AGA Clinical Practice Guideline on Fecal Microbiota-Based Therapies for Select Gastrointestinal Diseases.

BACKGROUND & AIMS: Fecal microbiota-based therapies include conventional fecal microbiota transplant and US Food and Drug Administration-approved therapies, fecal microbiota live-jslm and fecal microbiota spores live-brpk. The American Gastroenterological Association (AGA) developed this guideline to provide recommendations on the use of fecal microbiota-based therapies in adults with recurrent Clostridioides difficile infection; severe to fulminant C difficile infection; inflammatory bowel diseases, including pouchitis; and irritable bowel syndrome. METHODS: The guideline was developed using the GRADE (Grading of Recommendations, Assessment, Development, and Evaluation) framework to prioritize clinical questions, identify patient-centered outcomes, and conduct an evidence synthesis. The guideline panel used the Evidence-to-Decision framework to develop recommendations for the use of fecal microbiota-based therapies in the specified gastrointestinal conditions and provided implementation considerations for clinical practice. RESULTS: The guideline panel made 7 recommendations. In immunocompetent adults with recurrent C difficile infection, the AGA suggests select use of fecal microbiota-based therapies on completion of standard of care antibiotics to prevent recurrence. In mildly or moderately immunocompromised adults with recurrent C difficile infection, the AGA suggests select use of conventional fecal microbiota transplant. In severely immunocompromised adults, the AGA suggests against the use of any fecal microbiota-based therapies to prevent recurrent C difficile. In adults hospitalized with severe or fulminant C difficile not responding to standard of care antibiotics, the AGA suggests select use of conventional fecal microbiota transplant. The AGA suggests against the use of conventional fecal microbiota transplant as treatment for inflammatory bowel diseases or irritable bowel syndrome, except in the context of clinical trials. CONCLUSIONS: Fecal microbiota-based therapies are effective therapy to prevent recurrent C difficile in select patients. Conventional fecal microbiota transplant is an adjuvant treatment for select adults hospitalized with severe or fulminant C difficile infection not responding to standard of care antibiotics. Fecal microbiota transplant cannot yet be recommended in other gastrointestinal conditions.

Systematic Review and Meta-analysis: Efficacy of Mesalamine in Irritable Bowel Syndrome.

BACKGROUND & AIMS: Some patients with irritable bowel syndrome (IBS) demonstrate low-grade inflammation in the intestine. Mesalamine, which has anti-inflammatory effects, may be an efficacious treatment for IBS, but studies are conflicting. We conducted a systematic review and meta-analysis to assess efficacy and safety of mesalamine in IBS. METHODS: We searched the medical literature up to September 14, 2022, to identify randomized controlled trials (RCTs) of mesalamine in IBS. We judged efficacy and safety using dichotomous assessments of effect on global IBS symptoms, abdominal pain, bowel habit or stool frequency, and occurrence of any adverse event. We pooled data using a random effects model, with efficacy and safety reported as pooled relative risks (RRs) with 95% confidence intervals (CIs). RESULTS: We identified 8 eligible RCTs (820 patients). Mesalamine was more efficacious than placebo for global IBS symptoms (RR of global symptoms not improving, 0.86; 95% CI, 0.79-0.95; number needed to treat = 10; 95% CI, 6-27), but not for abdominal pain or bowel habit or stool frequency. Subgroup analyses demonstrated efficacy of mesalamine in IBS with diarrhea for global IBS symptoms (RR, 0.88; 95% CI, 0.79-0.99), but not patients with other predominant bowel habits or those with post-infection IBS. Adverse event rates were no higher with mesalamine (RR, 1.20; 95% CI, 0.89-1.63) but were reported in only 5 trials. CONCLUSIONS: Mesalamine may be modestly efficacious for global symptoms in IBS, particularly IBS with diarrhea, but quality of evidence was low. Adequately powered high quality RCTs of mesalamine in IBS are needed.

Development and Current State of Digital Therapeutics for Irritable Bowel Syndrome.

