Irritable Bowel Syndrome Severity Scoring System Research Articles

Gastrointestinal symptoms and dietary intake of patients with irritable bowel syndrome following a low FODMAP diet

High FODMAP (fermentable oligo-, di, monosaccharides and polyols) foods have been linked with worsening symptoms of IBS patients. The aim was to compare gastrointestinal symptoms and dietary intake of patients with irritable bowel syndrome following a low FODMAP diet, with or without individual nutrition therapy. A total of 54 patients that met Rome IV criteria for IBS were randomized into two groups, guided group (individual nutrition therapy, n=28) and self-management group (learned about low FODMAP diet online, n=26). Both groups followed low FODMAP diet for 4 weeks. Four-day food records were used to assess dietary intake. Symptoms were assessed by the IBS-severity scoring system (ISB-SSS). The number of subjects who did not complete the study was 13, thereof five in the nutrition therapy and eight in the self-management group, leaving 23 and 18 subjects available for analysis, respectively. Symptoms declined from baseline to endpoint in both groups, by 183±101 points on average in the group receiving nutrition therapy (p< 0.001) and 132±110 points in the self-management group (p< 0.001), with no difference between groups. At baseline, about 80% of meals in both groups contained food high in FODMAP's. The corresponding proportion was 9% and 36% in week 3 in the nutrition therapy and self-management group, respectively (p< 0.001). Both groups experienced relieve of symptoms, but compliance to the low FODMAP diet was better in the group receiving individual nutrition therapy compared with the group who only received instructions on how to learn about low FODMAP diet online.

Nutritional safety and status following a 12-week strict low FODMAP diet in patients with irritable bowel syndrome.

A low FODMAP diet (LFD) is an established dietary treatment for patients with irritable bowel syndrome (IBS). However, knowledge on the extended effects of the restriction phase regarding nutrient intake, symptom severity, and quality of life (QoL) is sparse. Therefore, our objectives were to evaluate the safety of a dietitian-led 12-week strict LFD on measures of blood biochemistry, nutritional status, symptom severity, and QoL. In this open-label dietitian-led 12-week strict LFD intervention for IBS patients with predominantly diarrhea or mixed stool pattern (IBS-D/-M), we collected data on diet intake (3-day dietary record), overnight fasting routine blood samples, body weight, IBS symptoms (IBS Severity Scoring System (IBS-SSS)), and IBS-related QoL (IBS-QoL) at baseline and after 12 weeks. Thirty-six participants completed the 12-week follow-up (mean age: 37 years, 67% women, IBS-SSS: 242 (101)). All blood parameters measured were within established reference values at both time points. We found no change in intake of macro- or micronutrients, but several micronutrients were below the recommendations both before and after 12 weeks. BMI slightly decreased, primarily driven by participants with BMI >25 (p < 0.005). QoL improved among most subdomains (p ≤ 0.002), except food avoidance and social reaction. An extended dietitian-guided LFD (12 weeks) is not inferior to the participants' baseline diet, since no clinically meaningful changes in nutritionally related blood samples and no changes in macro- or micronutrient intake were observed. However, the intake of several nutrients was below the recommendations at both time points indicating low diet quality.

A low FODMAP diet plus traditional dietary advice versus a low-carbohydrate diet versus pharmacological treatment in irritable bowel syndrome (CARIBS): a single-centre, single-blind, randomised controlled trial

