Actively Recruiting

Phase Not Applicable
Age: 18Years - 75Years
All Genders
NCT06291038

Efficacy of Glutamine Supplementation in Patients Suffering From Irritable Bowel Syndrome With Impaired Intestinal Permeability

Led by University Hospital, Rouen · Updated on 2026-02-20

60

Participants Needed

4

Research Sites

230 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

Irritable bowel syndrome (IBS) affects approximately 5% of the general population and remains a daily problem in the practice of clinicians with inconsistent effectiveness of treatments while patients' expectations are high. One of the functional abnormalities described during IBS is increased intestinal permeability. This increase in intestinal permeability is primarily present in the diarrheal subtype (IBS-D) and can be measured using the lactulose/mannitol test. Glutamine is a non-essential amino acid which regulates numerous metabolic pathways, and which plays a key role in the intestine because it is the preferential substrate of enterocytes and immune cells. Ex vivo, glutamine is able to restore the expression of tight junction proteins in patients suffering from IBS-D. On the other hand, glutamine supplementation is capable of reducing abdominal pain and restoring intestinal permeability disorders in a subgroup of patients with intestinal permeability disorder (post-infectious IBS-D). The working hypothesis would be that all patients suffering from IBS with permeability disorder, measured by the lactulose/mannitol test, could benefit from oral glutamine supplementation.

CONDITIONS

Official Title

Efficacy of Glutamine Supplementation in Patients Suffering From Irritable Bowel Syndrome With Impaired Intestinal Permeability

Who Can Participate

Age: 18Years - 75Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Adult aged 18 to 75
  • Diagnosed with diarrheal irritable bowel syndrome (IBS-D) according to Rome IV criteria
  • Francis score greater than 175 out of 500 at inclusion indicating moderate to severe IBS
  • Stable IBS treatments for more than 1 month
  • Affiliated with a social security system
  • Able to read, understand the information, and sign the consent form
  • Women of childbearing age must use effective contraception for at least 1 month and have a negative urine pregnancy test
  • Postmenopausal women must have confirmed diagnosis with at least 12 months of natural amenorrhea or biological confirmation
Not Eligible

You will not qualify if you...

  • Use of probiotics, anti-inflammatories, corticosteroids, or antibiotics within 1 month before or during the study
  • Known active autoimmune diseases such as type 1 diabetes, lupus, multiple sclerosis, thyroiditis, ankylosing spondylitis, rheumatoid arthritis, or psoriasis
  • Known allergy to glutamine
  • Contraindications to glutamine, protein powder, lactulose, or mannitol (including sugar-free chewing gum)
  • Use of osmotic laxatives, lactulose, or protein supplements including glutamine within 4 weeks before study start
  • Renal insufficiency with GFR less than 40 mL/min, hepatic insufficiency with PT less than 70, or known heart disease
  • History of digestive diseases like celiac disease, chronic inflammatory bowel disease, or abdominal surgery other than appendectomy or cholecystectomy
  • Presence of occlusive or subocclusive syndrome
  • Digestive perforation or suspicion of perforation
  • Abdominal pain syndrome without known cause
  • Chronic alcohol consumption over 14 units per week
  • Pregnancy, breastfeeding, or lack of effective contraception
  • Legal restrictions such as being deprived of liberty or under judicial protection
  • Participation in another clinical trial within the last 2 weeks
  • Psychological, sensory, or illness history that prevents understanding or consenting to study participation

AI-Screening

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Trial Site Locations

Total: 4 locations

1

Chu Amiens

Amiens, France, 80054

Not Yet Recruiting

2

CHU CAEN

Caen, France, 14033

Actively Recruiting

3

Ch Le Havre

Le Havre, France, 76290

Actively Recruiting

4

Chu Rouen

Rouen, France, 76031

Actively Recruiting

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How is the study designed?

Study Type

INTERVENTIONAL

Masking

SINGLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

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Efficacy of Glutamine Supplementation in Patients Suffering From Irritable Bowel Syndrome With Impaired Intestinal Permeability | DecenTrialz