Clostridium Difficile Infection In Patients Research Articles

Comparison of trends in Clostridioides difficile infections in hospitalised patients during the first and second waves of the COVID-19 pandemic: A retrospective sentinel surveillance study.

SummaryBackgroundDuring the COVID-19 pandemic, several factors, such as improved hand hygiene, social distancing, and restricted hospital referral, may have had an influence on the epidemiology of Clostridioides difficile infections (CDI).MethodsThe annual CDI incidence rate of nine hospitals participating in the Dutch sentinel CI surveillance with complete data was compared between 2020 and the previous five surveillance years. Trends in characteristics of hospitalised CDI patients in 21–24 participating hospitals were compared between the first (March 13–May 12, 2020) or second Dutch COVID-19 wave (September 17, 2020-January 1, 2021) and the same calendar periods in 2015 through 2019. All analyses were adjusted for trend changes over time.FindingsThe annual CDI incidence rate in 2020 was lower compared to previous years. During the second wave, the percentage of CDI patients with severe CDI was higher compared to earlier (25·8% in 2020 vs 17·9% in 2015-2019 (RR 1·6; 95%CI 1·1-2·3)). After adjustment for delayed C. difficile diagnostics (≥8 days from start symptoms), the increase disappeared. Delayed C. difficile diagnostics was indeed more common during the second wave (RR 1·7; 95%CI 1·1-2·6), but only for community-onset CDI (CO-CDI).InterpretationThis study shows that a higher percentage of severe CDI cases was observed during the second COVID-19 wave. This may partially be caused by delayed diagnostics, potentially due to decreased visits to a physician or restricted hospital referral for CO-CDI patients.FundingDutch ministry of Health.

EPH73 Risk Factors for Recurrences of Clostridioides Difficile Infection in the Medicare Population Age 65+ YEARS

Clostridioides difficile infection (CDI) recurrences are associated with substantial clinical and economic burden including high mortality and high hospitalization cost. We analyzed recently available 100% Medicare Fee-for-Service (FFS) claims to assess recurrence and identify risk factors for patients experiencing 1, 2, and 3+ recurrences of CDI (rCDI) to inform CDI patient management.

Clinical and microbiological risk factors for community-associated Clostridioides difficile infections

Background: The incidence of community-associated (CA) Clostridioides difficile infection (CDI) has increased in Korea. In this study, we evaluated CA-CDI risk factors in terms of clinical features and ribotype considering its region-specific molecular epidemiology. Methods: A retrospective case-control study was performed on two groups of CDI patients: 127 subjects with CA-CDI and 265 subjects with healthcare-associated (HA)-CDI. Risk factors for CA-CDI were evaluated in terms of clinical and microbiological features such as toxin type and ribotype. Results: A comparison of the two groups of CDI patients revealed that inflammatory bowel disease, diarrhea, abdominal pain, and fever were more closely associated with CA-CDI. The toxin types and ribotypes of C. difficile were similar between the two groups. After adjusting for variables, no risk factors were identified for CA-CDI compared with HA-CDI. Conclusion: Specific risk factors for CA-CDI were not identified in this study.

Incidence, Attributable Mortality, and Healthcare and Out-of-Pocket Costs of Clostridioides difficile Infection in US Medicare Advantage Enrollees.

US attributable Clostridioides difficile infection (CDI) mortality and cost data are primarily from Medicare fee-for-service populations, and little is known about Medicare Advantage Enrollees (MAEs). This study evaluated CDI incidence among MAEs from 2012 to 2019 and determined attributable mortality and costs by comparing MAEs with and without CDI occurring in 2018. This retrospective cohort study assessed CDI incidence and associated mortality and costs for eligible MAEs ≥65 years of age using the de-identified Optum Clinformatics Data Mart database (Optum; Eden Prairie, Minnesota, USA). Outcomes included mortality, healthcare utilization, and costs, which were assessed via a propensity score-matched cohort using 2018 as the index year. Outcome analyses were stratified by infection acquisition and hospitalization status. From 2012 to 2019, overall annual CDI incidence declined from 609 to 442 per 100 000 person-years. Although the incidence of healthcare-associated CDI declined overall (2012, 53.2%; 2019, 47.2%), community-associated CDI increased (2012, 46.8%; 2019, 52.8%). The 1-year attributable mortality was 7.9% (CDI cases, 26.3%; non-CDI controls, 18.4%). At the 2-month follow-up, CDI-associated excess mean total healthcare and out-of-pocket costs were $13 476 and $396, respectively. Total excess mean healthcare costs were greater among hospitalized (healthcare-associated, $28 762; community-associated, $28 330) than nonhospitalized CDI patients ($5704 and $2320, respectively), whereas total excess mean out-of-pocket cost was highest among community-associated hospitalized CDI patients ($970). CDI represents an important public health burden in the MAE population. Preventive strategies and treatments are needed to improve outcomes and reduce costs for healthcare systems and this growing population of older US adults.