BACKGROUND & AIMS: Irritable bowel syndrome (IBS) is a common, debilitating disorder characterized by abdominal pain and disordered bowel habits. Current pharmacologic treatments often provide incomplete symptom relief and may be poorly tolerated. Furthermore, alleviation of gastrointestinal symptoms does not always translate into improved quality of life for IBS patients. Current treatment guidelines recommend brain-gut behavior therapy (BGBT) in conjunction with other IBS therapies, and, in randomized controlled trials, BGBT has been shown to improve symptoms, patient satisfaction, functioning, and quality of life. Access to BGBT is limited by lack of adequately trained gastrointestinal psychologists, patient time constraints, and cost. Furthermore, clinician knowledge that BGBT is specific, and different from psychotherapy approaches for common mental health disorders, may limit referrals even where available. This review provides an overview of the pathophysiology of IBS, disease burden, unmet therapeutic needs, evidence base of novel digital therapeutics for IBS, and guidance on the introduction and appropriateness of these interventions for patients. METHODS: We searched the literature for available published data relating to the use of novel digital therapeutics to provide cognitive behavioral therapy and gut-directed hypnotherapy in the treatment of irritable bowel syndrome. RESULTS: Clinical trial data support the development and utility of digital therapeutics designed to deliver self-guided cognitive behavioral therapy and hypnotherapy for the treatment of IBS. CONCLUSIONS: BGBTs are effective, guideline-recommended treatments for IBS. Digital therapeutic devices offer accessible, cost-effective treatment options for delivery of adjunctive BGBT for the treatment of IBS. The decision to recommend digital BGBTs should be guided by careful patient assessment that includes mental health screening and risk assessment.

Defecation symptoms in primary health care patients with irritable bowel syndrome.

BACKGROUND: The objectives of the present study were to (a) measure the prevalence of defecation symptoms in IBS, (b) investigate the relationship between stool consistency and defecation symptoms in IBS, and (c) investigate the association of defecation symptoms with health-related quality of life (HRQL) and self-reported stress in patients with IBS cared for in a primary health care setting. METHODS: Ten primary health care centres joined the study. 282 patients with IBS as well as 372 non-IBS controls filled in gastrointestinal symptom diaries prospectively for two weeks as well as the Perceived Stress Scale-14 (PSS14) and the EuroQol barometer to measure perceived stress and HRQL, respectively. RESULTS: Incomplete evacuation was present in 51% vs. 21% of the stools among the IBS patients and the non-IBS controls, respectively. The need to strain during defecation was existing in 41% vs. 33% of the stools for the IBS patients and the non-IBS controls, respectively. Urgency was experienced in 37% of the stools in the IBS patients compared with 18% of the stools in the non-IBS controls. Patients with IBS experienced in a significant higher degree of overlapping symptoms per stool (p < 0.001 to p = 0.007). The occurrence of all defecation symptoms in the same patient was related to decreased HRQL, and increased stress (p = 0.001 to p < 0.001). CONCLUSIONS: An overlap between IBS and symptoms from the anorectal region related to defecation was found in a primary health care population. Defecation symptoms are very common in primary care IBS-patients, it co-occurs with increased self-perceived stress, and decreased HRQL.

Experiences of Irritable Bowel Syndrome Patients in a Virtual Yoga Program: Qualitative Findings from a Clinical Trial.

BACKGROUND AND AIMS: In-person yoga interventions have shown feasibility and effectiveness in improving the outcomes of patients with irritable bowel syndrome (IBS), but experiences in virtual yoga interventions have not been examined. This study aimed to explore patients' experiences of a virtually delivered yoga intervention for IBS. METHODS: An embedded qualitative substudy was included in a randomized controlled trial examining the feasibility and effectiveness of a virtual yoga program among adult patients with IBS. Semi-structured interviews captured participants' past and current experiences, program satisfaction, perceived impact on IBS symptoms and overall physical and mental health, facilitators and barriers to participation, perceptions of social support and supervised learning, and input on improving future programming. Data were coded and analyzed in duplicate using NVivo 12. An analytic template based on the interview guide was developed and thematic analysis identified themes, as well as the relationship between themes and subthemes. RESULTS: Among the 14 participants (all female, mean age 47.7 years), three major themes were identified: (1) positive experience in the yoga program, (2) incorporating yoga into IBS management post-study, and (3) recommendations for program improvement. CONCLUSION: Patients with IBS experience in a virtual yoga program was positive with improvements in physical and mental health outcomes. Considering the barriers and facilitators to participating in an online yoga program along with participant recommendations may improve future intervention design and delivery to increase self-efficacy and confidence among patients with IBS.

