection.

P818 Venous thromboembolism is rare among hospitalised patients with an inflammatory bowel disease flare: a multicentre retrospective cross-sectional study

Abstract Background Inflammatory bowel disease (IBD) patients have twice the risk of venous thromboembolism (VTE) compared with healthy controls. VTE can occur at both hospitalisation and after discharge. We aimed to assess the prevalence of VTE among IBD patients who were hospitalised with disease flare at three Israeli Hospitals. Methods A retrospective cross-sectional analysis including all IBD patients who were admitted with disease flare at Galilee Medical Center, EMMS Nazareth Hospital and Hadassah Medical Center. Exclusion criteria were patients with confirmed diagnosis of hypercoagulable state or patients on drugs with pro-coagulable potential. Results Eighty-one patients with overall 114 admissions were included in the study. The average age was 42.2 ± 18.5 years. Sixty-six patients (57.9%) were males. Forty-five admissions (39.5%) were due to ulcerative colitis (UC) flare and 69 admissions (60.5%) were secondary to Crohn’s disease (CD) flare. Twenty-eight patients (24.6%) were smokers. Twenty-five patients (21.9%) and 39 patients (34.2%) were on recent biological and steroid treatment (within 3 months). The mean C-reactive protein and albumin levels at the day of discharge were 4.2 ± 4.6 mg/dl (normal range 0–0.5) and 3.5 ± 0.7 g/dl (normal values above 3.2), respectively. During hospitalisation, 57 (50%), 55 (48.2%), 29 (25.4%), 19 (16.7%) and 8 (7%) patients were treated with intravenous steroids, antibiotics, amino-salicylates, surgery and immunomodulators, respectively. Only four patients (3.5 %) were on prophylactic subcutaneous anticoagulation (enoxaparin) throughout their hospital stay and only 1 patient (0.9%) who have not been on anticoagulation developed in-hospital symptomatic VTE episode. Notably, this patient suffering from CD with ileo-colonic involvement developed subclavian vein thrombosis two day after PICC line insertion for total parenteral nutrition to optimise his nutritional state before performing surgery. The mean hospitalisation length was 6.5 ± 6.6 days. Conclusion In-hospital VTE was rare among our IBD patients admitted with disease flare. In fact, the only one VTE event reported in our cohort is probably related to the PICC line insertion and not related to IBD flare. Notably undergoing surgery in our cohort was not correlated with VTE episodes. Further studies are warranted to characterise IBD patients at risk for VTE, to assess the risk factors for in-hospital VTE development and to address further the role of prophylactic anticoagulation among hospitalised IBD patients, mainly those with bloody diarrhoea.

P571 Self-Medication with steroids in ulcerative colitis: Results of a patient survey

