Irritable Bowel Syndrome

80

Review clinical trials related to Irritable Bowel Syndrome. Use filters to narrow results by trial status, phase, treatment, biological sex and sponsor.

Condition / disease
Location
Status: Not yet recruiting

The Mechanism Underlying the Analgesic Effect of the Music of IBS Pain

The proposed pilot study aims to assess the underlying mechanisms of the MBI on IBS pain and the feasibility of using novel technology in the outcome measurements. The specific aims of this pilot mechanistic clinical trial are to: 1. . identify the mechanisms underlying the impact of MBI on IBS-related pain, stress responses, quantitative pain sensitivity, and gut microbiome profiles. 2. . evaluate the technological feasibility of using a wearable abdominal sensor belt and smartwatch system in measuring MBI impacts on pain in home settings. Researchers will conduct a one-arm pre- and post-music intervention among patients with Irritable Bowel Syndrome, collect the IBS pain mechanistic biobehavioral markers, and analyze the underlying pathways of the music analgesic effect. Participants will be asked to: 1. . engage in a 4-week intervention of 20 minutes, both during the day and at night, for at least five days per week. 2. . have two one-hour lab visits

Participants needed: 30
Trial details
Age: 18-50Biological sex: AllType: InterventionalSponsor: Yale UniversityUpdated: Jul 2, 2026Locations: 1
Eligibility criteria

aged between 18 and 50 years old, [+5]

having a severe psychiatric disorder requiring inpatient treatment in the past s... [+3]

Status: Recruiting

Brachyspira and Intestinal Allergy-like Immune Reactions in Patients With Irritable Bowel Syndrome (IBS)

The aim of this study is to define local immune responses in the GI tract to food antigens in IBS patients, with and without Brachyspira infection, using advanced imaging. We hypothesize that Brachyspira infection can cause IBS symptoms by inducing loss of oral tolerance to dietary antigens through development of food-specific intestinal immune reactions and subsequent development of visceral hypersensitivity. During this study, the investigators will perform confocal laser endomiscroscopy (CLE) and/or colonoscopic antigen provocation test (COLAP) to test to which food items the participants react to. Furthermore, the investigators will perform rectal barostat examination and a sigmoidoscopy without laxatives. The investigators will collect biological samples and the participants will complete several questionnaires.

Participants needed: 200
Trial details
Age: 18-70Biological sex: AllType: InterventionalSponsor: Magnus SimrénUpdated: Jun 29, 2026Locations: 1
Eligibility criteria

Patients with IBS diagnosis according to their treating physician (ROME IV). [+3]

Patients with relevant concurrent organic GI disease (inflammatory bowel disease... [+6]

Status: Not yet recruiting

A Pilot Study Using Gut-Directed Hypnotherapy for Hospitalized Patients

The purpose of the study is to compare the effectiveness of recorded gut-directed hypnosis to an educational recording in people with chronic problems in their gastrointestinal (GI) system. Patients who are hospitalized at Stanford Hospital for worsening pain and/or nausea will be considered for enrollment.

Participants needed: 26
Trial details
Age: 18+Biological sex: AllType: InterventionalSponsor: Stanford UniversityUpdated: Jun 30, 2026Locations: 1
Eligibility criteria

Adults admitted to the GI inpatient service with expected length of stay >24 hou... [+2]

Currently using hypnosis [+6]

Status: Recruiting

A Study to Investigate Abdominal Symptoms With Camlipixant Compared With Placebo in Adults With Irritable Bowel Syndrome - Diarrhea (IBS-D) and Irritable Bowel Syndrome - Mixed (IBS-M)

This study is designed to evaluate the efficacy and safety of camlipixant in adults with IBS-D and IBS-M. The study has two parts. After the first part, some participants will be randomly chosen again to either get a higher dose or stop the drug.