Dietary advice and medical treatments are recommended to patients with irritable bowel syndrome (IBS). Studies have not yet compared the efficacy of dietary treatment with pharmacological treatment targeting the predominant IBS symptom. We therefore aimed to compare the effects of two restrictive dietary treatment options versus optimised medical treatment in people with IBS. This single-centre, single-blind, randomised controlled trial was conducted in a specialised outpatient clinic at the Sahlgrenska University Hospital, Gothenburg, Sweden. Participants (aged ≥18 years) with moderate-to-severe IBS (Rome IV; IBS Severity Scoring System [IBS-SSS] ≥175) and no other serious diseases or food allergies were randomly assigned (1:1:1) by web-based randomisation to receive a diet low in fermentable oligosaccharides, disaccharides, monosaccharides, and polyols (FODMAPs) plus traditional IBS dietary advice recommended by the UK National Institute for Health and Care Excellence (hereafter the LFTD diet), a fibre-optimised diet low in total carbohydrates and high in protein and fat (hereafter the low-carbohydrate diet), or optimised medical treatment based on predominant IBS symptom. Participants were masked to the names of the diets, but the pharmacological treatment was open-label. The intervention lasted 4 weeks, after which time participants in the dietary interventions were unmasked to their diets and encouraged to continue during 6 months' follow-up, participants in the LFTD group were instructed on how to reintroduce FODMAPs, and participants receiving pharmacological treatment were offered diet counselling and to continue with their medication. The primary endpoint was the proportion of participants who responded to the 4-week intervention, defined as a reduction of 50 or more in IBS-SSS relative to baseline, and was analysed per modified intention-to-treat (ie, all participants who started the intervention). Safety was analysed in the modified intention-to-treat population. This trial is registered with ClinicalTrials.gov, NCT02970591, and is complete. Between Jan 24, 2017, and Sept 2, 2021, 1104 participants were assessed for eligibility and 304 were randomly assigned. Ten participants did not receive their intervention after randomisation and thus 294 participants were included in the modified intention-to-treat population (96 assigned to the LFTD diet, 97 to the low-carbohydrate diet, and 101 to optimised medical treatment). 241 (82%) of 294 participants were women and 53 (18%) were men and the mean age was 38 (SD 13). After 4 weeks, 73 (76%) of 96 participants in the LFTD diet group, 69 (71%) of 97 participants in the low-carbohydrate diet group, and 59 (58%) of 101 participants in the optimised medical treatment group had a reduction of 50 or more in IBS-SSS compared with baseline, with a significant difference between the groups (p=0·023). 91 (95%) of 96 participants completed 4 weeks in the LFTD group, 92 (95%) of 97 completed 4 weeks in the low-carbohydrate group, and 91 (90%) of 101 completed 4 weeks in the optimised medical treatment group. Two individuals in each of the intervention groups stated that adverse events were the reason for discontinuing the 4-week intervention. Five (5%) of 91 participants in the optimised medical treatment group stopped treatment prematurely due to side-effects. No serious adverse events or treatment-related deaths occurred. Two 4-week dietary interventions and optimised medical treatment reduced the severity of IBS symptoms, with a larger effect size in the diet groups. Dietary interventions might be considered as an initial treatment for patients with IBS. Research is needed to enable personalised treatment strategies. The Healthcare Board Region Västra Götaland, the Swedish Research Council, the Swedish Research Council for Health, Working Life and Welfare, AFA Insurance, grants from the Swedish state, the Wilhelm and Martina Lundgren Science Foundation, Skandia, the Dietary Science Foundation, and the Nanna Swartz Foundation.

The relationship between the low food chemical diet and symptoms in irritable bowel syndrome: a cross-sectional survey

Dietary therapies have revolutionised treatment for irritable bowel syndrome (IBS). However, response rates to the diet with the highest evidence of efficacy (the low FODMAP diet) remain at 50-75%, suggesting other potential drivers of symptom onset. A low food chemical elimination-rechallenge diet targeting bioactive food chemicals (including salicylates, amines, glutamate and other additives), is commonly applied in Australia in patients exhibiting both gastrointestinal and extra-intestinal symptoms. One key food chemical, salicylate, has been shown to elicit symptoms in IBS patients with aspirin-sensitivity(1), and 77% of IBS patients have reported amine-rich foods trigger symptoms(2). However, data supporting the full low chemical diet is scant, and safety concerns exist due to its restrictive nature potentially causing nutritional deficiencies and disordered eating. This cross-sectional survey aimed to evaluate the frequency of co-existing extra-intestinal symptoms, as well as explore patient perceptions and use of the low chemical diet in those with IBS and healthy controls. Participants with IBS (IBS-Severity Scoring System (IBS-SSS) &gt;75), and healthy controls (not meeting Rome IV and IBS-SSS ≤75) were recruited via online advertisement. Validated questionnaires were used to assess gastrointestinal symptoms (IBS-SSS), extraintestinal symptoms (extended PHQ-12), nutrient (Comprehensive Nutritional Assessment Tool) and food additive intake (IBD-Food additive questionnaire). Additional questionnaires assessed use of dietary therapies with specific focus on food chemicals. Data was analysed using independent samples t-test and chi-square test. 204 IBS (Total IBS-SSS, 277 ± 79) and 22 healthy controls (36 ± 28, p&lt;0.01) completed the study. IBS participants were more likely to report extra-intestinal symptoms including headaches (p&lt;0.01), migraines (p = 0.03), fatigue (p&lt;0.01), difficulty sleeping (p = 0.03), rhinitis (p = 0.02), urticaria (p = 0.04) and mood disturbance (p&lt;0.01). IBS participants were more likely to report at least one food chemical as a trigger for gastrointestinal (38% vs 13%, p = 0.03) and/or extra-intestinal (30% vs 9%, p = 0.04) symptoms. In the IBS group, the most common suspected dietary triggers for gastrointestinal symptoms were salicylates (19%) followed by MSG (17%) and artificial colours (14%); while for extra-intestinal symptoms, MSG (15%) was most common, followed by amines (14%), and sulphites (12%). There was no significant difference in consumption of ultra-processed, additive containing foods. Twenty-one (10%) IBS participants were following a low chemical diet, with dietary advice provided by a dietitian (n = 13), general practitioner (n = 6), gastroenterologist (n = 6), naturopath (n = 3), family/friend (n = 4) and/or the diet was self-initiated (n = 7). Fourteen of the 21 (67%) reported following both a low food chemical and low FODMAP diet. Patients with IBS are more likely to report extra-intestinal symptoms compared to healthy controls. Despite limited evidence, a low food chemical diet is utilised to manage both gastrointestinal and extra-intestinal symptoms. Of concern, many respondents following a low food chemical diet reported also following a low FODMAP diet, which may have implications for nutritional adequacy.

