Glutamine to improve the gut lining in people with diarrhea-predominant IBS and increased intestinal permeability

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

Adults with IBS-D and documented increased intestinal permeability (measured by the lactulose/mannitol test) are enrolled and receive either glutamine 5 g three times daily or a protein powder placebo 5 g three times daily for eight weeks. The trial compares symptom measures (including abdominal pain and overall IBS severity) and changes in intestinal permeability before and after treatment. Eligible participants are 18–75 years old with moderate to severe IBS-D (Francis score greater than 175) and stable IBS treatments for at least one month. Concomitant recent use of probiotics, systemic antibiotics, corticosteroids or anti-inflammatories and certain active autoimmune diagnoses are exclusion criteria.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* Adult aged 18 to 75
* Diarrheal irritable bowel syndrome (IBS-D), according to the Rome IV criteria (appendix 2)
* Francis score \> 175/500 at inclusion (corresponding to moderate to severe IBS)
* Treatments for IBS stable for \>1 month
* Affiliation to a social security system
* Adult person having read and understood the information letter and signed the consent form
* Woman of childbearing age having effective/very effective contraception (Cf. CTFG) (estrogen-progestins or intrauterine device or tubal ligation) for 1 month and a negative urine pregnancy test
* Postmenopausal woman: confirmatory diagnosis (amenorrhea not medically induced for at least 12 months before the inclusion visit or biologically documented)

Exclusion Criteria:

* Taking probiotics, anti-inflammatories, corticosteroids or antibiotics systemically (oral or injectable) in the month preceding the study and during the duration of the study treatment,
* Known diagnosis of active autoimmune disease (type 1 diabetes, lupus, multiple sclerosis, thyroiditis, ankylosing spondylitis, rheumatoid arthritis or psoriasis)
* Known allergy to glutamine,
* Contraindication to taking glutamine, protein powder, lactulose or mannitol (including sugar-free chewing gum),
* Use of osmotic laxatives and/or taking lactulose and/or protein supplementation (including taking glutamine) in the 4 weeks preceding the start of the study,
* Renal insufficiency (GFR\<40mL/min), hepatic insufficiency (PT\<70) or known heart disease,
* ATCD of digestive disease (celiac disease, chronic inflammatory bowel disease, abdominal surgery other than appendectomy or cholecystectomy),
* Occlusive or subocclusive syndrome,
* Digestive perforation or suspicion of perforation,
* Abdominal pain syndrome of undetermined cause,
* Chronic alcohol consumption (\>14 units/week),
* Pregnant or parturient or breastfeeding woman or proven absence of contraception,
* Person deprived of liberty by an administrative or judicial decision or person placed under judicial protection/under guardianship or curatorship,
* Person participating in research participating in another trial / having participated in another trial within 2 weeks,
* History of illness or psychological or sensory abnormality likely to prevent the subject from fully understanding the conditions required for participation in the protocol or preventing them from giving informed consent.

Where it's running

• Chu Caen
  Caen, France Recruiting
• Ch Le Havre
  Le Havre, France Recruiting
• Chu Rouen
  Rouen, France Recruiting
• Chu Amiens
  Amiens, France Not yet recruiting

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.