Participants needed: 420
Trial details
Phase: Phase 2Age: 18-80Biological sex: AllType: InterventionalSponsor: GlaxoSmithKlineUpdated: Jun 25, 2026Locations: 110
Eligibility criteria

Male or female aged 18 to 80 years inclusive, at the time of signing the Informe... [+5]

Diagnosis of Irritable bowel syndrome - constipation (IBS-C) or Irritable bowel... [+18]

Status: Recruiting

Defining Objective Markers of Compliance for Dietary Therapies in IBS

This research will investigate if a specific marker in your stool or urine can be used to track changes in your carbohydrate intake including fructo-oligosaccharide and mannitol intake

Participants needed: 94
Trial details
Age: 18-65Biological sex: AllType: InterventionalSponsor: University of MichiganUpdated: Jun 22, 2026Locations: 1
Eligibility criteria

Patients with IBS ( including diarrhea, mixed or constipation type) and without... [+2]

Subjects adhering to a dietary treatment such as the low-fat diet, low FODMAP di... [+9]

Status: Recruiting

Well-being in IBS: Strengths and Happiness (WISH) 2.0

The purpose of this study is to examine the feasibility, acceptability, preliminary effects, and candidate gut-brain mechanisms of an optimized positive psychology (PP) intervention for patients with irritable bowel syndrome (IBS), entitled "WISH," compared to an educational control intervention.

Participants needed: 50
Trial details
Age: 18+Biological sex: AllType: InterventionalSponsor: Massachusetts General HospitalUpdated: Jun 22, 2026Locations: 1
Eligibility criteria

IBS Diagnosis: Adult patients with an IBS diagnosis meeting standardized Rome IV... [+1]

Presence of inflammatory bowel disease or other structural/biochemical primary g... [+4]

Status: Recruiting

The Stool Microbiome of Treated and Untreated IBS (Irritable Bowel Syndrome) Patients

Irritable bowel syndrome (IBS) is considered the most common gastrointestinal disorder in humans, with an estimated global prevalence of 11%-20% of all humans. Alterations in the gut microbiome are at the center of IBS, and microbiome-induced volatile metabolites in response to dietary exposures is believed to drive a downstream impact on susceptible hosts, thereby driving the disease. However, the characteristics and functions of these metabolites remain unknown to date. The two main mechanisms invoking IBS development and flares include 1) an increase in luminal water content due to malabsorption of small molecules and 2) incrementation of colon gas production generated by the fermentation of small molecules by gut bacteria.Yet to date, a person-specific elucidation of the specific small molecules and bacteria driving IBS, and their downstream effects on the human gut epithelium remain unknown. Over the past years, it became evident that dietary regimes, and their interactions with the intestinal microbiome, are at the center of IBS symptom generation and alleviation. The most widely used dietary intervention is a highly restrictive diet, the low-Fermentable Oligo-saccharides Di-saccharides Mono-saccharides And Polyols (FODMAP) diet, based on avoidance of multiple food items that contain available fermentable molecules. The low-FODMAP diet remains an effective line of treatment for IBS patients, yet due to its complexity and unhealthy nature, it remains a last line of treatment and fails to impact the majority of IBS patients.

Participants needed: 100
Trial details
Age: 18-70Biological sex: AllType: InterventionalSponsor: Weizmann Institute of ScienceUpdated: Jun 11, 2026Locations: 1
Eligibility criteria

Male and Female [+1]

Consumption of antibiotics 2 months prior to the first day of the experiment. [+9]

Status: Recruiting

Psyllium in Pediatric IBS

The goal of this clinical trial is to learn if a fiber (psyllium) can change the way bacteria use fructans (a type of sugar) and whether psyllium can help decrease childhood irritable bowel syndrome (IBS) symptoms when eating fructans. The main questions it aims to answer are: Aim 1: The effect of psyllium at two doses given with a fructan meal on microbial fructan fermentation (intracolonic pH; H2 gas production; gut microbiome composition; fecal short-chain fatty acids, lactate, glycomics). Aim 2: Determine the impact of psyllium given with a fructan meal on fructan-induced GI symptoms. Participants will first be asked to eat a specific diet over two three-day periods to determine if fructans worsen their IBS symptoms. Those with worsening symptoms with fructans will be asked to participate in the second part of the study. This includes two weeks of baseline (no change in diet) and two weeks of eating a specific diet with fructans with either psyllium or glucose. Participants will be asked to complete pain and stool diaries, submit stool specimens, swallow a pill to capture gut acid levels, and give breath samples.