Abstract Background Medical treatment of mild-to-moderate flares of ulcerative colitis (UC) is based on topical and oral mesalazine, steroids or a combination of both. Sometimes self-medication with any of them can occur during a flare and it could interfere with clinical practice. Our aim was to assess the prevalence of self-medication with steroids in UC-patients and the reasons for this behaviour. Methods An anonymous cross-sectional survey was developed by representatives of the Spanish working group on Crohn’s disease and UC (GETECCU), the Spanish nursing working group on Inflammatory bowel disease (IBD) (GETEII) and the Spanish associations of patients with CD and UC (ACCU). A link to the online survey was distributed to adult UC patients through 50 Spanish IBD units as well as in the ACCU webpage. Participants voluntarily answered to the survey based on their own experiences. Results A total of 546 patients were included, 61% women, mean age 40 years old. Half of them (51%) were followed-up by IBD specialists, while 47% by general gastroenterologists. Thirty-six (6.6%) patients self-medicated with steroids. The main reasons to self-medicate with steroids were the need for quick relief of symptoms (n = 20, 56%), fear of worsening (n = 17, 47%) and difficulty for getting a medical appointment or being previously prescribed by the doctor (n = 9, 25%, both). Sixty-four per cent of them self-medicate once per year, while 8% self-medicate more than three times per year. Of these patients, 175 (32%) reported that self-medication lasted less than one month, while in 9 (18%) lasted for more than 3 months. Factors related to self-medication with steroids were the increased number of flares (p < 0.001), living with someone who uses oral steroids (p = 0.04), keeping the steroids left after finishing the treatment (p < 0.001), and prescription of corticosteroids in case of worsening by the primary care doctor (p = 0.02). Self-medication was less frequent in those patients who were attended by an IBD specialist (11, 3%), compared of those followed by an internal medicine physician (2, 33%), (p = 0.007), or by a general gastroenterologist (n = 23, 9%), (p = 0.02). Multivariate analysis showed that a higher number of flares [OR 7 (95% CI: 1–32), p < 0.001] and being attended by a general gastroenterologist [OR 0.08 (95% CI=0.01–0.5), p = 0.007] were both associated with a greater frequency of self-medication. Conclusion Self-medication with steroids is not a common practice in patients with UC from Spain. However, there is still room for improvement in clinical practice. Characteristics of the healthcare system and the disease may influence the rate of self-medication in UC patients. This project was endorsed by GETECCU, GETEII, ACCU and funded by MSD Spain.

P228 Cytomegalovirus Infection: is it a cause of flare-up in inflammatory bowel diseases?

Abstract Background The presence of CMV in blood is quite common in patients with severe flares of ulcerative colitis (UC) and Crohn’s disease (CD) and seems to predict an adverse outcome. The impact of antiviral treatment on CMV in this setting (indications and drug options) is an unresolved issue. Our aim was to reassess the CMV role in patients with IBD hospitalised for severe exacerbations, analysing the relationship between CMV positivity, clinical characteristics, antiviral therapy and disease outcomes. Methods We evaluated a homogeneous cohort of 97 consecutive patients with IBD hospitalised from 2012 to 2018. Data regarding age, gender, smoke, familial predisposition, type of IBD, extent, according to Montreal classification, disease activity (clinical and endoscopic), therapy at the time of relapse were registered in a dedicated database. CMV was tested by PCR in whole blood. The relationship between antiviral therapy and disease outcomes (rate of colectomy, mortality) was analysed. Results Among the 97 patients, 51 were females. In the UC group (67 patients, 69.1%), mean age was 48,8, SD ± 17,7 whereas in the CD group (30 patients, 31%), mean age was 39,9 years (SD ± 15,2). Fifteen per cent of patients had a family predisposition for IBD. There were no differences at baseline between UC and CD, except disease duration (longer in UC) and therapy at the time of relapse (high dose steroids more common in UC). Thirty-one patients (32 %) tested positive for CMV on PCR. Smoking habit, shorter disease duration, therapy on admission (high dose steroid and/or immunomodulators) and endoscopic activity assessed by Mayo endoscopic sub-score were the variables significantly related to CMV positivity. Antiviral therapy was adopted in 22% of patients and the decision to treat was based on clinical judgement and viral load. Treated patients had higher endoscopic activity than untreated (Mayo sub-score 3 vs. 2,6, p < 0,004). The mean hospital duration was longer in treated patients 22.3 ( ± 11.1) days, vs. 14,8(+/−8,6) days. 3 patients underwent surgery within 90 days, 2 patients died; all of them were positive for CMV DNA. No significant differences were observed on either colectomy or mortality rate in relation to the use of antiviral therapy. Conclusion This single-centre study confirms that the CMV reactivation during disease flares of IBD is common and related to disease duration, severe endoscopic lesions, and immunosuppression (high dose steroids and/or immunomodulators).Antiviral drugs do not seem to modify surgical outcomes or mortality but increase the hospitalisation length. However, the retrospective design and the limited sample size of the study do not allow to draw definitive conclusions: the real impact on outcome and the role of antiviral therapy will require adequately powered prospective studies.