THE MOST COMMON DISORDERS OF THE INTESTINE-BRAIN AXIS IN PATIENTS WITH GLUTEN-DEPENDENT DISEASES ON THE BACKGROUND OF MEDICAL NUTRITION AND THE POSSIBILITY OF THEIR CORRECTION

Background. At least 20% of people with celiac disease (CD) continue to experience symptoms during a gluten-free diet (GFD). Other estimates indicate that more than one-third of individuals with celiac disease have symptoms similar to those seen in disorders of gut-brain interaction (particularly irritable bowel syndrome (IBS) or functional dyspepsia). Similarly, approximately 25% of individuals with non-celiac gluten sensitivity (NCGS) continue to have unexplained complaints during a GFD.&#x0D; Aim: To investigate and evaluate the potential correction of IBS-like symptoms in patients with celiac disease and NCGS adhering to a GFD using a probiotic.&#x0D; Materials and Methods. The study included 42 adult participants, of whom 22 (52.38%) had celiac disease, and 20 (47.62%) had NCGS. Patient surveys, using the Irritable Bowel Syndrome Severity Scoring System (IBS-SSS), were conducted in April-May 2023 before and after the administration of a multi-strain probiotic containing Lactobacillus plantarum CECT7484, Lactobacillus plantarum CECT7485, Pediococcus acidilactici CECT7483 - at least 3x10⁹ CFU. The duration of the probiotic treatment was 30 days. The data obtained were processed using the "Statistica 10.0" software package.&#x0D; Results. After a 30-day course of probiotic intake, a significant reduction in the severity of IBS-like symptoms (p=0.00005) was observed in the majority of patients with gluten-sensitive pathology according to the IBS-SSS questionnaire: symptom reduction was noted in 29 patients (69%), no change in condition in 7 patients (17%), worsening of the condition and increased severity of complaints in 6 patients (14%). The severity of IBS-like symptoms determined the treatment response: in patients with IBS and more pronounced symptoms, the probiotic showed significantly greater effectiveness, particularly in cases with pronounced complaints (bloating, constipation, diarrhea, abdominal pain) (p=0.009376) and in moderate cases (p=0.000379). The probiotic most effectively influenced bloating in both patient groups (p=0.003699).&#x0D; Conclusion. The combination of two strains of Lactobacillus plantarum (CECT7484 and CECT7485) and one strain of Pediococcus acidilactici (CECT7483) can be effectively used to correct IBS-like complaints in patients with celiac disease and NCGS who have complaints despite adhering to a GFD.

Probiotics plus vitamin D in irritable bowel syndrome: a prospective multicentric non-interventional study.

Patients with irritable bowel syndrome (IBS) experience recurrent symptoms and anxiety disorders that significantly impact their quality of life (QoL). The aim of the study was to assess in daily practice the benefit of the combination of three probiotic strains (Lactobacillus plantarum CETC 7484 and CETC 7485; Pediococcus acidilactici CECT 7483) plus vitamin D in patients with diarrhea-predominant IBS (IBS-D) or IBS with mixed bowel movements (IBS-M). This was a prospective, multicenter, non-interventional study in adult patients with IBS-D or IBS-M (Rome IV criteria) followed by private-practice gastroenterologists. Patients received daily one sachet of a combination of probiotics (3×109 CFU) and vitamin D (10 μg) for 42 days. The primary endpoint was the responder rate at D42 (≥50% and/or ≥100-point decrease of IBS-Severity Scoring System; IBS-SSS). Gut-related anxiety was measured with the Visceral Sensitivity Index (VSI). The full analysis set population included 246 patients (mean age, 51.2±15.4 years; women, 73.2%; IBS-D, 56.1%; IBS-M, 43.9%). At D42, among the 89 patients with evaluable data, the responder rate was 62.9% with a mean decrease of IBS-SSS of 146.6±125.9 (P<0.0001). Changes of IBS-SSS were significantly correlated with changes of IBS-QoL (r=-0.78; P<0.0001), HAD-anxiety (r=0.46; P<0.0001), HAD-depression (r=0.61; P<0.001) and VSI (r=0.74; P<0.0001). These real-life results are in line with a previous randomized clinical trial demonstrating the benefits of this combination in IBS-D and IBS-M. Symptom relief was associated with improvement of IBS-QoL, anxiety, depression and specifically gut-related anxiety.

Palmitoylethanolamide and polydatin in pediatric irritable bowel syndrome: A multicentric randomized controlled trial

