Effectiveness of a Dietary Supplement in Irritable Bowel Syndrome

Launched by UNIVERSITY HOSPITAL, ROUEN · Jun 18, 2025

Keywords

ClinConnect Summary

This clinical trial is studying whether a new dietary supplement called DIELEN Protect can help people with moderate to severe irritable bowel syndrome (IBS), a common condition that causes stomach pain, changes in bowel habits, and affects quality of life. The supplement combines two ingredients—glutamine, a natural amino acid that supports gut health, and marine peptides that may reduce inflammation and improve gut barrier function. Researchers hope this combination will reduce IBS symptoms like abdominal pain and improve overall well-being.

The study is looking for adults aged 18 to 75 who have IBS diagnosed by standard criteria and who experience significant symptoms. If you join, you will take either the DIELEN Protect supplement or a placebo (a look-alike pill with no active ingredients) every day for 8 weeks. Before and after treatment, you’ll complete questionnaires about your IBS symptoms, quality of life, anxiety, and bowel habits. The study will also analyze samples to understand how the supplement might affect gut bacteria and other markers. People currently taking probiotics, antibiotics, or certain supplements, as well as those with allergies to fish or glutamine, serious health conditions, or who are pregnant or breastfeeding, cannot take part. This trial aims to find a safe and effective way to help people living with IBS feel better.

Gender

ALL

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