A dietitian-led low-FODMAP diet webinar: a pre-post study evaluating its impact on symptoms of irritable bowel syndrome.

BACKGROUND: Evidence suggests that the low fermentable oligo-, di-, mono-saccharides, and polyols (FODMAP) diet improves irritable bowel syndrome (IBS) symptoms when delivered by a dietitian. However, demand for dietetic appointments exceeds supply. Prerecorded webinars are acceptable and cost-effective for delivering first-line IBS dietary advice. METHODOLOGY: This study, using a pre-post design, aimed to evaluate the effectiveness of a low-FODMAP diet restriction phase webinar at improving IBS symptoms. Participants with self-reported IBS symptoms were asked to report their IBS symptoms, stool frequency, stool consistency and IBS medication use, before and 8 weeks postwebinar via an online questionnaire. The presence and severity of participants' symptoms and bowel habits were captured using validated tools and a global symptom question. RESULTS: In total 228 participants responded to both pre- and postsurveys. A statistically significant improvement in all symptoms was observed 8 weeks postwebinar (p < 0.05). The proportion of participants rating their overall symptoms as moderate-to-severe reduced from 85.5% at baseline to 34.6% postwebinar (50.9% reduction [p < 0.001]). The proportion of participants reporting normal stool consistency and frequency significantly increased postwebinar (23.2%-39.9% [p < 0.001] and 76.3%-89% [p < 0.001], respectively). Satisfactory relief of symptoms increased from 16.7% to 53.1%, (p < 0.001) 8 weeks postwebinar. CONCLUSIONS: These results are comparable with literature on the efficacy of face-to-face delivery of low-FODMAP diet education. Dietitians should consider directing triaged patients with IBS, who have tried first-line dietary advice, to this webinar as an alternative or alongside current practice.

Evaluation of the effects of the FODMAP diet and probiotics on irritable bowel syndrome (IBS) symptoms, quality of life and depression in women with IBS.

BACKGROUND: The present study aimed to evaluate the effects of fermented oligosaccharide, disaccharide, monosaccharide and polyols (FODMAP) diet therapy and probiotics on irritable bowel syndrome (IBS) symptoms, quality of life and depression in women diagnosed with IBS. METHODS: For the study, 52 female IBS patients between the ages of 20 and 55 were enrolled. Individuals were monitored for 6 weeks in two groups. A low-FODMAP diet was given to the first group and a low-FODMAP diet plus a probiotic supplement was given to the second group (Lactobacillus rhamnosus). Three-day food intake records were kept at the start of the study and continued up to its conclusion, with a weekly check-in in between. At the start and end of the trial, participants completed the Hospital Anxiety and Depression Scale, IBS Quality of Life Scale (IBS-QOL) and IBS Symptom Severity Score (IBS-SSS). The Bristol Stool Scale was also used by the subjects to record their daily stool densities. RESULTS: At the end of the study, it was determined that the daily intake of FODMAP (lactose [g] + oligosaccharides [g] + mannitol [g] + sorbitol [g]) decreased significantly in both groups (p < 0.05). At the end of the study, it was determined that the IBS-SSS, anxiety and depression scores of the individuals in both groups decreased significantly and their IBS-QOL scores increased significantly (p < 0.05). However, the difference between these values between the groups was not statistically significant (p > 0.05). CONCLUSIONS: A low-FODMAP diet has been demonstrated to benefit people by lessening the severity of their IBS symptoms and enhancing their quality of life. No evidence was found, however, to indicate that the FODMAP diet would be more beneficial on these metrics if additional probiotics were used. It should be emphasised that the reaction of probiotic strains may vary depending on the IBS subtype.

Gastroenterologist Primer: Endometriosis for Gastroenterologists.