ObjectiveThis study aimed to evaluate the efficacy and safety of co-micronized palmitoylethanolamide (PEA)/polydatin (PD) in the treatment of abdominal pain symptoms in pediatric patients with irritable bowel syndrome (IBS). MethodsThis was a multicenter trial conducted at three Italian pediatric gastroenterology centers, employing a double-blind, placebo-controlled, parallel-arm design. Participants were ages 10 to 17 y and met Rome IV criteria for pediatric IBS. They were randomly allocated to receive either co-micronized PEA/PD or placebo, administered three times daily in a 1:1 ratio, over a 12-wk period. The study assessed baseline severity using the IBS-Severity Scoring System (IBS-SSS) at enrollment and after 4, 8, and 12 wk of treatment. Abdominal pain frequency was assessed on a scale from 1 to 7 d/wk, while stool consistency was classified using the Bristol Stool Scale (BSS) to categorize various IBS subtypes. The primary outcome was the percentage of patients who achieved complete remission, defined as IBS-SSS score <75 points after 12 wk of therapy. ResultsThe study involved 70 children with IBS. Of the participants, 34 received co-micronized PEA/PD, and 36 received a placebo. As compared with the placebo group, the co-micronized therapy group had significantly more patients achieving complete remission after 12 wk (P = 0.015), with particular benefit in the IBS-diarrhea subtype (P = 0.01). The treatment group also experienced a significant reduction in abdominal pain intensity and frequency compared with the placebo group. No adverse events were recorded during the study period. ConclusionsCo-micronized PEA/PD is a safe and effective treatment to treat abdominal pain symptoms in pediatric IBS.

Exploration of differential responses to FODMAPs and gluten in people with irritable bowel syndrome- a double-blind randomized cross-over challenge study

IntroductionThere is large variation in response to diet in irritable bowel syndrome (IBS) and determinants for differential response are poorly understood.ObjectivesOur aim was to investigate differential clinical and molecular responses to provocation with fermentable oligo-, di-, monosaccharides, and polyols (FODMAPs) and gluten in individuals with IBS.MethodsData were used from a crossover study with week-long interventions with either FODMAPs, gluten or placebo. The study also included a rapid provocation test. Molecular data consisted of fecal microbiota, short chain fatty acids, and untargeted plasma metabolomics. IBS symptoms were evaluated with the IBS severity scoring system. IBS symptoms were modelled against molecular and baseline questionnaire data, using Random Forest (RF; regression and clustering), Parallel Factor Analysis (PARAFAC), and univariate methods.ResultsRegression and classification RF models were in general of low predictive power (Q2 ≤ 0.22, classification rate < 0.73). Out of 864 clustering models, only 2 had significant associations to clusters (0.69 < CR < 0.73, p < 0.05), but with no associations to baseline clinical measures. Similarly, PARAFAC revealed no clear association between metabolome data and IBS symptoms.ConclusionDifferential IBS responses to FODMAPs or gluten exposures could not be explained from clinical and molecular data despite extensive exploration with different data analytical approaches. The trial is registered at www.clinicaltrials.gov as NCT03653689 31/08/2018.

Gut microbiota composition is altered in postural orthostatic tachycardia syndrome and post-acute COVID-19 syndrome

Postural Orthostatic Tachycardia Syndrome (POTS) reflects an autonomic dysfunction, which can occur as a complication to COVID-19. Our aim was to examine gastrointestinal symptoms and gut microbiota composition in patients with POTS and post-acute COVID-19 syndrome (PACS), compared with controls. POTS patients (n = 27), PACS patients (n = 32) and controls (n = 39) delivered fecal samples and completed a 4-day food diary, irritable bowel syndrome-severity scoring system (IBS-SSS), and visual analog scale for IBS (VAS-IBS). A total of 98 DNA aliquots were sequenced to an average depth of 28.3 million (M) read pairs (Illumina 2 × 150 PE) per sample. Diversity and taxonomic levels of the microbiome, as well as functional abundances were calculated for POTS and PACS groups, then compared with controls. There were several differences in taxonomic composition between POTS and controls, whereas only the abundance of Ascomycota and Firmicutes differed between PACS and controls. The clinical variables total IBS-SSS, fatigue, and bloating and flatulence significantly correlated with multiple individual taxa abundances, alpha diversity, and functional abundances. We conclude that POTS, and to a less extent PACS, are associated with differences in gut microbiota composition in diversity and at several taxonomic levels. Clinical symptoms are correlated with both alpha diversity and taxonomic and functional abundances.

Translation, validation, and first application of the Greek version of an irritable bowel syndrome severity scoring system.

The Irritable Bowel Syndrome Severity Scoring System (IBS-SSS) is a self-administered questionnaire that categorizes patients according to symptom severity. We aimed to translate and adapt the English IBS-SSS, validate the Greek version, and detect factors predictive of IBS severity. The original English version was obtained from the Rome Foundation, and the final Greek version arose through a process of translation, comprehensibility evaluation and back-translation. The 141 participants enlisted in the study were enrolled from 2 tertiary hospitals and were divided into 2 groups (98 patients and 43 healthy volunteers). We evaluated the questionnaire properties based on COSMIN criteria. The recruited patients reported either diarrhea-predominant (34.7%), constipation-predominant (28.6%), or mixed subtype (36.7%) IBS. No significant variations were found regarding the frequency and intensity of abdominal pain and flatulence among the 3 IBS subtypes. Severity scores among healthy volunteers were significantly lower compared to IBS patients, irrespective of their disease subtype (P<0.001). The Cronbach coefficient (α) was calculated at 0.953, suggesting high inter-item internal consistency. The intraclass correlation coefficient was calculated and found to be high, suggesting good responsiveness of the questionnaire. Two-way MANOVA evaluation showed that demographic variables (age, family status, body mass index [BMI], smoking, and alcohol consumption) in the Greek population affect the IBS-SSS score and syndrome severity. The Greek version of IBS-SSS is a reliable, valid and responsive tool for assessing Greek IBS patients' symptom severity. Older age, smoking, alcohol use and higher BMI are indicative of greater symptom severity.

