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Taking people in FranceNo phase

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

Key facts

Who runs it
University Hospital, Rouen
Where
Amiens, Caen, Le Havre, and Rouen, FranceSee the 4 sites
Trial code
Status
Recruiting
People taking part
60 people, planned
Started
3 Oct 2024
Expected to end
1 Mar 2029
Type of study
Interventional, 2 groupsOne group gets a placebo (a dummy treatment), for comparison.
Treatments tested
  • • Experimental group: treatment with glutamine at a dose of 5g 3 times a day for 8 weeks
  • • Control group: treatment with a protein powder (Protifar) (Placébo) 5g 3 times a day for 8 weeks.
Record updated
20 February 2026

Who can take part

Age
18 years to 75 years
Sex
Women and men
Healthy volunteers
Cannot take part

The registry criteria, word for word

Show all 23 criteriaShow less

Who can take part

  • 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)

Who cannot take part

  • 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,
  • 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,
  • 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
  • Renal insufficiency (GFR<40mL/min), hepatic insufficiency (PT<70) or known heart disease,
  • 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,
  • 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,

Check if you might fit

Answer for yourself. This is not a decision: only the study team can say whether you can take part.

  • Are you between 18 and 75 years old?

Where in France

  • CHU AmiensAmiens, FranceContact: Céline LedouxNot yet recruiting
  • CHU CaenCaen, FranceContact: Arnaud LerouxTaking people
  • Ch Le HavreLe Havre, FranceContact: Angelique PicardTaking people
  • CHU RouenRouen, FranceContact: Chloe Melchior, DrTaking people

About the trial

What the trial wants to find out

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.

Read full original descriptionShow less

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.

The 2 groups in the trial

  • GlutamineTreatment being tested

    • Experimental group: treatment with glutamine at a dose of 5g 3 times a day for 8 weeks.

    Treatment: • Experimental group: treatment with glutamine at a dose of 5g 3 times a day for 8 weeks

  • ProtifarPlacebo, for comparison

    • Control group: treatment with a protein powder (Protifar) (Placébo) 5g 3 times a day for 8 weeks.

    Treatment: • Control group: treatment with a protein powder (Protifar) (Placébo) 5g 3 times a day for 8 weeks.

Questions to ask the study team

  1. How often do I need to come in, and for how long each time?
  2. Are travel costs paid?
  3. Can I keep my own doctor?
  4. What happens if I want to stop?

Contact the study team: see the registry record → Contacts and Locations

Print a page for my doctor

Data and sources

Registry record
Listed on ClinicalTrials.gov.
Official title
Efficacy of Glutamine Supplementation in Patients Suffering From Irritable Bowel
Fit questions
Built from NCT06291038, who can take part
Record updated
20 February 2026