NCT07039747 Effectiveness of a Dietary Supplement in Irritable Bowel Syndrome
| NCT ID | NCT07039747 |
| Status | Recruiting |
| Phase | Phase 2 |
| Sponsor | University Hospital, Rouen |
| Condition | Irritable Bowel Syndrome |
| Study Type | INTERVENTIONAL |
| Enrollment | 100 participants |
| Start Date | 2025-04-22 |
| Primary Completion | 2027-02 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
In Phase 2, researchers evaluate early signs of effectiveness. You may be randomized to receive the active treatment or a comparator. Monitoring continues closely.
This trial targets 100 participants in total. It began in 2025-04-22 with a primary completion date of 2027-02.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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.
Eligibility Criteria
Inclusion Criteria: * Irritable bowel syndrome according to Rome IV criteria * Aged between 18 and 75 years * IBS-SSS \> 175 at inclusion * For women of childbearing age, use of effective contraception (progestins or oestroprogestins or intrauterine device or tubal ligation) for 1 month unless postmenopausal (amenorrhoea of at least 12 months or biologically confirmed diagnosis) or woman who has had a hysterectomy or salpingectomy. * Irritable bowel syndrome treatments that have been stable for more than one month * Membership of a social security scheme * Patient has read and understood the information letter and signed the consent form Exclusion Criteria: * Taking probiotics, food supplements containing glutamine, anti-inflammatory drugs or antibiotics in the month preceding the study. * Allergy to fish and glutamine * Known renal insufficiency (Glomerular Filtration Rate (GFR)\<30mL/min/1.73m2), known hepatic insufficiency (Prothrombin Time (PT)\<70%) or known cardiac disease. * History of organic digestive disease (coeliac disease, inflammatory bowel disease, abdominal surgery other than appendectomy or cholecystectomy) * Pregnant women, women in labour or breastfeeding mothers * Person deprived of liberty by an administrative or judicial decision or person placed under court protection / sub-guardianship or guardianship * Patient taking part in another trial / having taken part in another trial within a 4-week period
Contact & Investigator
Chloé MELCHIOR, PUPH
PRINCIPAL INVESTIGATOR
University Hospital, Rouen
Frequently Asked Questions
Who can join the NCT07039747 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 75 Years, studying Irritable Bowel Syndrome. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT07039747 trial and what does that mean for participants?
Phase 2 trials evaluate whether the treatment shows signs of effectiveness while continuing to monitor safety. More participants are enrolled than in Phase 1 to help refine the treatment protocol.
Is NCT07039747 currently recruiting?
Yes, NCT07039747 is actively recruiting participants. Contact the research team at Chloe.Melchior@chu-rouen.fr for enrollment information.
Where is the NCT07039747 trial being conducted?
This trial is being conducted at Rouen, France.
Who is sponsoring the NCT07039747 clinical trial?
NCT07039747 is sponsored by University Hospital, Rouen. The principal investigator is Chloé MELCHIOR, PUPH at University Hospital, Rouen. The trial plans to enroll 100 participants.