Effectiveness of an amino acid beverage formulation in diarrhea-predominant irritable bowel syndrome: A pragmatic real-world study.

Amino-acid based medical foods have shown promise in alleviating symptoms of drug induced gastrointestinal side effects; particularly, diarrhea-predominant symptoms. Irritable bowel syndrome (IBS) is a gastrointestinal disorder that affects up to 9% of people globally, with diarrhea predominant IBS (IBS-D) being the most prevalent subtype. Further trials are needed to explore potential added benefits when integrated into standard care for IBS-D. To assess the effectiveness of an amino acid-based medical food as an adjunct to standard of care for adults with IBS-D. This is a pragmatic, real world, open label, single arm study comparing a 2-week baseline assessment to a 2-week intervention period. One hundred adults, aged 18 to 65 years, with IBS-D, according to Rome IV criteria, were enrolled after completing a 2-week baseline assessment period and received a 2-week supply of an amino acid based medical food which was consumed at home twice daily on top of their standard of care. The primary outcome was an assessment of tolerability after 2-weeks of consumption, while secondary outcomes included changes in stool consistency (Bristol Stool Form Scale), severity of abdominal pain & discomfort, symptoms of urgency, Global Improvement Survey (GIS), and the IBS severity scoring system (IBS-SSS). The test product was well-tolerated as each participant successfully completed the full 14-day trial, and there were no instances of dropouts or discontinuation of the study product reported. Forty percent of participants achieved a 50% or more reduction in the number of days with type 6-7 bowel movements (IBS-D stool consistency responders). Fifty-three percent of participants achieved a clinically meaningful reduction of 30% in mean weekly pain scores, and 55% experienced the same for mean weekly discomfort scores (IBS-D pain and discomfort responders). Participants experienced a mean -109.4 (95% confidence interval: -130.1, -88.8) point reduction on the IBS-SSS and 52% experienced a minimally clinically important difference of > 95 points. An IBS-SSS category shift from severe to moderate or mild occurred in 69% of participants. For functional symptoms, 76% of participants reported symptom relief on the GIS. The amino acid-based medical food was well-tolerated, when added to the standard of care, and demonstrated improvements in both overall IBS symptom severity and IBS-D symptoms within just 2 wk.

Amitriptyline at Low-Dose and Titrated for Irritable Bowel Syndrome as Second-Line Treatment in primary care (ATLANTIS): a randomised, double-blind, placebo-controlled, phase 3 trial

Most patients with irritable bowel syndrome (IBS) are managed in primary care. When first-line therapies for IBS are ineffective, the UK National Institute for Health and Care Excellence guideline suggests considering low- dose tricyclic antidepressants as second-line treatment, but their effectiveness in primary care is unknown, and they are infrequently prescribed in this setting. This randomised, double-blind, placebo-controlled trial (Amitriptyline at Low-Dose and Titrated for Irritable Bowel Syndrome as Second-Line Treatment [ATLANTIS]) was conducted at 55 general practices in England. Eligible participants were aged 18 years or older, with Rome IV IBS of any subtype, and ongoing symptoms (IBS Severity Scoring System [IBS-SSS] score ≥75 points) despite dietary changes and first-line therapies, a normal full blood count and C-reactive protein, negative coeliac serology, and no evidence of suicidal ideation. Participants were randomly assigned (1:1) to low-dose oral amitriptyline (10 mg once daily) or placebo for 6 months, with dose titration over 3 weeks (up to 30 mg once daily), according to symptoms and tolerability. Participants, their general practitioners, investigators, and the analysis team were all masked to allocation throughout the trial. The primary outcome was the IBS-SSS score at 6 months. Effectiveness analyses were according to intention-to-treat; safety analyses were on all participants who took at least one dose of the trial medication. This trial is registered with the ISRCTN Registry (ISRCTN48075063) and is closed to new participants. Between Oct 18, 2019, and April 11, 2022, 463 participants (mean age 48·5 years [SD 16·1], 315 [68%] female to 148 [32%] male) were randomly allocated to receive low-dose amitriptyline (232) or placebo (231). Intention-to-treat analysis of the primary outcome showed a significant difference in favour of low-dose amitriptyline in IBS-SSS score between groups at 6 months (-27·0, 95% CI -46·9 to -7·10; p=0·0079). 46 (20%) participants discontinued low-dose amitriptyline (30 [13%] due to adverse events), and 59 (26%) discontinued placebo (20 [9%] due to adverse events) before 6 months. There were five serious adverse reactions (two in the amitriptyline group and three in the placebo group), and five serious adverse events unrelated to trial medication. To our knowledge, this is the largest trial of a tricyclic antidepressant in IBS ever conducted. Titrated low-dose amitriptyline was superior to placebo as a second-line treatment for IBS in primary care across multiple outcomes, and was safe and well tolerated. General practitioners should offer low-dose amitriptyline to patients with IBS whose symptoms do not improve with first-line therapies, with appropriate support to guide patient-led dose titration, such as the self-titration document developed for this trial. National Institute for Health and Care Research Health Technology Assessment Programme (grant reference 16/162/01).