Clinical Determinants Predicting Clostridioides difficile Infection among Patients with Chronic Kidney Disease.

The majority of recently published studies indicate a greater incidence rate and mortality due to Clostridioides difficile infection (CDI) in patients with chronic kidney disease (CKD). The aim of this study was to assess the clinical determinants predicting CDI among hospitalized patients with CKD and refine methods of prevention. We evaluated the medical records of 279 patients treated at a nephrological department with symptoms suggesting CDI, of whom 93 tested positive for CDI. The survey showed that age, poor kidney function, high Padua prediction score (PPS) and patients’ classification of care at admission, treatment with antibiotics, and time of its duration were significantly higher or more frequent among patients who suffered CDI. Whereas BMI, Norton scale (ANSS) and serum albumin concentration were significantly lowered among CDI patients. In a multivariate analysis we proved the stage of CKD and length of antibiotics use increased the risk of CDI, whereas higher serum albumin concentration and ANSS have a protective impact.

Clostridioides difficile Infection in Liver Cirrhosis: A Concise Review

Clostridium difficile is a Gram-positive bacillus with fecal-oral transmission and is currently one of the most common nosocomial infections worldwide, which was renamed Clostridioides difficile in 2016. Clostridioides difficile infection (CDI) is a prevalent infection in cirrhosis and negatively affects prognosis. This study aimed to provide a concise review with clinical practice implications. The prevalence of CDI in cirrhotic patients increases, while the associated mortality decreases. Multiple groups of risk factors increase the likelihood of CDI in patients with cirrhosis, such as antibiotic use, the severity of cirrhosis, some comorbidities, and demographic aspects. Treatment in the general population is currently described in the latest guidelines. In patients with cirrhosis, rifaximin and lactulose have been shown to reduce CDI risk due to their modulatory effects on the intestinal flora, although conflicting results exist. Fecal microbiota transplantation (FMT) as a treatment for the second or subsequent CDI recurrences has demonstrated a good safety and efficacy in cirrhosis and CDI. Future validation in more prospective studies is needed. Screening of asymptomatic patients appears to be discouraged for the prevention currently, with strict hand hygiene and cleaning of the ward and medical equipment surfaces being the cornerstone of minimizing transmission.

Does Fidaxomicin reduce Cure and Recurrence rates compared to Vancomycin in Clostridium Difficile Infection patients?: A Systematic Review and Meta-analysis

Does Fidaxomicin reduce Cure and Recurrence rates compared to Vancomycin in Clostridium Difficile Infection patients?: A Systematic Review and Meta-analysis

Ramifications and healthcare costs of Clostridioides difficile infections in hospitalized patients with solid tumors.