BACKGROUND AND AIM: A comprehensive understanding of endometriosis and its common gastrointestinal presentations are critical for gastroenterologists to ensure appropriate and timely screening and diagnosis. Endometriosis is a common inflammatory disease that frequently presents with gastrointestinal symptoms overlapping with irritable bowel syndrome (IBS) and other gastrointestinal disorders. Many endometriosis patients first present to a gastroenterologist or generalist, which may prolong the time to diagnosis and appropriate care. METHOD AND RESULTS: This review describes the current literature on endometriosis presentation, overlap with gastrointestinal conditions, and standard diagnostic and treatment options for gastroenterologists to consider. For appropriate and swift treatment, gastroenterologists must consider an endometriosis diagnosis in females of menstruating age presenting with pain, bloating, altered stools, and non-gastrointestinal symptoms and refer patients for further evaluation.

Irritable bowel syndrome in children with chronic gastrointestinal symptoms in primary care.

BACKGROUND: Irritable bowel syndrome (IBS) is the most common functional gastrointestinal disorder in children. However, in primary care, it is still unknown whether there are differences in the prognosis of children with IBS compared to other diagnostic subgroups. Therefore, our aim was to describe the course of symptoms and health-related quality of life (HRQoL) for children with chronic gastrointestinal symptoms who either do or do not fulfil the Rome criteria for IBS in primary care. Second, we compared the diagnosis of the general practitioner (GP) with the Rome criteria. METHODS: We conducted a prospective cohort study with 1-year follow-up, including children aged 4-18 years with chronic diarrhoea and/or chronic abdominal pain in primary care. During follow-up, the Rome III questionnaire, Child Health Questionnaire, and symptom questionnaires were completed. RESULTS: A total of 60/104 children (57.7%) fulfilled the Rome criteria for IBS at baseline. Compared to children without IBS, children with IBS were more commonly referred to secondary care, used more laxatives, and more often developed chronic diarrhoea and low physical HRQoL during 1 year. The diagnosis "IBS" from the GP matched the Rome criteria for only 10% of children, as most were diagnosed with "Constipation." CONCLUSIONS: There seems to be a difference in the treatment and prognosis of symptoms and HRQoL between children with and without IBS in primary care. This suggests that it is relevant to differentiate between these groups. The evaluation and use of feasible criteria to define IBS in different healthcare settings remains subject for further studies.

[Functional colopathy : still relevant ? Let's move to irritable bowel syndrome]. / La colopathie fonctionnelle : toujours d'actualité ? Place au syndrome de l'intestin irritable.

Irritable bowel syndrome is a functional disorder that is frequently encountered in general practice as well as in specialized consultations. Diagnostic criteria have been well established but there is currently no specific diagnostic test. The various gastroenterology societies have recently published recommendations for diagnostic and therapeutic management adapted to the pathophysiology and the availability of treatments in different countries. This article summarizes the main lines of these recommendations and in particular those of the Belgian consensus.

Le syndrome de l'intestin irritable est un trouble fonctionnel fréquemment rencontré en médecine générale comme en consultation spécialisée. Les critères diagnostiques ont bien été établis, mais il n'y a actuellement pas de test diagnostique spécifique. Les différentes sociétés de gastroentérologie ont récemment publié des recommandations pour une prise en charge diagnostique et thérapeutique adaptée à la physiopathologie, mais aussi à la disponibilité des traitements selon les pays. Cet article résume les grandes lignes de ces recommandations et, en particulier, celles du consensus belge.

[Long-term probiotic administration for irritable bowel syndrome: a legal need].