P623 Cumulative incidence of infliximab use after a first flare of acute severe colitis

Abstract Background Since 2005, infliximab (IFX), an anti-tumour necrosis factor-α agent, has proven to be efficient as salvage and maintenance therapy for ulcerative colitis. In 2011, a randomised controlled comparative trial has demonstrated the short-term efficacy as a second-line treatment for acute severe colitis (ASC). Since then, few studies had evaluated the probability of first IFX use after a first flare of ASC. The aim of this study was to assess the cumulative incidence of IFX use after a first flare of ASC occurring after 2011. Methods Between June 2018 and January 2011, all inpatients with a first non-complicated flare of ASC were retrospectively randomised. Steroid resistance was concluded in patients undergoing colectomy or put into second-line medical therapy. Cumulative incidence of IFX use was evaluated by Fine and Gray model, considering colectomy and death as competing events. Results Twenty-five patients were reviewed (median age: 35y. (14-58y.); 11 females and 14 males). Thirty per cent of patients were active smokers. Only one patient had severe comorbidities. Half of the patients were admitted for an inaugural flare. A family history of an inflammatory bowel disease was noted in 12% of cases. sixteen per cent of patients had extraintestinal manifestations. At the moment of presentation, three-quarters of patients were not receiving any immunosuppressive therapy. Truelove and Witts criteria were present in 70% of cases. The average rates of CRP, plasmatic albumin and haemoglobin were respectively 131 mg/dl(43–260), 28 g/l (19–40), and 11g/dl (6,5-14). Sixty-four per cent of the patients responded to first-line medical therapy. Among patients with steroid-refractory colitis (9 patients), timely colectomy was performed in 1 case, 1 patient received cyclosporin (2mg/Kg per day) and 7 patients received infliximab (5mg/Kg on days 0, 14 and 42). Clinical response to second-line medical therapy was observed in 87% of patients. After a median follow- up period of 26 mo. (0,26-81 mo), 4 patients underwent colectomy: 2 urgent colectomies at the same hospitalisation and 2 subsequent colectomies for chronic active disease. Colectomy free survival rate at 5 years was 82%. Cumulative incidence of first infliximab use at 1 and 5 years was, respectively, 40% and 70%. In multivariate analysis, resistance to steroids (p = 0.0005) and history of thiopurines intake (p = 0.002) were significantly associated with subsequent use of IFX. No death was observed during the analysis period. Conclusion During follow-up, the vast majority of patients needed subsequent IFX use after their first flare of ASC.

P328 Faecal microbiota transplantation as treatment for recurrent Clostridiodes difficile infection in patients with inflammatory bowel disease: Experiences of the Netherlands donor faeces bank

Abstract Background In recent years Faecal Microbiota Transplantation (FMT) is effectively implemented as an approved treatment approach of refractory Clostridiodes difficile infection (rCDI). In patients with inflammatory bowel disease (IBD) the prevalence of co-infection with CDI is higher than in the general population due to the use of immunosuppressive medication and dysbiosis of the bacteria in the colon. Just a small percentage of IBD patients do have an active CDI infection, not to be confused with carriership. Here we report the treatment course and efficacy of FMT provided by the Netherlands Donor Faeces Bank (NDFB) for IBD patients with rCDI. Methods The NDFB was founded to facilitate FMT by providing ready to use donor faeces suspensions for treatment of patients with rCDI in hospitals throughout The Netherlands. A request for FMT is evaluated by the working group (specialists in the fields of Medical Microbiology, Gastroenterology, and Infectious Diseases) to assess the indication of FMT and to formulate a treatment advice for each individual patient taking the comorbidity into account. Prior to FMT, all patients were pre-treated with vancomycin 250 mg for at least 4 days and bowel lavage. In patients with ulcerative colitis as comorbidity, prednisone was added when there was an IBD flare simultaneous. The results of FMT were monitored by prospective collection of outcome data by the NDFB. Results Since the start of NDFB in March 2016 until August 2019, 186 FMT requests to treat 176 (r)CDI patients were reviewed within the NDFB working group including 26 patients with rCDI and IBD. In total, 129 patients (of which 14 suffered from IBD) were treated with 143 FMTs for CDI with a cure rate of 89.9% after a single FMT (116/129). FMT was deemed not suitable in 12 of 26 patients with IBD because patients had C. Difficile carriership instead of an active CDI infection. Fourteen IBD patients were treated with FMT (9 ulcerative colitis, 2 Crohn’s disease and 2 indeterminate colitis). 3/14 patients suffered from rCDI with an active episode of IBD. Of the 14 IBD patients treated with FMT, only one patient developed a relapse of a CDI infection within 2-months (total cure rate 92%). This cure rate does not differ from CDI patients without IBD. Conclusion In IBD patients with rCDI, FMT is equally effective compared with other patients with rCDI. In case of concurrent activity of IBD, pre-treatment with prednisolone in combination with vancomycin appears to be effective.