Participants needed: 110
Trial details
Phase: Phase 2Age: 12-17Biological sex: AllType: InterventionalSponsor: Dr Bruno Chumpitazi, M.D.Updated: May 26, 2026Locations: 1
Eligibility criteria

Children between the ages of 12-17 years meeting pediatric Rome IV criteria for...

Children who have had previous bowel surgery, have documented GI disorders (e.g.... [+4]

Status: Not yet recruiting

A Well-Being Intervention for People With IBS

The purpose of this randomized behavioral clinical trial is to examine whether a well-being intervention can improve both psychological well-being and physical outcomes in adults with Irritable Bowel Syndrome (IBS). The study aims to assess whether this intervention decreases anger, anxiety, and depression; increases self-esteem, empathy, and hope; and improves quality of life indicators such as IBS symptom severity, sleep quality, fatigue, and diet. Participants can expect to be on study for up to 9 months.

Participants needed: 150
Trial details
Age: 18+Biological sex: AllType: InterventionalSponsor: University of Wisconsin, MadisonUpdated: May 22, 2026Locations: 1
Eligibility criteria

Men and women currently diagnosed with Irritable Bowel Syndrome (IBS) by a healt... [+4]

Individuals with cognitive impairments or reading difficulties that would interf... [+3]

Status: Recruiting

A Study of Brenipatide (LY3537031) in Participants With Irritable Bowel Syndrome-Diarrhea (IBS-D)

The purpose of this study is to evaluate how well brenipatide (LY3537031) is tolerated, what side effects may occur, and the safety and efficacy in participants with Irritable Bowel Syndrome-Diarrhea (IBS-D). The study drug will be administered subcutaneously (SC) (under the skin) when compared with placebo. The study will last approximately 35 weeks.

Participants needed: 531
Trial details
Phase: Phase 2Age: 18-75Biological sex: AllType: InterventionalSponsor: Eli Lilly and CompanyUpdated: May 13, 2026Locations: 88
Eligibility criteria

Meet Rome IV criteria for IBS-D, which includes having greater than 25% of bowel... [+3]

Have a diagnosis of IBS with a subtype of constipation, mixed IBS, or unclassifi... [+2]

Status: Recruiting

A Study of Brenipatide (LY3537031) in Participants With Irritable Bowel Syndrome-Constipation (IBS-C)

The purpose of this study is to evaluate how well brenipatide (LY3537031) is tolerated what side effects may occur, and the safety and efficacy in participants with Irritable Bowel Syndrome-Constipation (IBS-C). The study drug will be administered subcutaneously (SC) (under the skin) when compared with placebo. The study will last approximately 35 weeks.

Participants needed: 342
Trial details
Phase: Phase 2Age: 18-75Biological sex: AllType: InterventionalSponsor: Eli Lilly and CompanyUpdated: May 13, 2026Locations: 1
Eligibility criteria

Meets Rome IV criteria for irritable bowel syndrome-constipation (IBS-C) includi... [+1]

Have a diagnosis of irritable bowel syndrome (IBS) with a subtype of diarrhea, m... [+2]

Status: Recruiting

Evaluation of Efficacy of Skål Pro Powder on Symptoms of Irritable Bowel Syndrome

The objective of this randomized, double-blind, placebo-controlled study is to evaluate the effectiveness of Skal Pro in alleviating symptoms, enhancing stool consistency, improving quality of life, and addressing psychological distress in individuals diagnosed with irritable bowel syndrome (IBS), as compared to those who receive no intervention.