e18801 Background: Clostridioides difficile infection (CDI) is notorious for its perilous effect on frail patients, but its assault is even more so threatening on cancer patients as they are more prone to CDI due to damage to intestinal mucosa by chemotherapy agents and weak immune system, hence higher risk of getting affected from hospital-acquired infections. Here we analyze National inpatient sample database (NIS) of hospitalized patients with solid tumors to find out aftermath of CDI in this particular patient population. Methods: We used NIS database from year 2019 and recruited all patients admitted with C. diff colitis with underline solid tumors with or without metastatic disease. We used international classification of disease,10th revision (ICD-10) codes to identify these patients. Our outcomes of interest were all cause inpatient mortality, acute kidney injury (AKI), sepsis, ICU admission, pressor use and hospital resource utilization including mean length of stay (LOS) and mean total charges. Using STATA 17, we performed the multivariate regression analysis. Results: A total of 15,161 (1.41%) hospitalizations due to principal diagnosis of C. diff Colitis were recorded in solid tumor patients in year 2019. Patients with history of solid tumors who were admitted with C. diff colitis had higher adjusted odds of all-cause in-hospital mortality (AOR 1.23, 95% CI1.08-1.41, P 0.002) compared to patients without underline solid tumor. These patients also had higher odds of sepsis (AOR 2.22, 95% CI 1.89-2.59, P < 0.001), AKI (AOR 1.91, 95% CI 1.73-2.10, P < 0.001), ICU admission (AOR 1.66, 95% CI 1.39-1.97, P < 0.001) and pressors use (AOR 1.82, 95% CI 1.38-2.40, P < 0.001). Patients with underline solid tumors who developed C. diff colitis had increased mean LOS (AOR 3.88, 95% CI 3.41-4.34, P < 0.001). These patients also incurred more hospital charges (Co-efficient 33836$, 95% CI 25907$-41766$, p < 0.001). [Table]. Conclusions: Patients with solid tumors admitted with CDI have an increased risk of sepsis, AKI, ICU admission and in-hospital mortality. They also have a significantly longer duration of hospital stay; hence higher cost of care. There is a dire need for awareness regarding strict contact precautions, hand hygiene, effective environmental cleaning, minimizing antibiotics use/adherence to antibiotic stewardship programs, using prophylactic vancomycin where indicated, avoidance of unnecessary hospital visits utilizing telehealth, etc. and aggressive management of CDI in patients admitted to hospital with solid tumors.[Table: see text]

Outcomes of clostridioides difficile infection in patients with hematopoietic stem cell transplant.

e19054 Background: Hematopoietic stem cell transplantation (HSCT) recipients are at an increased risk for Clostridioides difficile infections (CDI). Despite it being the main cause of nosocomial enterocolitis in this group of patients, diagnosis of CDI remains challenging and carries significant morbidity and mortality. This is usually due to multiple comorbidities, recurrent antibiotics administration, prolonged immunosuppression, and lengthy hospitalization. This study aims to look more into outcomes and predictors of CDI in HSCT patients in terms of incidence, and mortality. Methods: The United States Nationwide Inpatient Sample was used to extract hospitalization data of patients admitted between 2016 to 2019. Using ICD10 revision codes, we identified adults with a discharge diagnosis of CDI and concomitant HSCT. The control group included non-HSCT patients with CDI. The primary outcome was in-hospital mortality. Secondary outcomes were the length of stay (LOS) and hospital charges. Additionally, predictors for developing CDI and dying from CDI were calculated in HSCT patients. Multivariate logistic regression was used to adjust for relevant variables. Results: An estimated 1,235,465 patients were admitted with CDI during the study period. CDI incidence per 100 discharges was higher among HSCT patients at 4.0% vs. 1.0% in the general population. After adjusting for comorbidities and demographic variables, HSCT was independently associated with increased odds of mortality (adjusted odds ratio [AOR] 1.47 (95%CI 1.20-1.80 and P <0.01). Mean length of stay and hospital charges increased by 1.76 days (95%CI 0.90-2.62, P < 0.01) and $59,023 (95%CI $35,940-$82,105, P < 0.01), respectively, in the HSCT group. In the HSCT group, patients with severe liver disease, malnutrition, and graft vs. host disease showed a significantly higher incidence of CDI. Predictors of mortality of HSCT patients and CDI are outlined in the attached table. Conclusions: HSCT recipients are at an increased risk for CDI compared to general population. LOS, total hospital charge, and mortality rate were significantly higher. The risk of CDI was found to be significantly higher in patients with moderate to severe liver disease, graft vs host disease, and malnutrition. The odds of mortality were found to be the highest in patients older than 65 years and those with congestive heart failure, moderate to severe liver disease, graft vs host disease, or malnutrition.[Table: see text]

Gut Microbiota and Metabolite Changes in Patients With Ulcerative Colitis and Clostridioides difficile Infection.