P182 Bowel Preparation in inflammatory bowel diseases (IBD): preliminary results from a randomised trial evaluating efficacy, tolerability and safety of cleansing solutions in IBD patients

Abstract Background Colonoscopy is the first-line procedure for the diagnosis and management of inflammatory bowel disease (IBD). Data regarding bowel preparation in patients with IBD are scarce. Our aim was to evaluate efficacy, safety and tolerability of the main available colon cleansing formulations in IBD patients: sodium picosulfate with magnesium citrate (SM+MC), 2L polyethylene glycol-ascorbate (2L-PEG-a) and 1L polyethylene glycol-ascorbate (1L-PEG-a). Methods Study design: Phase 4, randomised, single-centre, prescriber and colonoscopist-blinded study. EudraCT Number 2018-001402-28. Patients: IBD patients aged over 18 requiring colonoscopy. Exclusion criteria: pregnant women, past history of bowel resection, severe acute IBD flare or low-quality cleansing score in a colonoscopy performed 12 months prior to enrolment. Patients were randomized 1:1:1 to receive 1L PEG-a, 2L PEG-a or SP+MC; all preparations were administered in a split-dose regimen. Colonoscopies are performed by trained IBD specialists. Endpoints: Primary endpoint: Bowel cleansing using Boston Bowel Preparation Score (BBPS). We considered high-quality cleansing (HQC) a BBPS ≥5. Secondary endpoints: tolerability and patient satisfaction, evaluated via questionnaires filled before and after undergoing colonoscopy. Questionnaires contained items to be ranged on a scale from 1 to 10. Safety was monitored via adverse event reporting, laboratory evaluation at colonoscopy and telephonic follow-up. Statistical analysis: We used Student’s T/ANOVA and χ² tests for comparison between quantitative and qualitative variables, respectively. Software was Stata for Mac OS. We considered statistical significance a p-value < 0.05. Results Seventy-seven patients have been enrolled and subsequently randomised: 31 SP+MC vs. 24 2L-PEG-a vs. 22 1L-PEG-a. Colon cleansing was similar between solutions (% of HQC: SP+MC 100% vs. 2L-PEG-a 91% vs. 1L-PEG-a 95’4%, p = 0.28). Tolerability among the different formulations was also comparable (p = 0.68). Looking at patient satisfaction, instructions for SM+MC were rated higher (p = 0.05). No serious adverse events were reported. Data can be seen in Table 1. Conclusion No differences were observed between bowel preparations in patients with IBD concerning cleansing and tolerability. Instructions for SP+MC were easier from patient’s point of view than the others. Recruiting is still active so definitive conclusions are yet to be reported.