BACKGROUND: Irritable bowel syndrome (IBS) is one of the most common functional diseases of the gastrointestinal tract. Violations in the intestinal microbiocenosis play a significant role in the pathogenesis of this suffering. The probiotic strain Bifidobacterium longum 35624® has a strong evidence base for use in the management of patients with IBS. The duration of probiotic therapy and the need for repeated courses of probiotics require further study, which determined the need for this observational study. AIM: To compare the results of prolonged (12 weeks) and usual duration of courses of probiotic Bifidobacterium longum 35624® in patients with IBS. MATERIALS AND METHODS: 42 patients with a verified diagnosis of IBS of moderate and severe severity who met the inclusion criteria were recruited into the study. Patients were prescribed probiotic Bifidobacterium longum 35624® at a dose of 1 capsule (1×109 CFU), 1 time per day for 12 weeks. The course of the disease was assessed using the visual analogue scale, visceral sensitivity index (VSI), IBS symptom severity scale (IBS-SSS), quality of life indicators were assessed using the IBS-QoL questionnaire scales. Evaluation of indicators was carried out at the inclusion visit, on days 14, 28, 56, 84 of probiotic intake and on day 112 (28 days after the last dose of Bifidobacterium longum 35624®). RESULTS: The results obtained confirmed the ability of the probiotic Bifidobacterium longum 35624® to positively influence the course of IBS. The addition of the main therapy with a probiotic made it possible to achieve a significant decrease in the severity of abdominal pain, bloating, and stool disorders. The severity of IBS significantly decreased according to the results of IBS-SSS. Reliable positive dynamics of indicators on the scales IBS-QoL, VSI is shown. The most pronounced changes were observed by the end of the third month of taking Bifidobacterium longum 35624®. Thus, according to the IBS-SSS indicators, only by the end of the third month of observation, some patients achieved remission of the disease. All described changes were persistent and persisted one month after the end of the probiotic intake. CONCLUSION: The addition of a prolonged course of the probiotic Bifidobacterium longum 35624® to the basic therapy in patients with IBS allows a more pronounced and lasting effect to be achieved. A "post-probiotic" effect was shown - a decrease in VSI after the end of the intake of the probiotic strain. Given the chronic relapsing course of IBS, the use of repeated probiotic courses was proposed to prevent exacerbation of the disease.

Diet or medication in primary care patients with IBS: the DOMINO study - a randomised trial supported by the Belgian Health Care Knowledge Centre (KCE Trials Programme) and the Rome Foundation Research Institute.

BACKGROUND: In Europe, IBS is commonly treated with musculotropic spasmolytics (eg, otilonium bromide, OB). In tertiary care, a low fermentable oligosaccharides, disaccharides, monosaccharides and polyols (FODMAP) diet provides significant improvement. Yet, dietary treatment remains to be explored in primary care. We evaluated the effect of a smartphone FODMAP-lowering diet application versus OB on symptoms in primary care IBS. METHODS: IBS patients, recruited by primary care physicians, were randomised to 8 weeks of OB (40 mg three times a day) or diet and followed for 24 weeks. We compared IBS Symptom Severity Score and the proportion of responders (improvement ≥50 points) in all patients and the subgroup fulfilling Rome IV criteria (Rome+). We also evaluated treatment efficacy, quality of life, anxiety, depression, somatic symptom severity (Patient Health Questionnaire (PHQ15, PHQ9)) and treatment adherence and analysed predictors of response. RESULTS: 459 primary care IBS patients (41±15 years, 76% female, 70% Rome+) were randomised. The responder rate after 8 weeks was significantly higher with diet compared with OB (71% (155/218) vs 61% (133/217), p=0.03) and more pronounced in Rome+ (77% (118/153) vs 62% (98/158), p=0.004). Patients allocated to diet (199/212) were 94% adherent compared with 73% with OB (148/202) (p<0.001). The significantly higher response rate with diet was already observed after 4 weeks (62% (132/213) vs 51% (110/215), p=0.02) and a high symptom response persisted during follow-up. Predictors of response were female gender (OR=2.08, p=0.04) for diet and PHQ15 (OR=1.10, p=0.02) for OB. CONCLUSION: In primary care IBS patients, a FODMAP-lowering diet application was superior to a spasmolytic agent in improving IBS symptoms. A FODMAP-lowering diet should be considered the first-line treatment for IBS in primary care. TRIAL REGISTRATION NUMBER: NCT04270487.

Placebo Response Rates in Trials of Licensed Drugs for Irritable Bowel Syndrome With Constipation or Diarrhea: Meta-analysis.