Participants needed: 60
Trial details
Phase: Phase 4Age: 18+Biological sex: AllType: InterventionalSponsor: EP Plus Group Sdn BhdUpdated: May 12, 2026Locations: 1
Eligibility criteria

IBS diagnosed using the Rome IV criteria [+2]

Presence of red flag symptoms (weight loss, anemia, night symptoms, abdominal ma... [+9]

Status: Recruiting

Repeated Transcranial Magnetic Stimulation for the Treatment of Diarrhea-Predominant Irritable Bowel Syndrome: A Randomized Clinical Trial

Objectives: This study aims to evaluate the clinical efficacy and safety of repetitive transcranial magnetic stimulation (rTMS) in patients with diarrhea-predominant irritable bowel syndrome (IBS-D), and to explore the potential underlying mechanisms by which rTMS alleviates clinical symptoms in IBS-D patients. Design: This is a clinical trial that uses clinical symptom scales to assess the therapeutic effect of rTMS on IBS-D patients. Meanwhile, gut microbiota and metabolite profiling, as well as the methane-hydrogen breath test, will be applied to investigate the mechanism of action from the perspectives of gut microecology, intestinal motility, and metabolism, so as to provide scientific evidence for the clinical application of rTMS in the treatment of IBS-D.

Participants needed: 46
Trial details
Age: 18-70Biological sex: AllType: InterventionalSponsor: The First Affiliated Hospital of Soochow UniversityUpdated: May 12, 2026Locations: 1
Eligibility criteria

Not listed

Status: Recruiting

Fecal Microbiota Transplantation for IBS

The purpose of this study is to learn the efficacy and safety of fecal microbiota transplantation (FMT) using stool from a donor with low proteolytic activity and containing the bacteria Alistipes putredinis in patients with irritable bowel syndrome (IBS) and high proteolytic activity. Proteolytic activity is the breakdown of proteins into smaller polypeptides or amino acids.

Participants needed: 43
Trial details
Phase: Phase 2Age: 18-70Biological sex: FemaleType: InterventionalSponsor: Madhusudan (Madhu) Grover, MBBSUpdated: May 8, 2026Locations: 1
Eligibility criteria

IBS defined by Rome IV criteria [+3]

Immune deficiency or treatment with immunosuppressive medications [+12]

Status: Not yet recruiting

Effect of Neurodynamic Mobilization of Vagus Nerve on Irritable Bowel Syndrome in Women

goal of this interventional study to investigate the effect of neurodynamic mobilization of vagus nerve on irritable bowel syndrome in women. The main question it aims to answer is: is there an effect of neurodynamic mobilization of the vagus nerve on irritable bowel syndrome? The intervention will include neurodynamic mobilization of vagus nerve sessions ,Participants will receive the treatment for 6 week. Assessment will be done before and after treatment.

Participants needed: 32
Trial details
Age: 20-45Biological sex: FemaleType: InterventionalSponsor: Cairo UniversityUpdated: May 7, 2026Locations: 1
Eligibility criteria

32 Females with mild to moderate IBS ,were recruited for this study by referral... [+4]

Organic gastrointestinal disorders. [+10]

Status: Recruiting

Feasibility Assessment of Cardiovascular Endurance Training for the Symptomatic Improvement of Irritable Bowel Syndrome Patients With a Sedentary and Non-active Lifestyle.

This exploratory study's primary objective is the changes of irritable bowel syndrome (IBS) symptom severity by cardiovascular endurance training (CET) in relation to the baseline sedentary or non-active lifestyle. Secondary endpoints focus on the mechanisms associated with these changes. These mechanisms relate to dietary adaptations, changes in anxiety, depressive comorbidity, somatisation, alterations in the gut microbiome or metabolome, body composition and measures of cardiovascular fitness. Virtually all IBS guidelines mention lifestyle modifications as a management option. Research on the role of physical activity remains underassessed as compared to the other interventions. Therefore, an exploratory proof-of-concept study will investigate the influence of regular physical exercise on symptoms in a small group of IBS patients. This study will gather data on putative underlying mechanisms related to dietary factors, faecal microbiome and metabolome, mental well-being, body composition and cardiovascular fitness.