An 8-Week Course of Bifidobacterium longum 35624® Is Associated with a Reduction in the Symptoms of Irritable Bowel Syndrome.

Irritable bowel syndrome (IBS) is one of the disorders most frequently diagnosed by gastroenterologists. Probiotics are promising tools for the management of IBS. The objective of the present study was to evaluate the effectiveness and tolerability of a probiotic (Bifidobacterium longum 35624®) in adults (aged 18 or over) with IBS (as defined by the Rome IV criteria). In an open-label, observational, post-market study conducted in Germany, adults with IBS and a prior recommendation for the intake of B. longum 35624® were recruited by family physicians. During the 8-week course of treatment, the study participants filled out a weekly questionnaire that enabled calculation of a total IBS symptom score (TISS, the sum of abdominal pain, bloating, passage of gas, constipation, and diarrhea individual symptom scores) and the well-known IBS severity scoring system (IBS-SSS) score. Thirty-seven patients were included. The course of B. longum 35624® was associated with a significant reduction (43.4%) in the TISS vs. baseline. The mean individual symptom grades for passage of gas and bloating fell significantly from "moderate" at baseline to "very mild to mild" after 8 weeks of treatment, whereas those for abdominal pain and diarrhea fell significantly from "mild to moderate" to "very mild to mild." Over 60% of the participants achieved clinically meaningful reductions in the TISS (> 30%) and the IBS-SSS score (> 50 points). The effectiveness of B. longum 35624® was rated as "good to satisfactory" by study participants and the investigating physicians. One mild adverse event (nausea) was potentially linked to the study treatment. We conclude that an 8-week course of B. longum 35624® was associated with significant, clinically meaningful symptom relief in a typical population of adult patients with IBS.

A Randomised Double Blind Control Trial of Add-on Duloxetine on Symptom Severity and Quality of Life in Irritable Bowel Syndrome: Protocol of a Proof-of- Concept Study

Background: Duloxetine is a selective serotonin and norepinephrine reuptake inhibitor (SNRI), which has been approved in the United States and Europe for the treatment of the major depressive disorder, generalized anxiety disorder, peripheral neuropathy in patients with diabetes and fibromyalgia, but it has not been approved for the treatment of irritable bowel syndrome. In an open-label study on the duloxetine impact on symptoms of irritable bowel syndrome, duloxetine resulted in significant improvement in the severity of pain, the severity of illness, quality of life, anxiety, and disability at work and life, but this study was conducted on small sample size. This study aims to investigate the effectiveness of duloxetine on Symptom Severity And Quality Of Life In Irritable Bowel Syndrome. Methods: A total of 62 patients will be enrolled in the study and will be randomized into two groups (cases and control). Randomisation will be done using a computer generated random number table. Rome IV Criteria will be applied for diagnosis of Irritable Bowel Syndrome. Informed consent will be taken. Severity will be assessed by IBS Severity Scoring System. Screening for psychiatric disorders will be done following a clinical interview. Diagnosis will be confirmed as per ICD-10. Socio-demographic and clinical details of patients will be recorded on the semi-structured proforma. Specified rating scales (IBS-SSS, IBS-QOL) will be applied appropriately. The clinician can change the dosages as per the tolerability within the range. Control group shall receive treatment as usual only. Both the cases and controls will not be given any other psychotropic medications in addition to Duloxetine during the study period. Both cases and controls shall be assessed on the start of the treatment and by 2nd, 4th and 8th week. Drug adverse effects and compliance to treatment will be evaluated every 2 weeks after starting the treatment. Data obtained will be analysed statistically with appropriate statistical tools. The trial has been registered in the Clinical Trials Registry, India (CTRI/2023/04/051948). Result: After the collection of data, statistical analysis will be done by using a computerized statistical program, Statistical Package for Social Sciences. Mean changes in the rating scale scores will be compared after each assessment and between the groups. Conclusion: The findings will help to assess the efficacy of Add-On Duloxetine On Symptom Severity And Quality Of Life In Irritable Bowel Syndrome

Randomised clinical trial: Faecal microbiota transplantation for irritable bowel syndrome with diarrhoea.

Faecal microbiota transplantation (FMT) has been shown to improve symptoms in a proportion of patients with irritable bowel syndrome (IBS). We performed a randomised trial to assess the efficacy of FMT in patients with IBS. We randomised 56 patients with diarrhoea-predominant IBS 1:1 to FMT or placebo via the duodenal route at baseline and week 4. The primary outcome was > 50 points decrease in IBS severity scoring system (IBS-SSS) score at week 12. Secondary outcomes were improvement in bloating and change in gut microbiota at week 12. After 12-week follow-up, those in the placebo group were assigned to receive open-label FMT. At week 12, 57.1% in the FMT group and 46.4% in the placebo group achieved the primary endpoint (p = 0.42). More patients receiving FMT than placebo had improvement in bloating (72% vs 30%; p = 0.005). In an open-label extension, 65.2% and 82.4% of patients achieved, respectively, the primary endpoint and improvement in bloating. Faecal microbiome of patients in the FMT group showed a reduction in bacteria like Ruminococcus gnavus and enrichment of bacteria such as Lawsonibacter at week 12, while no change in the placebo group. Functional analyses showed that the hydrogen sulphide-producing pathway decreased in patients who had FMT (p < 0.05) accompanied by a reduction in contributing bacteria. There were no serious adverse events related to FMT. FMT performed twice at an interval of four weeks did not significantly reduce IBS-SSS score. However, more patients had improvement in abdominal bloating, which was associated with a reduction in hydrogen sulphide-producing bacteria. (ClinicalTrials.gov NCT03125564).