BACKGROUND & AIMS: There are several licensed drugs for irritable bowel syndrome (IBS) that have proven efficacy in randomized controlled trials (RCTs), but placebo response rates are high. We conducted a systematic review and meta-analysis of licensed drugs to estimate magnitude of placebo response rate according to Food and Drug Administration (FDA)-recommended endpoints and to assess how this varies with stringency of the endpoint used to define response. METHODS: We searched MEDLINE, EMBASE CLASSIC and EMBASE, and the Cochrane central register of controlled trials (through January 2021) to identify RCTs comparing licensed drugs with placebo in adult IBS patients. Studies assessed efficacy according to at least one of composite response, abdominal pain response, or stool response. Data were extracted as intention-to-treat analyses, with dropouts assumed to be treatment failures and pooled using a random-effects model. RESULTS: There were 17 RCTs of licensed drugs versus placebo in IBS with constipation (4603 patients placebo) and 17 trials in IBS with diarrhea (3908 patients placebo). In IBS with constipation, according to FDA criteria, pooled composite, abdominal pain, and stool response rates with placebo over ≥6 of 12 weeks were 18.9%, 34.6%, and 30.1%, respectively. Evaluating response rates over ≥9 of 12 weeks led to placebo response rates of 4.3% for the composite endpoint, 24.5% for abdominal pain, and 7.7% for stool. In IBS with diarrhea, pooled placebo response rates according to FDA criteria were 16.2% for the composite endpoint, 40.2% for abdominal pain, and 16.2% for stool. Increasing the threshold used to define abdominal pain response from ≥30% improvement to ≥40% or ≥50% led to lower placebo response rates of 34.5% and 23.4%. CONCLUSIONS: Future RCTs should adhere to current FDA-recommended endpoints for IBS because these lead to lower placebo response rates. However, consideration should be given to further refining some of these to better differentiate between active drug and placebo.

Exposure based cognitive behavioral group therapy for IBS at a gastroenterological clinic - a clinical effectiveness study.

BACKGROUND: Patients with irritable bowel syndrome (IBS) may benefit from psychological treatment when diet changes and medications do not sufficiently reduce symptoms. Our research team has developed an exposure based cognitive behavioral therapy protocol (ECBT), which has been shown to be effective in several randomized controlled trials. AIM: To investigate the effectiveness of ECBT in clinical routine care at a gastroenterological clinic in Stockholm and to find predictors for treatment outcome. METHOD: A ten session ECBT based on our protocol was given face to face by licensed psychologists in groups of 4-6 patients. A total of 129 patients provided information regarding IBS symptoms, quality of life, gastrointestinal symptom-specific anxiety (GSA), and depression pre and post-treatment. We used linear regression analyses to identify patient characteristics that predicted treatment outcome. RESULTS: The primary outcome was symptom severity measured with The Gastrointestinal Symptom Rating Scale for IBS (GSRS-IBS). Average pre-and post-treatment GSRS-IBS scores were 49.24 (SD = 11.54) and 37.03 (SD = 10.03), corresponding to a 34.0% reduction in symptom severity (p < .001). Reductions were also found in GSA, 43.9% (p < .001) and depression, 38.6% (p < .001). IBS-related quality of life was on average increased by 68.2% (p < .001). The effect sizes were large and varied between (Cohen's d) 0.95 and 1.84. None of the patients' pre-treatment characteristics predicted outcome. CONCLUSION: We conclude that ECBT for IBS delivered face-to-face in a group-format is very effective, also in a routine care setting. We did not find any reliable predictors for treatment outcome. The trial was registered at Clinicaltrials.gov with ID: NCT04756414.

Chronic Abdominal Pain: Gastroenterologist Approach.

BACKGROUND: Abdominal pain is a common symptom of gastroenterology examination. Chronic abdominal pain is present for >3 months. SUMMARY: Gastroesophageal reflux disease (GERD) is one of the most common gastrointestinal diseases encountered by both gastroenterologists and general practitioners. GERD is usually a chronic disease presented with a set of symptoms including heartburn and/or regurgitation, and less commonly epigastric pain. Epigastric pain syndrome is characterized by the following symptoms: epigastric pain and/or burning. It does not necessarily occur after meal ingestion, may occur during fasting, and can be even improved by meal ingestion. Duodenal ulcers tend to cause abdominal pain that is localized in the epigastric region and commence several hours after eating, often at night. Hunger provokes pain in most of the cases and decreases after meal. Gastric ulcer pain occurs immediately after eating, and consuming food increases pain. Pain is localized in the epigastrium and can radiate to the back. Abdominal pain in irritable bowel syndrome is related to defecation. A typical symptom of chronic pancreatitis is pain that radiates to the back. In Crohn's disease, inflammation causes pain. Key Messages: Pain can occur at different locations with diverse intensity and propagation and is often associated with other symptoms. For any gastroenterologist, abdominal pain is a big challenge.

Probiotics therapy for adults with diarrhea-predominant irritable bowel syndrome: a systematic review and meta-analysis of 10 RCTs.