Participants needed: 30
Trial details
Age: 18-60Biological sex: AllType: InterventionalSponsor: Universitair Ziekenhuis BrusselUpdated: May 6, 2026Locations: 1
Eligibility criteria

Patients aged 18 - 60 years; [+4]

Cardiorespiratory disorder hampering participation in a program of physical exer... [+15]

Status: Not yet recruiting

Psychoemotional Status and Functional Gastrointestinal Disorders

This prospective cohort study will evaluate the influence of psychoemotional status on the clinical course and quality of life of adult patients with functional dyspepsia and/or irritable bowel syndrome diagnosed according to Rome IV criteria. The study aims to assess the contribution of affective and somatoform disorders to quality of life and symptom burden in these patients. In participants with functional dyspepsia, the association of Helicobacter pylori status with psychoemotional status and quality of life will also be evaluated. Patients will complete validated questionnaires assessing quality of life, depression, anxiety, and somatization at baseline and again during follow-up after treatment. Clinical symptoms, pain severity, stool characteristics, and H. pylori status will also be assessed as applicable.

Participants needed: 150
Trial details
Age: 18+Biological sex: AllType: ObservationalSponsor: Center of New Medical TechnologiesUpdated: Apr 20, 2026Locations: 1
Eligibility criteria

Age 18 years and older [+2]

Age younger than 18 years [+5]

Status: Not yet recruiting

Effect of Autogenic Relaxation Training on Irritable Bowel Syndrome In Adult Females

This study will be conducted to determine the effect of autogenic relaxation training on irritable bowel syndrome in adult females.

Participants needed: 44
Trial details
Age: 20-35Biological sex: FemaleType: InterventionalSponsor: Cairo UniversityUpdated: Apr 16, 2026Locations: 1
Eligibility criteria

Patients diagnosed with irritable bowel syndrome (IBS) based on Rome IV diagnost...

Organic gastrointestinal disorder, thyroid dysfunction, respiratory, renal, hepa... [+2]

Status: Recruiting

Home-based Transcutaneous Auricular Vagus Nerve Stimulation (taVNS) for IBS Pain

The goal of this clinical trial is to learn the feasibility and safety of using home-based taVNS in young adults with IBS to manage their IBS-related pain and symptoms. It will also learn about participants' experience in using the home-based taVNS intervention. The main questions it aims to answer are: * Is it feasible to use a home-based taVNS intervention for pain and symptom management among YAs with IBS? * Is it safe and reported satisfactory to use a home-based taVNS intervention for pain and symptom management among YAs with IBS? Researchers will compare Active to Sham taVNS (a look-alike intervention that contains minimal stimulation) to see if Active taVNS works on managing IBS-related pain and symptoms. Participants will: * Take Active or Sham taVNS intervention for a 6-week treatment (twice daily, 30 minutes per session) * Visit the research lab at the initial setup and the end of the 6-week treatment for checkups and tests * Keep a diary of their symptoms and the number of times they use the taVNS.

Participants needed: 80
Trial details
Age: 18-29Biological sex: AllType: InterventionalSponsor: Yale UniversityUpdated: Apr 13, 2026Locations: 1
Eligibility criteria

18 - 29 years of age; [+5]

Other chronic pain condition; [+7]

Status: Not yet recruiting

Rifaximin Treatment in Bloating Predominant Functional Bowel Disorders

This randomized, double-blind, placebo-controlled trial will evaluate whether a 14-day course of rifaximin improves bloating in adult patients with Rome IV functional bowel disorders in whom bloating is the predominant symptom. Eligible participants with irritable bowel syndrome, functional constipation, or functional abdominal bloating/distension and bothersome bloating despite adequate bowel movement management will be assigned in a 1:1 ratio to rifaximin 550 mg three times daily or matching placebo for 2 weeks. The primary endpoint is the proportion of participants with bloating response, defined as at least a 1-point reduction from baseline in a 7-point Likert bloating score at the end of treatment.