BackgroundPatients with ulcerative colitis (UC) are at an increased risk of developing Clostridioides difficile infection (CDI), which in turn leads to poor outcomes. The gut microbial structure and metabolites in patients with UC and CDI have been scarcely studied. We hypothesized that CDI changes the gut microbiota and metabolites of patients with UC.Materials and MethodsThis study included 89 patients: 30 healthy controls (HC group), 29 with UC alone (UCN group), and 30 with UC and CDI (UCP group). None of the participants has been exposed to antibiotic treatments during the 3 months before stool collection. Stool samples were analyzed using 16S rRNA gene sequencing of the V3–V4 region and gas chromatography tandem time-of-flight mass spectrometry.ResultsThe UCN group displayed lower diversity and richness in gut microbiota and a higher relative abundance of the phylum Proteobacteria than the HC group. There were no significant differences between the UCN and UCP groups in the α-diversity indices. The UCP group contained a higher relative abundance of the genera Clostridium sensu stricto, Clostridium XI, Aggregatibacter, and Haemophilus, and a lower relative abundance of genera Clostridium XIVb and Citrobacter than the UCN group. In the UCP group, the increased metabolites included putrescine, maltose, 4-hydroxybenzoic acid, 4-hydroxybutyrate, and aminomalonic acid. Spearman’s correlation analysis revealed that these increased metabolites negatively correlated with Clostridium XlVb and positively correlated with the four enriched genera. However, the correlations between hemoglobin and metabolites were contrary to the correlations between erythrocyte sedimentation rate and high-sensitivity C-reactive protein and metabolites.ConclusionOur study identified 11 differential genera and 16 perturbed metabolites in patients with UC and CDI compared to those with UC alone. These findings may guide the design of research on potential mechanisms and specific treatments for CDI in patients with UC.

Surgical Outcome in Laparoscopic Abdominal Surgical Operations with Clostridium Difficile Infection.

Introduction: Postoperative Clostridium difficile infection (CDI) has associated morbidity, but it is unknown how it impacts different operations. We sought to determine the incidence and postoperative morbidity following abdominal surgery.Method: The National Surgical Quality Improvement Program database (2015-2019) was utilized to evaluate adult (≥18 years-old) patients who developed CDI following laparoscopic abdominal operations. Univariate and multivariate analysis were performed to evaluate outcomes.Results: A total of 973338 patients were studied and the overall incidence of CDI was .3% within 30 days of operation. Colorectal surgery had the highest incidence of CDI (1601/167949,1.0%) with significantly longer mean length of stay (LOS) (8.0 days± 9.0, P < .01) compared to other surgical procedures. CDI patients also had a longer mean length of stay (6.6± 8.0 vs 2.1 ± 3.6 days, P < .01) and increased mortality (1.8% vs .2%, AOR: 4.64, CI: 3.45-5.67, P < .01) compared to patients without CDI.Conclusions: This national analysis demonstrates that CDI is a significant complication following abdominal surgery and is associated with increased LOS and mortality. Furthermore, laparoscopic colorectal surgery appears to have the greatest risk of CDI. Future research is needed to determine the exact cause in order to decrease the incidence of CDI by reconsidering the protocol of antibiotic use within the high-risk population.

The epidemiological and clinical study of patients with &lt;i&gt;clostridium difficile&lt;/i&gt; enterocolitis in Varna, Bulgaria

Introduction. Clostridium difficile infections (CDI) remain a global health concern. Currently, no unified approach to the diagnostics and determining severity of these infections despite their high urgency throughout the world was proposed. The aim of the study is to identify risk factors for CDI, investigate clinical and epidemiological features of the disease course and potential for using the ATLAS scale to assess its severity. Materials and methods. 36 CDI patients hospitalized at the Infectious Disease Clinic of Varna were analyzed during the period from January 2018 until June 2019. Clinical and epidemiologic study was conducted. The diagnosis was made by using a rapid immunochromatographic test; CDI patient stratification was performed by ATLAS scoring system. Results and discussion. Within the aforementioned period, 1100 patients were hospitalized at the Infectious Disease Clinic of Varna, and CDIs were reported in 3,3% of cases. The most affected were elderly individuals (the mean age was 69,816,4 years old) most of whom were females (92%) with only 6% of males. The following risk factors were investigated: comorbidities 32 patients (88,89%), recent hospitalization 19 patients (52,78%), antibiotic use 31 patients (86,11%). Twenty-four patients (66,67%, ATLAS score 4 points) had mild CDI, whereas moderate form of CDI was observed in 12 patients (33,33%). No severe CDI or death were observed. The characteristic clinical presentation included fever, diarrhea and abdominal cramping. The treatment was implemented according to the national and international recommendations by using oral Metronidazole for 11 patients (30,56%), Vancomycin for 12 patients (33,33%), or both for 13 patients (36,11%). Conclusion. Patients at risk with symptoms of enterocolitis and a history of antibiotic use or hospitalizations should be screened for the presence of toxin-forming strains of Clostridium difficile. According to the European Centre for Disease Prevention (ECDC) the diagnostic yield of CDI may be increased by using two-step protocol, whereas the ATLAS score system may be a useful tool for routine evaluation of patients with CDI.

