Glutamine supplement (DIELEN® Protect) to reduce IBS symptoms

Effectiveness of a Dietary Supplement in Irritable Bowel Syndrome

This will test whether a glutamine-containing supplement (DIELEN® Protect) can reduce symptoms in adults aged 18–75 with Rome IV‑defined IBS and an IBS‑SSS score above 175.

Quick facts

• Phase: Phase 2
• Study type: Interventional
• Enrollment: 100 (estimated)
• Ages: 18 Years to 75 Years
• Sex: All
• Sponsor: University Hospital, Rouen (Academic / other)
• Locations: 1 site (Rouen, France)
• Trial ID: NCT07039747 on ClinicalTrials.gov

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.

Who should consider this trial

Good fit: Adults 18–75 with Rome IV‑defined IBS and an IBS‑SSS score greater than 175 who have been on stable IBS treatments and can attend visits at CHU de Rouen are ideal candidates.

Not a fit: People with recent probiotic or glutamine use, allergies to fish or glutamine, significant kidney, liver, or cardiac insufficiency, or who cannot attend the Rouen study site are unlikely to be eligible or benefit.

Why it matters

Potential benefit: If successful, the supplement could reduce abdominal pain and gut permeability problems, improving daily symptoms and quality of life for people with IBS.

How similar studies have performed: Preclinical work and small clinical reports have suggested glutamine can improve intestinal permeability and symptoms in IBS, but randomized, larger-scale confirmation is limited.

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

Where this trial is running

Rouen, France

• CHU de Rouen — Rouen, France, France (Recruiting)

Study contacts

• Principal investigator: Chloé MELCHIOR, PUPH — University Hospital, Rouen
• Study coordinator: Chloé MELCHIOR, PUPH

Conditions Irritable Bowel Syndrome; glutamine