Participants needed: 78
Trial details
Phase: Phase 3Age: 18-80Biological sex: AllType: InterventionalSponsor: Mahidol UniversityUpdated: Apr 13, 2026Locations: 1
Eligibility criteria

Adults aged 18 to 80 years. [+3]

History of major gastrointestinal surgery, except appendectomy or laparoscopic c... [+6]

Status: Recruiting

Exercise Interventions and Dietary Advice in Fibromyalgia and IBS

Fibromyalgia (FM) is a chronic disorder marked by widespread musculoskeletal pain, fatigue, sleep disturbances, and cognitive difficulties. Patients often experience hyperalgesia, allodynia, and muscle weakness. Central sensitization plays a key role, making the nervous system more responsive to pain. Though muscles are mainly affected, joint pain, stiffness, and reduced mobility are also common. Chronic pain and poor posture can worsen musculoskeletal health. FM is not mainly inflammatory, but pain and stress may affect bone health. Sleep disorders, like non-restorative sleep and apnea, are frequent and worsen fatigue. Neurotransmitter imbalances (e.g., serotonin, dopamine) affect pain and muscle function. The American College of Rheumatology defines FM by widespread bilateral pain lasting at least three months. FM mainly affects women, with a prevalence of 0.2-6.6%, often starting between the ages of 30 and 35. Besides physical symptoms, many patients suffer from anxiety, depression, and mood disorders, affecting their quality of life. Gastrointestinal issues, especially irritable bowel syndrome (IBS), are also frequent in FM patients. Both conditions share mechanisms such as pain hypersensitivity, altered autonomic regulation, gut-brain axis disruption, and immune dysfunction. Low-grade inflammation and intestinal permeability may contribute to chronic symptoms. FM treatment includes anticonvulsants, antidepressants, and painkillers. IBS is managed with diet changes and medications like antispasmodics. Due to limited drug effectiveness, multidisciplinary approaches are gaining attention. Physical exercise is a proven non-drug strategy that improves pain, fatigue, and mental health in FM and IBS. Still, adherence is low due to fear of pain, fatigue, and low motivation. Exercise, especially aerobic activity, benefits IBS patients by improving gut symptoms and reducing inflammation. It may also strengthen the gut barrier in both conditions. While optimal programs need more study, exercise is a promising therapy. Major health bodies recommend aerobic, resistance, and flexibility training for FM and aerobic exercise for IBS.

Participants needed: 30
Trial details
Age: 30-65Biological sex: AllType: InterventionalSponsor: Azienda Ospedaliera Specializzata in Gastroenterologia Saverio de BellisUpdated: Mar 27, 2026Locations: 1
Eligibility criteria

Confirmed diagnosis of Irritable Bowel Syndrome (IBS) concomitant with Fibromyal... [+3]

Individuals with severe cardiac, hepatic, neurological, psychiatric disorders, o... [+1]

Status: Recruiting

Efficacy of the DOMINO Diet App in IBS

The aim of this study is to evaluate whether the DOMINO diet application is an effective tool in the treatment of Irritable bowel syndrome in tertiary care. Furthermore, this study aims to determine the response rate of the strict low FODMAP diet in non-responders to the DOMINO diet.

Participants needed: 110
Trial details
Age: 18-70Biological sex: AllType: InterventionalSponsor: Universitaire Ziekenhuizen KU LeuvenUpdated: Mar 19, 2026Locations: 1
Eligibility criteria

Voluntary written informed consent of the participant or their legally authorize... [+3]

Participant has a history of any major psychiatric disorders (including those wi... [+7]

Status: Not yet recruiting

Low-FODMAP Diet and Intestinal Permeability in Patients With Irritable Bowel Syndrome

This study aimed to evaluate the effects of a Low-FODMAP diet on intestinal permeability, symptom severity, and quality of life in patients with Irritable Bowel Syndrome (IBS). Twenty-four patients diagnosed with IBS according to the Rome IV criteria were randomized to either a Low-FODMAP diet or a traditional diet for four weeks. Stool zonulin family peptides (ZFP), IBS Symptom Severity Score (IBS-SSS), and IBS Quality of Life (IBS-QOL) questionnaires were recorded at baseline and after the dietary intervention. In the Low-FODMAP group, FODMAP-containing foods were gradually reintroduced under dietitian supervision, and assessments were repeated at week 16 to evaluate long-term effects.