Risk Factors of Severe Clostridioides difficile Infection; Sequential Organ Failure Assessment Score, Antibiotics, and Ribotypes.

We aimed to determine whether the Sequential Organ Failure Assessment (SOFA) score predicts the prognosis of patients with Clostridioides difficile infection (CDI). In addition, the association between the type of antibiotic used and PCR ribotypes was analyzed. We conducted a propensity score (PS)-matched study and machine learning analysis using clinical data from all adult patients with confirmed CDI in three South Korean hospitals. A total of 5,337 adult patients with CDI were included in this study, and 828 (15.5%) were classified as having severe CDI. The top variables selected by the machine learning models were maximum body temperature, platelet count, eosinophil count, oxygen saturation, Glasgow Coma Scale, serum albumin, and respiratory rate. After propensity score-matching, the SOFA score, white blood cell (WBC) count, serum albumin level, and ventilator use were significantly associated with severe CDI (P < 0.001 for all). The log-rank test of SOFA score ≥ 4 significantly differentiated severe CDI patients from the non-severe group. The use of fluoroquinolone was more related to CDI patients with ribotype 018 strains than to ribotype 014/020 (P < 0.001). Even after controlling for other variables using propensity score matching analysis, we found that the SOFA score was a clinical predictor of severe CDI. We also demonstrated that the use of fluoroquinolones in hospital settings could be associated with the PCR ribotype in patients with CDI.

Clostridioides difficile infection (CDI) epidemiology and patient characteristics in Switzerland

ObjectivesClostridioides difficile infection (CDI) is a disease with high morbidity and mortality rates. The objective of this study was to describe CDI epidemiology and patient characteristics over a 5-year period in Switzerland and assess risk factors for mortality, recurrence and severe CDI. Patients and methodsWe retrospectively included all consecutive CDI cases having occurred in adult patients hospitalized in two tertiary centers: the Lausanne University Hospital (1000 beds) and the University Hospital of Zurich (900 beds), between 2014 and 2018. Suspected cases of CDI were identified from the microbiology laboratory database on the basis of a positive test and confirmed by records review. ResultsDuring first CDI episodes, the median age was 67 years and the median Charlson comorbidity index (CCI) score was 5. All in all, 299 out of 826 patients (36.2%) had severe infection based on the Infectious Diseases Society of America criteria. In the multivariable analysis, CCI was associated with increased risk of mortality. None of the factors recorded on admission were significantly associated with increased risk of recurrence. In the multivariable analysis, male sex and CCI were associated with severity, while immunosuppression was associated with less severe presentation. ConclusionsIf we did not identify any criteria on admission that could be predictive of recurrences, this could be explained the retrospective nature of the study. A higher comorbidity index is a key driver for severe CDI and mortality. Reporting of CDI is not mandatory in Switzerland; structuration of CDI reporting should be a short-term priority.

Rifaximin Therapy for Patients With Metronidazole-Unresponsive Clostridium difficile Infection.