Washed microbiota transplantation targeting both gastrointestinal and extraintestinal symptoms in patients with irritable bowel syndrome

ObjectiveFecal microbiota transplantation (FMT) has been reported with the treatment potential for irritable bowel syndrome (IBS). However, the knowledge of its effect on extraintestinal symptoms of IBS is limited. This study aimed to evaluate the efficacy of the improved methodology of FMT, washed microbiota transplantation (WMT), on sleep disturbances, and psychological and gastrointestinal symptoms among patients with IBS. MethodsThis was a prospective observational study involving patients with IBS who underwent WMT. The Pittsburgh Sleep Quality Index (PSQI) was used to assess sleep quality. The Gastrointestinal Symptom Rating Scale (GSRS) and IBS Severity Scoring System (IBS-SSS) were used to evaluate gastrointestinal symptoms and IBS severity, respectively. The Self-rating Depression Scale (SDS) and Self-rating Anxiety Scale (SAS) were used to evaluate depression and anxiety, respectively. All the symptoms were evaluated at baseline and one month after WMT. A multiple logistic regression model was used to determine the predictive factors of sleep improvement one month after WMT. ResultsSeventy-three patients with IBS were included in the study. Sleep quality (Z = −4.211, P < 0.001), anxiety (Z = −4.775, P < 0.001), depression (Z = −4.610, P < 0.001), gastrointestinal symptoms (Z = −5.364, P < 0.001), and IBS severity (Z = −6.468, P < 0.001) significantly improved one month after WMT in all patients. The scores of the five components of PSQI including subjective sleep quality, sleep latency, sleep duration, habitual sleep efficiency, and sleep disturbances decreased in 52 patients with poor sleep quality (all P < 0.05). Baseline sleep duration scores were identified as an independent predictive factor of sleep improvement one month after WMT in patients with poor sleep quality (OR 2.180 [95% CI = 1.017–4.673]; P = 0.045). Patients that experienced sleep improvement demonstrated greater alleviation in depression (Z = −1.990, P = 0.047) and IBS severity (Z = −2.486, P = 0.013) compared with patients without sleep improvement. ConclusionThis study suggested that WMT might be a promising therapy for patients with IBS, especially those with comorbid sleep and psychological disorders.

The Efficacy and Safety of Single-Strain Probiotic Formulations Containing Bifidobacterium lactis or Bacillus coagulans in Adult Patients with Irritable Bowel Syndrome-A Randomized Double-Blind Placebo-Controlled Three-Arm Interventional Trial.

Probiotics offer a potential new therapeutic approach for irritable bowel syndrome (IBS), but current results are still controversial. The aim of this study was to assess the efficacy and safety of single-strain probiotic formulations in adult IBS patients and to compare the effects of Bifidobacterium lactis NORDBIOTIC™ BI040 (DSM 33812/34614) and Bacillus coagulans NORDBIOTIC™ BC300 (DSM 33836) in a prospective three-arm interventional randomized double-blind placebo-controlled clinical trial. The study included 123 IBS subjects diagnosed according to the Rome IV criteria. The primary outcomes were changes in symptom severity and symptom improvement as assessed using the IBS Severity Scoring System (IBS-SSS) after 4, 8, and 12 weeks of intervention and after 4 weeks of follow-up. Secondary outcomes included the assessment of individual IBS symptoms and the occurrence of adverse events. During the 12-week intervention, IBS-SSS scores significantly decreased (p-values < 0.001) in the study groups but differences between the interventional and placebo groups did not reach statistical significance. However, at the 16th week of follow-up, a significant improvement in the total IBS-SSS score in comparison to the placebo group (20.5%) was found in 43.8% and 52.9% of the Bifidobacterium lactis (p = 0.038, OR 3.0, [95% CI 1.1-8.6]) and the Bacillus coagulans (p = 0.005, OR 4.6 [95% CI 1.5-12.2]) groups, respectively. Bifidobacterium lactis had a beneficial effect on the intensity and frequency of pain, whereas Bacillus coagulans decreased the bowel dissatisfaction. Both strains increased the percentage of patients with normal stool consistency, but only Bifidobacterium lactis induced a decrease in the number of patients with constipation after 6 weeks of supplementation. Both probiotic strains were well tolerated, without differences in the occurrence of adverse events between groups. In conclusion, single-strain supplementation was safe and efficient in IBS patients but showed a different range of effects. Bifidobacterium lactis BI040 primarily reduced the frequency and intensity of pain, while Bacillus coagulans BC300 increased bowel satisfaction [ClinicalTrials.gov NCT05064930].

