Glutamine supplement (DIELEN® Protect) to reduce IBS symptoms

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This randomized, placebo-controlled Phase 2 trial at CHU de Rouen will compare the glutamine-containing supplement DIELEN® Protect with a matching placebo in adults with Rome IV IBS and moderate-to-severe symptoms (IBS-SSS >175). Participants must be 18–75 years old, have stable IBS treatments for more than a month, and agree to contraception rules if applicable, while recent use of probiotics, glutamine supplements, antibiotics, or certain drugs excludes them. The trial builds on laboratory and small clinical data suggesting glutamine can restore intestinal tight junction proteins, reduce hyperpermeability, and lessen abdominal pain in IBS‑D, using symptom scores and permeability-related measures as key endpoints. Patients will receive active or placebo supplement with scheduled follow-up visits at the Rouen site to monitor efficacy and safety.

Why it matters

Who can join: the full rules

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

Where it's running

• CHU de Rouen
  Rouen, France, France Recruiting

Study contacts

• Principal investigator: Chloé MELCHIOR, PUPH — University Hospital, Rouen
• Study coordinator: Chloé MELCHIOR, PUPH
• Email: Chloe.Melchior@chu-rouen.fr
• Phone: 00332 32 88 67 07

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.