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RecruitingNCT06291038MISSISIIPIUpdated Feb 20, 2026

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

An interventional study of • Experimental group: treatment with glutamine at a dose of 5g 3 times a day for 8 weeks and • Control group: treatment with a protein powder (Protifar) (Placébo) 5g 3 times a day for 8 weeks. in Irritable Bowel Syndrome, sponsored by University Hospital, Rouen. Recruiting at 4 sites in France. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2026-02-20.

Sponsored by University Hospital, Rouen · Not applicable, Interventional, and Treatment

From the registry’s dates

  • Started Oct 2024; still recruiting 2 years later.
Phase
Not applicable
Study type
Interventional
Enrollment
60
Allocation
Randomized
Ages
18 Years to 75 Years
Sex
All
01

Study summary

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.

Read the detailed description

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.

02

Conditions studied

  • Irritable Bowel Syndrome
03

In context

Irritable Bowel Syndrome

1,062 studies on the registry are indexed under Irritable Bowel Syndrome; 190 are open to participants now.

This study's planned enrollment of 60 is below the median of 71 across 853 interventional studies indexed under Irritable Bowel Syndrome.

Browse Irritable Bowel Syndrome studies →

Lead sponsor

University Hospital, Rouen is the lead sponsor of 410 studies on the registry; 104 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 75 Years
Sexes eligible
All
Accepts healthy volunteers
No

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

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.
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Participant)
Enrollment
60 participants (estimated)

Study arms

  • Experimental
    Glutamine

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

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

  • Placebo comparator
    Protifar

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

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

Interventions

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

    treatment with glutamine at a dose of 5g 3 times a day for 8 weeks

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

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

06

What researchers measure

Primary outcomes

  1. Evaluate the symptomatic effectiveness of glutamine supplementation in patients suffering from IBS-D with increased intestinal permeability

    the change in Francis score measured before and after glutamine or placebo supplementation for 8 weeks in patients suffering from IBS-D with increased intestinal permeability. Rated from 0 et 500, 500 is the worst case with a severe form

    Time frame: 8 weeks

07

Study locations

3 of 4 sites recruiting
  • Chu Amiens
    Amiens, 80054, France
    Not yet recruiting
  • CHU CAEN
    Caen, 14033, France
    Recruiting
  • Ch Le Havre
    Le Havre, 76290, France
    Recruiting
  • Chu Rouen
    Rouen, 76031, France
    Recruiting
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Feb 20, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT06291038
Lead sponsor
University Hospital, Rouen
Responsible party
Sponsor
First posted
Mar 4, 2024
Start date
Oct 3, 2024
Primary completion
Mar 1, 2029 (estimated)
Completion
Mar 1, 2029 (estimated)
Last update
Feb 20, 2026

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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