Participants needed: 24
Trial details
Age: 18-65Biological sex: AllType: InterventionalSponsor: Istanbul Medipol University HospitalUpdated: Mar 12, 2026
Eligibility criteria

IBS-specific treatment within the last 1 month

Status: Recruiting

Efficacy and Safety Evaluation of Fecal Microbiota Transplantation in Irritable Bowel Syndrome

Participants will be given FMT through oral capsules or nasojejunal tube once a month. After three-time treatment, participants were followed up for three months. Participants complete specific scales to assess improvement in symptoms, emotion and quality of life. Besides, they report adverse effects and collect fecal samples at each visit.

Participants needed: 102
Trial details
Age: 18-70Biological sex: AllType: InterventionalSponsor: Shanghai Zhongshan HospitalUpdated: Feb 25, 2026Locations: 1
Eligibility criteria

Patients who fulfilled the Rome IV criteria for the diagnosis of IBS, aged 18-70... [+2]

Pregnant, planning pregnancy or lactating; [+6]

Status: Recruiting

Effectiveness of a Dietary Supplement in Irritable Bowel Syndrome

Irritable bowel syndrome (IBS) affects around 5% of the general population and remains a daily problem in clinicians' practices, with inconsistent efficacy of treatments despite patients' high expectations. Intestinal hyperpermeability and visceral hypersensitivity are the two major components of IBS, and both can disrupt gastrointestinal function and ultimately impair patients' quality of life. Glutamine is a non-essential amino acid that regulates numerous metabolic pathways and plays a key role in the intestine as it is the preferred substrate for enterocytes and immune cells. A decrease in intestinal glutamine synthetase has been found in IBS, suggesting its involvement in the intestinal permeability and visceral hypersensitivity observed in patients. Ex vivo, glutamine is capable of restoring the expression of tight junction proteins in IBS-D patients. Furthermore, glutamine supplementation is capable of reducing abdominal pain and restoring intestinal permeability disorders in a sub-group of patients with intestinal permeability disorders (post-infectious IBS-D). The marine peptides Gabolysat® produced by the Dielen Laboratory have demonstrated their efficacy on intestinal permeability and inflammation in a preclinical model of IBS (Langlois et al. 2023), similar to glutamine supplementation in these animals. The Dielen® Protect product formulated on the basis of the results of this study combines glutamine and Gabolysat® to provide a comfort solution for IBS patients. Our working hypothesis is that patients suffering from moderate or severe IBS could benefit from oral supplementation with DIELEN Protect to improve the symptoms associated with IBS. 100 patients with IBS (according to Rome IV criteria) will be included in our study. All patients will test the treatment for 8 weeks (dielen protect or placebo). The efficacy will be compared between the 2 groups before and after the treatments using validated questionnaires. Therefore, all participants will fill questionnaire before and after 8 weeks of treatments : IBS severity (IBS-SSS), quality of life (GIQLI), Anxiety and depression (HAD), GI symptom related anxiety (VSI), stool frequency and consistancy (BSF scale). Microbiota, metabolomic and short chain fatty acid will be analysed before and after the intervention.

Participants needed: 100
Trial details
Phase: Phase 2Age: 18-75Biological sex: AllType: InterventionalSponsor: University Hospital, RouenUpdated: Feb 23, 2026Locations: 1
Eligibility criteria

Irritable bowel syndrome according to Rome IV criteria [+6]

Taking probiotics, food supplements containing glutamine, anti-inflammatory drug... [+6]