BackgroundClostridium difficile infection (CDI) is a leading cause of hospital-acquired diarrhea. Rifaximin is an antibiotic that offers marginal resistance to C. difficile bacteria. This study was conducted to evaluate the efficacy of rifaximin in metronidazole non-responsive CDI patients.MethodsA cross-sectional study was performed from August 2019 to May 2020 at the Lahore General Hospital, Lahore, Pakistan. A total of 200 cases were included. Patients who developed diarrhea after receiving antibiotics for seven days and a positive C. difficile toxin stool test as detected by the enzyme immunoassay (BioCheck, Inc., CA) were diagnosed with CDI. Only patients who were unresponsive to metronidazole therapy were enrolled in our analysis. Two groups were formed. The intervention group was administered 200 mg tablets of rifaximin three times a day for 10 days. For patients in the control group, no new treatment was started. The efficacy of rifaximin was defined in terms of the resolution of diarrhea after two weeks of therapy and a negative stool test. All data were recorded in a predefined pro forma.ResultsThe mean age of 45.41 ± 8.54 years was found in the intervention group. The majority of the patients were aged 35-50 years. The majority of the patients had watery diarrhea, abdominal cramping, and loss of appetite on presentation. Rifaximin was found to be significantly effective in the resolution of symptoms of CDI, which was previously unresponsive to metronidazole (p<0.00001). it was found that the duration of diarrhea of more than three weeks was significantly associated with failure of therapy (p=0.03).ConclusionWe concluded that rifaximin therapy is effective for patients of CDI non-responsive to metronidazole in more than 65% of the cases. Even though several new developments are made to address the concerned subject, such as microbiota transplantation, antibiotics, and immunotherapy, rifaximin can be considered for patients with metronidazole non-responsive CDI.

Effectiveness and Safety of Fecal Microbiota Transplantation for Clostridioides Difficile Infection: Results From a 5344-Patient Cohort Study

Effectiveness and Safety of Fecal Microbiota Transplantation for Clostridioides Difficile Infection: Results From a 5344-Patient Cohort Study

Disordered Intestinal Microbial Communities During Clostridioides difficile Colonization and Subsequent Infection of Hepatic Cirrhosis Patients in a Tertiary Care Hospital in China.

Patients with hepatic cirrhosis are more susceptible to Clostridioides difficile infection (CDI) and colonization with Clostridioides difficile (C. difficile). Asymptomatic C. difficile colonization is thought to predispose to subsequent CDI. However, the dynamic gut microbiota changes remain unclear. In this study, we used 16S rRNA gene sequencing to longitudinally monitor alterations in the intestinal microbiota of 22 hepatic cirrhosis patients with toxigenic C. difficile colonization at admission (pre-CDI) and developed CDI during hospitalization, subdivided into pre-CDI and CDI. 21 hospitalized cirrhotic patients without C. difficile colonization served as controls (HC). Compared with HC, pre-CDI and CDI samples had significantly decreased microbial richness and diversity, a significantly higher relative abundance of opportunistic pathogen Enterococcus, and a lower relative abundance of beneficial symbionts, such as Faecalibacterium, Dorea, and Roseburia. Three biomarkers showed high accuracy for distinguishing pre-CDI samples from HC with an area under the curve (AUC) up to 0.81. In conclusion, our study explored the changes of the gut microbiome before and after CDI. The gut microbial richness as well as diversity in CDI patients were notably reduced, relative to controls. Imbalance of the intestinal flora may be related to the risk for development of CDI. Identifying key members of the gut microbiota and illustrating their roles and mechanisms of action in CDI development are important avenues for future research.

Clostridium difficile infection after ileostomy closure and anastomotic failure in rectal cancer surgery patients.

BackgroundDiverting ileostomy during resection of rectal cancer is frequently performed in patients at risk of anastomotic failure. Clostridium difficile infection (CDI) is reported to be frequent in patients who receive ileostomy closure with a questionable association to postoperative anastomosis leak. The primary aim of this study was to determine the incidence of CDI following ileostomy closure in patients who underwent rectal cancer surgery; the secondary aim was to assess the rate of postileostomy closure CDI in patients who presented with leakage at the original colorectal anastomosis site.MethodsMedical records of patients with rectal cancer who underwent ileostomy closure between January 2015 and December 2019 were retrospectively reviewed. All patients had previously received resection and anastomosis for primary rectal cancer with diverting ileostomy. Data regarding CDI incidence, preoperative status, perioperative management, and clinical outcomes were collected. CDI positivity was determined by direct real-time PCR and enzyme-linked fluorescent assays for detecting toxin A and B.Statistical analyses were computed for CDI risk factors.ResultsA total of 1270 patients were included and 208 patients were tested for CDI owing to colitis-related symptoms. The incidence of CDI was 3.6 per cent (46 patients). Multivariable analysis for CDI risk factors identified adjuvant chemotherapy (hazard ratio (HR) 2.28; P = 0.034) and colorectal anastomosis leakage prior to CDI (HR 3.75; P = 0.008). Finally, patients with CDI showed higher colorectal anastomosis leakage risk in multivariable analysis after ileostomy closure (HR 6.922; P = 0.001).ConclusionPatients with CDI presented with a significantly higher rate of colorectal anastomosis leakage prior to ileostomy closure.