P198 Colorectal cancer diagnosis in patients with inflammatory bowel disease in Spain: A room for improvement

Abstract Background Ulcerative colitis (UC) and Crohn’s disease (CD) are inflammatory bowel diseases (IBD), characterised by chronic inflammation of the digestive tract. IBD patients have an increased risk of developing colorectal cancer (CRC) compared with the general population. A proper screening in this population is essential to guarantee an early CRC diagnosis and maximise the success of the treatment. The aim of the study was to analyse the usual clinical practice in the diagnosis of CRC in IBD patients in Spain, and possible areas of improvement. Methods This preliminary qualitative study was carried out through the creation of four round tables with gastroenterologists and oncologists from different cities of Spain. The opening and closing tables were composed by 1 representative of the Confederation of Associations of Patients with CD and UC of Spain, an expert patient, a nurse from an IBD Unit, a representative of the Spanish Working Group on CD and UC, a gastroenterologist, an oncologist. The first one was necessary to point out the issues that were considered as the most important ones to be discussed in the round tables. In the closing table, all the debates were analysed in order to formulate conclusions. Results According to health professionals, the average delay time from the suspicion of an IBD flare, until the diagnosis of a CRC, is 3 months. The difficulty and delay in the diagnosis of CRC is generally attributed to the fact that the symptoms of the two pathologies usually overlap. Medical specialists currently suggest performing chromoendoscopy, in order to increase the rate of early detection of CRC. However, even if patients’ management and CRC prevention are described by the ECCO guidelines, we identify a lack of standardisation of the techniques for the diagnosis of CRC, which cannot guarantee an equal follow-up of IBD patients at the national level. Also, it can vary not only depending on the geographical area, but also in the centre. The reasons why the follow-up cannot be done – or is not done properly, are the lack of time, human resources, diagnostic tools and patient collaboration. Conclusion From a quantitative point of view, specialists perceive the early CRC underdiagnosis in IBD patients as a minor problem, since they agree that there may be little escaping to the screenings that are routinely performed to these patients. On the other hand, at a qualitative level they recognise it is a major problem, since a delay in diagnosis or misdiagnosis can lead to patient’s death. Thus, hospital administrations should provide resources that allow an adequate follow-up of all IBD patients. Also, the creation of multidisciplinary units would guarantee better management of these patients.

P271 Trends in faecal calprotectin levels during pregnancy and post-partum in healthy women

Abstract Background Faecal calprotectin (FCP) is one of the most widely used non-invasive tools for diagnosis and assessment of inflammatory bowel disease (IBD). Numerous factors can influence FCP levels including weight, smoking status and medications. In clinical practise FCP is commonly used to identify flares during pregnancy. For a test that is widely used minimal data exists on the determinants of normal levels and variations in concentrations during pregnancy in healthy individuals. Our aim is to determine normal FCP levels during pregnancy and post-partum and whether levels change during pregnancy and post-partum in healthy individuals. Methods We performed a prospective study analysing FCP levels from pregnant women at 16- and 34-weeks’ gestation and 4- and 12-weeks post-partum. Basic demographics were collected including age, parity, medical history, BMI and smoking status. Patients with a history of gastrointestinal disorders were excluded. FCP concentrations were measured with a quantitative ELISA assay. Results 98 patients were included in our study. 172 stool samples were collected for analysis. Sixty-two stool samples were collected at 16 weeks gestation, 48 samples from 34 weeks gestation, 38 samples from 4weeks post-partum and 24 samples from 12 weeks post-partum. The median age was 33 years (21–44). Forty-one patients had a BMI > 25 (42%). Sixteen patients were ex-smokers (16%) and one patient was actively smoking (1%). The median FCP levels from 16 weeks gestation was 29.5 (10–476), median level from 34 weeks gestation was 25.6 (10–259), from 4 weeks post-partum was 23.4 (10–318) and 12 weeks post-partum was 29.4 (10–216) (Table 1). There was no significant change in median FCP levels over the course of pregnancy and post-partum (p = 0.294). Interestingly median FCP levels were normal at all time points however we saw a slight numerical increase in FCP levels during pregnancy in patients whose BMI was > 25 and this reached statistical significance at 4weeks post-partum (p = 0.01) (Table 1, Graph 1). There was also a significant increase in FCP at 4 weeks post-partum in patients who were ex-smokers (p = 0.004). (Table 1, Graph 1). Conclusion FCP levels are not affected by physiological changes in pregnancy or post-partum in normal healthy individuals without IBD. This confirms FCP is an effective tool for identifying flares of colitis during pregnancy. However, when using this tool, one should be aware that levels can be slightly altered by a patients’ smoking history and their weight and a detailed clinical history is essential when interpreting results.