Feasibility, and barriers to use escitalopram in functional gastrointestinal disorders.

Background and study aims: The feasibility and barriars of escitalopram use in patients with functional gastrointestinal disorders (FGIDs) are still debated. We aimed to evaluate the feasibility, safety and efficacy and barriars of escitalopram use in managing FGIDs in the Saudi population. Patients and Methods: We included 51 patients who received escitalopram for irritable bowel syndrome (n = 26), functional heartburn (n = 10), globus sensation (n = 10) or combined disorders (n = 5). We used an irritable bowel syndrome-severity scoring system IBS-SSS), GerdQ questionnaire and Glasgow Edinburg Throat Scale (GETS) to assess disease severity change before and after treatment. Results: The median age was 33 years (25th- 75th percentiles: 29-47), and 26 (50.98%) were males. Forty-one patients experienced side effects (80.39%), but most side effects were mild. The most common side effects were drowsiness/fatigue/dizziness (54.9%), xerostomia (23.53%), nausea/vomiting (21.57%) and weight gain (17.65%). IBS-SSS was 375 (255-430) and 90 (58-205) before and after treatment, respectively (p < 0.001). GerdQ score was 12 (10-13) before treatment and 7 (6-10) after treatment (p = 0.001). GETS score before treatment was 32.5 (21-46) and after treatment became 22 (13-31) (p = 0.002). Thirty-five patients refused to take the medications, and seven patients discontinued the medication. Possible causes of the poor compliance were fear of the medications and not being convinced of taking psychiatric medications for functional disorders (n = 15). Conclusion: Escitalopram could be a safe and effective treatment for functional gastrointestinal disorders. Targeting and managing factors leading to poor compliance could further improve the treatment outcome.

Impact of auricular percutaneous electrical nerve field stimulation on gut microbiome in adolescents with irritable bowel syndrome: A pilot study.

Percutaneous electrical nerve field stimulation (PENFS) has documented efficacy for irritable bowel syndrome (IBS) via plausible vagal neuromodulation effects. The vagus nerve may affect gut microbiome composition via brain-gut-microbiome signaling. We aimed to investigate gut microbiome alterations by PENFS therapy in adolescent IBS patients. A prospective study of females with IBS aged 11-18 years receiving PENFS therapy for 4 weeks with pre- and post-intervention stool sampling was conducted. Outcome surveys completed pre-therapy, weekly, and post-therapy included IBS-Severity Scoring System (IBS-SSS), Visceral Sensitivity Index (VSI), Functional Disability Inventory (FDI), and the global symptom response scale (SRS). Bacterial DNA was extracted from stool samples followed by 16S rRNA amplification and sequencing. QIIME 2 (version 2022.2) was used for analyses of α and β diversity and differential abundance by group. Twenty females aged 15.6 ± 1.62 years were included. IBS-SSS, VSI, and FDI scores decreased significantly after PENFS therapy (P < 0.0001, P = 0.0003, P = 0.0004, respectively). No intra- or interindividual microbiome changes were noted pre- versus post-therapy or between responders and non-responders. When response was defined by 50-point IBS-SSS score reduction, α diversity was higher in responders compared with non-responders at week 4 (P = 0.033). There was higher abundance of Blautia in excellent responders versus non-responders. There were no substantial microbial diversity alterations with PENFS. Subjects with excellent therapeutic response showed an enrichment of relative abundance of Blautia, which may indicate that patients with specific microbial signature have a more favorable response to PENFS.

Disordered eating and eating competence in members of online irritable bowel syndrome support groups.

This study seeks to evaluate eating competence and disordered eating likelihood among members of online support groups for irritable bowel syndrome (IBS) and determine whether eating competence and disordered eating likelihood varies according to IBS symptom severity and subtype. This cross-sectional study is based on an anonymous survey conducted from August to September 2021. Adults with IBS (N = 225) were recruited from online and social media IBS support forums. IBS symptom severity was assessed using the validated IBS Severity Scoring System (IBS-SSS), likelihood of disordered eating was assessed using the validated Eating Attitudes Test (EAT-26), and eating competence was assessed using the validated Satter Eating Competence Inventory (ecSI 2.0™). Multiple linear regression was used to predict EAT-26 total score from IBS-SSS score, age, and IBS subtype. ANOVAs were used to examine the relationships between IBS severity level, IBS subtype, and ecSI 2.0™ total score. Eating competence among the sample was low at 17% while 27% was classified as likely or very likely disordered eating. IBS severity was positively associated with EAT-26 score (p = 0.011) and ecSI 2.0™ score was significantly lower in the severe IBS group compared to the moderate IBS group (p = 0.016). No relationship was detected between IBS subtype and EAT-26 or ecSI 2.0™ scores. IBS severity was positively associated with disordered eating likelihood and negatively associated with eating competence. This sheds light on the importance of assessing eating competence and screening for disordered eating prior to selecting therapies for patients with IBS, particularly in females with severe symptoms.