Association between antiulcer agents and Clostridioides difficile infection in patients receiving antibiotics: A retrospective cohort study using the diagnosis procedure combination database in Japan

To evaluate baseline risk for hospital onset Clostridioides difficile infection (HO-CDI) and the association with the use of antiulcer agents among patients undergoing antibiotic therapy in Japan. We conducted a retrospective cohort study using Japanese Diagnosis Procedure Combination database. Between July 2018 and January 2019, patients aged ≥18 years were included if they started antibiotics within two days of hospital admission. We defined exposure as proton pump inhibitors or histamine 2 receptor antagonists starting from day 2 to day 4 and the primary outcome as HO-CDI within 30 days. We performed multivariable analyses with complete cases using the propensity score (inverse probability treatment weighting [IPTW]) and several sensitivity analyses. In total, 87,137 patients were included. The median age was 78 years; 52.0% were men, and 23.6% received antiulcer agents. Within 30 days of admission, HO-CDI were observed in 0.41% and 0.26% of the antiulcer agent and control groups, respectively. IPTW revealed a positive association between antiulcer agents and HO-CDI (adjusted odds ratio, 1.33; 95% confidence interval [CI]: 1.13, 1.56). In the IPTW method, the risk difference was smaller (0.09%, 95% CI: 0.04%, 0.15%). The use of antiulcer agents in patients with antibiotics was associated with HO-CDI in Japan. However, the baseline risk and the difference in HO-CDI event rates were small; thus, as per several clinical practice guidelines, it is important to monitor antiulcer agent use and discontinue unnecessary use. The baseline risk should be considered when clinically evaluating the association between antiulcer agents and HO-CDI.

Transfer of FRozen Encapsulated multi-donor Stool filtrate for active ulcerative Colitis (FRESCO): study protocol for a prospective, multicenter, double-blind, randomized, controlled trial

BackgroundUlcerative colitis (UC) is a chronic inflammatory bowel disease with significant morbidity and mortality. Although the precise cause remains unknown, disturbances in the intestinal microbial community have been linked to its pathogenesis. Randomized controlled trials in UC and relapsing Clostridioides difficile infection (CDI) have established fecal microbiota (FM) transfer (FMT) as an effective therapy. In this context, preliminary results indicated that the transfer of sterile fecal microbiota filtrates (<0.2 μm; FMF, FMFT) of donor stool also drives gastrointestinal microbiota changes and eliminates symptoms in CDI patients. However, along with the success of FMT, regulatory agencies issued safety alerts following reports of serious adverse events due to transmission of enteric pathogens through FMT. To reduce this risk, we established an extensive test protocol for our donors and quarantine regulations for the produced capsules, but alternative concepts are desirable.MethodsOur project is a randomized, controlled, longitudinal, prospective, three-arm, multicenter, double-blind study to determine the safety and efficacy of repeated long-term, multi-donor FM or FMF transfers compared to placebo using oral, frozen capsules in 174 randomized patients with mild to moderate active UC. The primary outcome will be clinical remission at week 12.DiscussionThis proposal aims to examine (a) the efficacy of encapsulated transfer of FM and FMF as a therapy for mild to moderate UC, (b) the short- and long-term safety of FMT and FMFT in patients with UC, and (c) the microbial and immunologic changes that occur after FMT and FMFT to help understand how and why it affects inflammatory bowel disease.Trial registrationClinicalTrials.govNCT03843385. DRKS (Deutsches Register für Klinische Studien) DRKS00020471