PURPOSE: Accumulating evidence showed that probiotics therapy might be effective in treating diarrhea-predominant irritable bowel syndrome (IBS-D). This study aimed to evaluate the effectiveness and safety of probiotics therapy for the treatment of IBS-D. METHODS: We performed a comprehensive literature search in eight electronic databases, and gray literature from inception to August 4, 2021. Randomized controlled trials (RCTs) of probiotics therapy for the treatment of IBS-D were included and the quality was assessed using the risk of bias tool recommended by the Cochrane Handbook version 5.1.0. RevMan 5.4 software was used to perform the meta-analysis on the outcomes of IBS-D symptoms, abdominal pain, quality of life, and abdominal distension. The Grading of Recommendations Assessment, Development and Evaluation (GRADE) approach was used to assess the certainty of evidence. RESULTS: Ten RCTs evaluating 943 patients were identified. Only one study had unclear risk of bias, while nine studies had a high risk of bias. The meta-analysis results showed that, compared to the placebo, probiotics therapy significantly decreased the score of IBS-D symptoms (SMD = - 0.55, 95% CI: [- 0.83, - 0.27], P < 0.05), abdominal pain (SMD = - 0.43, 95% CI: [- 0.57, - 0.29], P < 0.05), and abdominal distension (SMD = - 0.45, 95%CI: [- 0.81, - 0.09], P < 0.05). There was no statistical difference in the quality of life. However, all the certainty of evidence was very low. CONCLUSION: Very low certainty evidence showed that probiotics might be an effective treatment for improving the IBS-D symptoms, abdominal pain, and abdominal distension, in adult IBS-D patients. However, these conclusions should be supported by high-quality evidence.

An update on fecal microbiota transplantation for the treatment of gastrointestinal diseases.

Our understanding of the microbiome and its implications for human health and disease continues to develop. Fecal microbiota transplantation (FMT) is now an established treatment for recurrent Clostridioides difficile infection. There is also increasing evidence for the efficacy of FMT in inducing remission for mild-moderate ulcerative colitis. However, for other indications, data for FMT are limited, with randomized controlled trials rare, typically small and often conflicting. Studies are continuing to explore the role of FMT for many other conditions, including Crohn's disease, functional gut disorders, metabolic syndrome, modulating responses to chemotherapy, eradication of multidrug resistant organisms, and the gut-brain axis. In light of safety, logistical, and regulatory challenges, there is a move to standardized products including narrow spectrum consortia. However, the mechanisms underpinning FMT remain incompletely understood, including the role of non-bacterial components, which may limit success of novel microbial approaches.

Adjunctive treatment with probiotics partially alleviates symptoms and reduces inflammation in patients with irritable bowel syndrome.

PURPOSE: Irritable bowel syndrome (IBS) is a functional bowel disorder. This study aimed to assess the effect of a probiotic product (containing Lactobacillus casei Zhang, Lactobacillus plantarum P-8, and Bifdobacterium animalis subsp. lactis V9) as an adjunct to a routine regimen in IBS management. METHODS: Forty-five patients with IBS were randomized into the probiotic (n = 24) and control (n = 21) groups, receiving the routine regimen with or without probiotics for 28 days, respectively. Serum and fecal samples were collected and analyzed. RESULTS: The IBS-symptom severity score (P < 0.01), serum levels of IL-6 (P < 0.01) and TNF-α (P < 0.001) were significantly lower in the probiotic group than the control group at day 28. The probiotic adjunctive treatment resulted in significant decreases in some bacterial genera that worsen IBS, such as Bacteroides (P < 0.01), Escherichia (P < 0.05), and Citrobacter (P < 0.05), significant decreases were also observed in some beneficial genera in the control group, including Bifidobacterium (P < 0.05), Eubacterium (P < 0.05), Dorea (P < 0.01), and Butyricicoccus (P < 0.05). Furthermore, significant correlations were found between some monitored parameters and compositional changes in the fecal microbiota, suggesting that the clinical improvement of IBS was likely associated with gut microbiota modulation. The enterotype analysis revealed that the initial fecal microbiota composition could influence clinical outcomes. CONCLUSIONS: The adjunctive use of probiotics with a routine regimen showed additional clinical effectiveness compared to the routine regimen alone in managing IBS. A pretreatment gut microbiome analysis might help tailor a personalized probiotic regimen to optimize treatment effects.

