Could a simple supplement soothe IBS?

NCT ID NCT07039747

Symptom relief Sponsor: University Hospital, Rouen Source: ClinicalTrials.gov ↗

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study tests whether a dietary supplement called DIELEN Protect, which contains glutamine and marine peptides, can ease symptoms of irritable bowel syndrome (IBS). One hundred adults with moderate to severe IBS will take either the supplement or a placebo for 8 weeks. Researchers will measure changes in symptom severity, quality of life, and gut bacteria to see if the supplement helps.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance: DIELEN® Protect (glutamine and Gabolysat® marine peptides)
What this could lead to: If it works, this could offer a natural supplement option to reduce IBS severity and improve quality of life.
What could go wrong: This is an early phase 2 trial with only 100 participants, so results may not apply to everyone. The supplement may not outperform placebo.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

About 100 people

The number the study aims to enrol. It can still change while the study runs.

Started

Apr 2025

Expected to finish

Feb 2027

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 to 75 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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

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Conditions

The condition(s) this trial relates to.

irritable bowel syndrome

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Irritable bowel syndrome

How to take part

Only the study team decides who joins. These are the ways to reach them.

The places running it

1 site. The list below names each one and where it is.
The official record

ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

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A doctor treating you

A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Could a simple supplement soothe IBS?

What the study statuses mean