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

February 17, 2026 updated by: University Hospital, Rouen

Efficacy of Glutamine Supplementation in Patients Suffering From Irritable Bowel

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Estimated)

60

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Amiens, France, 80054
      • Caen, France, 14033
        • Recruiting
        • CHU Caen
        • Sub-Investigator:
          • Marie-Astrid Piquet, Pr
        • Contact:
      • Le Havre, France, 76290
        • Recruiting
        • Ch Le Havre
        • Contact:
        • Sub-Investigator:
          • Caroline Lemaitre, Dr
      • Rouen, France, 76031
        • Recruiting
        • CHU Rouen
        • Contact:
        • Principal Investigator:
          • Chloe Melchior, Dr

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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
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.
treatment with a protein powder (Protifar) (Placébo) 5g 3 times a day for 8 weeks.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Evaluate the symptomatic effectiveness of glutamine supplementation in patients suffering from IBS-D with increased intestinal permeability
Time Frame: 8 weeks
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
8 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospital, Rouen

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 3, 2024

Primary Completion (Estimated)

March 1, 2029

Study Completion (Estimated)

March 1, 2029

Study Registration Dates

First Submitted

February 26, 2024

First Submitted That Met QC Criteria

February 26, 2024

First Posted (Actual)

March 4, 2024

Study Record Updates

Last Update Posted (Actual)

February 20, 2026

Last Update Submitted That Met QC Criteria

February 17, 2026

Last Verified

February 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2021/0381/HP

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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