Does early corticosteroid therapy affect prognosis in IBD patients hospitalized with Clostridioides difficile infection?

Corticosteroids (CS) therapy to Clostridioides difficile infection (CDI) in inflammatory bowel disease (IBD) flares may worsen CDI outcomes. Assess the impact of early CS exposure on outcomes of IBD patients diagnosed with CDI. Retrospective study of IBD patients admitted with first-time CDI between 2002 and 2018. Comparisons were made based on CS exposure 48h from admission. Patients were further subdivided to 5 groups based on CS-antibiotics temporal exposure. The primary outcome was all-cause mortality or colectomy within 3months. Secondary outcomes were colectomy and mortality rates at 1year, length of stay, readmissions, bacteremia, and diarrhea improvement by day 7/discharge. Cox proportional hazard model and Kaplan-Meier curves were used to assess the effects on survival. Logistic and ordinal regressions were used to assess primary and secondary outcomes. One hundred thirteen patients (64 CD, 46 UC, and 3 IBDU) were included, 82 (72.5%) received early CS. At baseline, CRP was significantly lower and albumin was higher in the group not exposed to early CS. At 3months, 4 (4.8%) patients required colectomy and 6 (5.8%) died (p = NS). Length of stay was significantly reduced among patients not exposed to early CS. All other endpoints were not associated with CS exposure. In subgroup analysis, the primary outcome was not significantly different among the sub-groups. Mortality rate at 1year was significantly lower in patients who did not receive antibiotics for CDI. Early CS therapy in IBD patients hospitalized with CDI is not associated with worse clinical outcomes. However, additional prospective research is required.

Safety of Recombinant Zoster Vaccine in Patients with Inflammatory Bowel Disease.

Patients with inflammatory bowel disease (IBD) are at increased risk of developing herpes zoster. In October 2017, the FDA approved a two-dose adjuvanted, recombinant herpes zoster vaccine (RZV). There is a theoretical concern that vaccine adjuvants may cause flares in patients with immune-mediated diseases. We aimed to assess the rates of IBD flare and adverse reactions after administration of RZV in a cohort of patients with IBD. We conducted a prospective observational study of patients with IBD who received RZV between February 2018 and July 2019 at a tertiary IBD referral center. IBD activity scores were collected from patients during office visit or phone call after vaccination. The primary outcome was rate of IBD flare, defined as an increase in IBD activity, resulting in escalation of medical therapy, following vaccination. The secondary outcomes were rates of local and systemic adverse reactions after vaccination. We identified 67 patients (28 with ulcerative colitis and 39 with Crohn's disease) who received at least one dose of RZV. The two-dose vaccine series was completed by 55 patients (82%). Median duration of follow-up after vaccination was 207days. One case of IBD flare was identified. No cases of herpes zoster were identified. Local and systemic adverse reactions were reported in 74.6% and 56.7% of patients, respectively. In this cohort of 67 patients, a low rate of IBD flare (1.5%) was observed after RZV administration. Rates of local and systemic adverse reactions were comparable to those seen in the RZV clinical trials.

Consequences and management of COVID-19 on the care activity of an Inflammatory Bowel Disease Unit.

