Effectiveness of a Dietary Supplement in Irritable Bowel Syndrome

NCT07039747 | Recruiting Phase 2

• 1 other identifier: 2024/0178/HP
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

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.

Conditions

Irritable Bowel Syndrome

Keywords

glutamine

Outcome Measures

Primary Outcomes (1)

• Symptomatic efficacy of DIELEN® Protect supplementation

  change in IBS severity score (IBS-SSS) measured before and after 8 weeks of DIELEN® Protect or placebo supplementation in patients The IBS-SSS is a questionnaire used to assess the severity of irritable bowel syndrome. Rated from 0 to 50, 50 is the worst case with a severe case

  from enrollment up to 8 weeks

Secondary Outcomes (8)

• impact of DIELEN® Protect on the composition of the intestinal microbiota

  from enrollment up to 8 weeks

• Impact of DIELEN® Protect on quality of life

  from enrollment up to 8 weeks

• impact of DIELEN® Protect on gastrointestinal related anxiety

  from enrollment up yto 8 weeks

• impact of DIELEN® Protect on anxiety and/or depression

  from enrollment up to 8 weeks

• impact of DIELEN® Protect on stool frequency

  from enrollment up to 8 weeks

Study Arms (2)

treatment with DIELEN® Protect

EXPERIMENTAL

experimental group: treatment with DIELEN® Protect for 8 weeks at a dose of 5 grams, 3x a day

Drug: treatment with DIELEN® Protect

control group

PLACEBO COMPARATOR

Control group: treatment with placebo (pea protein) for 8 weeks at a dose of 5 grams, 3x a day

Drug: treatment with placebo of DIELEN® Protect

Interventions

treatment with DIELEN® Protect DRUG

treatment with DIELEN® Protect for 8 weeks at a dose of 5 grams, 3x a day

Also known as: Dielen

treatment with DIELEN® Protect

treatment with placebo of DIELEN® Protect DRUG

treatment with placebo of DIELEN® Protect for 8 weeks at a dose of 5 grams, 3x a day

Also known as: placebo

control group

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Irritable bowel syndrome according to Rome IV criteria
• Aged between 18 and 75 years
• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University Hospital, Rouen: lead
• Laboratoire Dielen: collaborator

Study Sites (1)

CHU de Rouen

Rouen, France, France

RECRUITING

MeSH Terms

Conditions

Irritable Bowel Syndrome

Interventions

Therapeutics

Condition Hierarchy (Ancestors)

Colonic Diseases, Functional; Colonic Diseases; Intestinal Diseases; Gastrointestinal Diseases; Digestive System Diseases

Study Officials

• Chloé MELCHIOR, PUPH

  University Hospital, Rouen

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Chloé MELCHIOR, PUPH

CONTACT

00332 32 88 67 07; Chloe.Melchior@chu-rouen.fr

Mylene HERVET

CONTACT

mylene.hervet@chu-rouen.fr

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 18, 2025
• First Posted: June 26, 2025
• Study Start: April 22, 2025
• Primary Completion (Estimated): February 1, 2027
• Study Completion (Estimated): February 1, 2027
• Last Updated: February 23, 2026

Record last verified: 2025-06

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)