Long-term symptom severity in people with irritable bowel syndrome following dietetic treatment in primary care: A service evaluation.

BACKGROUND: Evidence suggests that dietary interventions can improve symptoms in people with irritable bowel syndrome (IBS), although most data explore the short-term (immediate) impact. Data on long-term (>6 months) impact are limited, especially from primary care settings. The present study aimed to investigate the long-term effect of dietetic-led interventions for IBS delivered in primary care. METHODS: A service evaluation of a dietetic-led IBS clinic was completed, analysing data on symptom severity, stool frequency and consistency, and healthcare input. Data were collected before and immediately after dietary intervention as part of patients' routine clinical appointments. Long-term data were collected via a postal questionnaire at least 11 months later. RESULTS: In total, 211 patients responded to the long-term follow-up questionnaire at a median of 13 months (interquartile range 12-16 months) post follow-up appointment. Of these, 84% had been advised to follow a low FODMAP (i.e., fermentable oligosaccharides, disaccharides, monosaccharides and polyols carbohydrates) diet. All symptoms were reported significantly less frequently short term, and all except heartburn and acid regurgitation remained so over the long term. The four most commonly reported bowel symptoms reduced in frequency were abdominal pain (62%), bloating (50%), increased wind (48%) and urgency to open bowels (49%) (p < 0.001). The percentage of patients reporting satisfactory relief of gut symptoms was 10% at baseline and 55% at long-term follow-up (p < 0.001). Visits to a general practitioner were reduced (from 96% to 34%; p < 0.001), as were those to the gastroenterologist (from 37% to 12%; p = 0.002), during the year prior to long-term follow-up compared to the year prior to dietary intervention. CONCLUSIONS: Patients with IBS who received dietetic-led interventions in primary care reported long-term symptoms improvements that may result in reduced healthcare usage.

[Efficacy of trimebutine in the treatment of functional gastrointestinal disorders: an observational multicenter study].

AIM: Evaluation of the practice of using trimebutine (tablets, 300 mg, extended release), for the treatment of patients with functional gastrointestinal disorders (FGID) in primary health care. MATERIALS AND METHODS: A prospective observational multicenter non-interventional study was carried out, which included patients of both sexes aged 18 to 60 years with a verified diagnosis of functional gastrointestinal disorders (functional dyspepsia, irritable bowel syndrome, biliary tract dysfunction, sphincter of Oddi dysfunction, postcholecystectomy syndrome). Trimebutine was prescribed in accordance with the instructions for medical use: orally, 300 mg twice per day for 28 days. The severity of simptoms was evaluated by five-point rating scale. RESULTS: The study included 4433 patients, the per protocol sample consisted of 3831 people. The proportion of patients with a significant decrease in the severity of abdominal pain after treatment was 74.73% (95% confidence interval CI 73.3276.11). At the and of the study a statistically significant decrease in the severity of FGID` simptoms was observed: epigastric pain/burning (mean score at the 1st visit was 1.21 [95% CI 1.181.25], at the 2nd visit 0.22 [95% CI 0.20.23]; p0.001), abdominal pain (1st visit 2.01 [95% CI 1.982.04), 2nd visit 0.33 [95% CI 0.310.35]; p0.001), biliary pain (1st visit 1.22 [95% CI 1.181.26], 2nd visit 0.2 [95% CI 0.190.22]; p0.001), postprandial fullness and early satiation (1st visit 1.29 [95% CI 1.251.32], 2nd visit 0.21 [95% CI 0.190.22]; p0.001), severity of heartburn (1st visit 0.92 [95% CI 0.880.95], 2nd visit 0.18 [95% CI 0.170.20]; p0.001), belching (1st visit 1.13 [95% CI 1.091.16], 2nd visit 0.22 [95% CI 0.210.24]; p0.001), as well as abdominal distention (1st visit 1.99 (95% CI 1, 96, 2.03), 2nd visit 0.43 [95% CI 0.410.45]; p0.001). CONCLUSION: The present prospective observational multicenter non-interventional study has demonstrated that trimebutine is an effective approach to treating FGID.