COVID-19 has altered the usual practice of medicine and the state of emergency declared in Spain on March 14th has considerably changed the activity of inflammatory bowel disease (IBD) units. The aim of this study was to evaluate the consequences of COVID-19 on the IBD Unit's activity and provide information on restructuring with available resources. an observational study was performed in a referral hospital in Madrid (Spain). Type of appointment, loss of follow-up, hospital admission, treatment changes, endoscopic activity, surgeries and blood tests were evaluated between March 15th and May 15th, 2020. This data was compared with the usual activity a year before. among the 510 patients included, 476 (93.33 %) received had a remote consultation, representing an increase of 92.38 % compared with the previous year (0.95 %). There was a loss of follow-up in 26 patients (5.1 %) vs 15 (3.58 %) the previous year. A total of 60 (35.09 %) blood tests, 64 (76.19 %) endoscopies and all scheduled surgeries were suspended. Besides, 484 (94.9 %) patients remained adherent vs 417/419 (99.5 %) in the pre-pandemic period and 48 (9.41 %) reported symptoms of an IBD flare. Thirty-nine (7.6 %) patients developed symptoms suggestive of COVID-19. a large number of tests and on-site outpatient visit consultations were suspended. However, a rapid adaptation to telemedicine allowed these patients to be closely followed up. Although it was possible to maintain therapeutic compliance, with a loss to follow-up slightly higher than the previous year, suspensions and delays of tests could have significant negative consequences in the long term.

Exposure to Intravenous Opioids Is Associated With Future Exposure to Opioids in Hospitalized Patients With Inflammatory Bowel Diseases

Background & AimsOpioid use is associated with increased mortality in patients with inflammatory bowel diseases (IBD). Hospitalized patients with IBD often receive high-potency intravenous opioids (IVOPIs). It is not known whether exposure to IVOPIs affects post-discharge opioid use or complications. We investigated the association between inpatient administration of IVOPIs and a post-discharge opioid prescription (OPIRx) in patients with IBD. MethodsWe performed a retrospective cohort study of 862 adults with IBD hospitalized at a large urban academic health system from March 1, 2017 through April 10, 2018. We collected clinical data from the electronic health records and used multivariable mixed-effect logistic regression to assess the association between inpatient opioid exposure and OPIRx-within 12 months while adjusting for confounders. IV and non-IVOPI exposures were evaluated as binary variables. IVOPI exposure was also evaluated as a continuous variable in IV morphine mg equivalents/length of stay (IVMMEs/day). ResultsMultivariable mixed-effect logistic regression demonstrated a significant association between IVOPIs and OPIRx (IV vs no IVOPIs odds ratio [OR], 3.3; 95% CI, 1.7–6.4 and IVMMEs/day OR, 1.1; 95% CI, 1.0–1.1). Subgroup analysis of patients with IBD flares (n = 621) identified a significant association between IVOPIs and OPIRx (IV vs no IVOPIs OR, 5.4; 95% CI, 2.6–11.0). Among patients who did not receive IVOPIs, there was a significant association between oral/transdermal opioids and OPIRx (non-IVOPIs vs no opioids OR, 4.2; 95% CI, 1.0–16.8). ConclusionsInpatient IV and non-IV opioid use are associated with post-discharge opioid exposure in patients with IBD, with a dose-dependent effect. Alternative analgesics should be considered for hospitalized patients with IBD, to minimize risk of future opioid use.

Study of Drug-Drug and Drug-Food Interactions of Mesalazine Through FTIR and DSC

A well-established drug used in the management of inflammatory bowel disease is 5-aminosalicylic acid (e.g. Mesalazine or Mesalamine). For the treatment of mild to moderate flares of ulcerative colitis and Crohn’s disease, Mesalazine has been used as the first line drug in both western and Asian countries due to its superiority over other drugs in terms of side effects and toxicities. Besides, some other drugs are also prescribed for total resolution of different symptoms of ulcerative colitis and associated diseases, which include Acetaminophen, Metronidazole and Vitamin D3. Moreover, physicians instruct that Mesalazine should be taken at least one hour before meal. So, there are enough scopes of studying the drug-food interaction of Mesalazine to assess if there is any incompatibility present with food. Thus, in the present study, Mesalazine and physical mixtures of Mesalazine (1:1) in solid form along with the aforementioned drugs were prepared and analyzed to evaluate the compatibility among them using Fourier Transform Infrared Spectroscopy (FTIR) and Differential Scanning Calorimetry (DSC). In addition, interactions of Mesalazine with food stocks such as chicken and vegetable broth, fruit juice, milk and soybean oil were studied using FTIR, considering these as the common sources of protein, vitamin, fiber, minerals and fat. From this study, it was interpreted that, major interactions of Mesalazine were present with food samples. Besides, FTIR and DSC data revealed subtle clues of incompatibilities between Mesalazine and the other two drugs except Vitamin D3. So, the results may prove to be useful for related research works in future
 Dhaka Univ. J. Pharm. Sci. 18(2): 257-269, 2019 (December)

Efficacy of Fecal Microbiota Transplantation for Recurrent C. Difficile Infection in Inflammatory Bowel Disease.

Clostridioides difficile infection (CDI) is associated with poor outcomes in inflammatory bowel disease (IBD) patients. Data are scarce on efficacy of fecal microbiota transplant (FMT) for recurrent CDI in IBD patients. We reviewed health records of IBD patients (18 years of age or older) with recurrent CDI who underwent FMT. Outcomes of FMT for CDI were assessed on the basis of symptoms and stool test results. We included 145 patients (75 women [51.7%]; median age, 46 years). Median IBD duration was 8 (range, 0-47) years, 36.6% had Crohn disease, 61.4% had ulcerative colitis, and 2.1% had indeterminate colitis. Median number of prior CDI episodes was 3 (range, 3-20), and 61.4% had received vancomycin taper. Diarrhea resolved after FMT in 48 patients (33.1%) without further testing. Ninety-five patients (65.5%) underwent CDI testing owing to post-FMT recurrent diarrhea; 29 (20.0%) had positive results. After FMT, 2 patients received empiric treatment of recurrent CDI without symptom resolution, suggesting IBD was the cause of symptoms. The overall cure rate of CDI after FMT was 80.0%, without CDI recurrence at median follow-up of 9.3 (range, 0.1-51) months. Forty-three patients (29.7%) had planned IBD therapy escalation after CDI resolution; none de-escalated or discontinued IBD therapy. Overall, 7.6% had worsening IBD symptoms after FMT that were treated as new IBD flares. No clinical predictors of FMT failure were identified. Few patients had new IBD flare after FMT. Fecal microbiota transplantation effectively treats recurrent CDI in IBD patients but has no apparent beneficial effect on the IBD course.

Is Bariatric Surgery Safe and Effective in Patients with Inflammatory Bowel Disease?

The rate of obesity is rapidly increasing in patients with inflammatory bowel disease (IBD), but whether bariatric surgery in patients with IBD is safe and effective is not well understood. A retrospective review of patients with IBD undergoing bariatric surgery across a multi-state health system was performed. Thirty-day postoperative outcomes, weight loss, and long-term complications were recorded. Thirty-one patients (81% female) with IBD and a mean preoperative body mass index (BMI) of 42.4 kg/m2 underwent 32 bariatric operations (n = 14 Roux-en-Y gastric bypass, n = 14 sleeve gastrectomy, n = 4 gastric band). Short-term infectious complications included superficial surgical site infection (n = 2), infected intra-abdominal hematoma (n = 1), and a hepatic abscess (n = 1). Percent excess weight loss was 57.2% (n = 25) at 6 months, 62.9% (n = 22) at 12 months, and 57.4% (n = 11) at 24 months. No IBD flares requiring surgery were observed at a median follow-up of 2.7 years (interquartile range, 0.8-4.2 years). In carefully selected patients with IBD, bariatric surgery appears safe with respect to short-term infectious complications and results in sustained weight loss until at least 2 years postoperatively.