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Trials / Recruiting

RecruitingNCT06291038

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

Efficacy of Glutamine Supplementation in Patients Suffering From Irritable Bowel

Status
Recruiting
Phase
N/A
Study type
Interventional
Enrollment
60 (estimated)
Sponsor
University Hospital, Rouen · Academic / Other
Sex
All
Age
18 Years – 75 Years
Healthy volunteers
Not accepted

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.

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.

Conditions

Interventions

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

Timeline

Start date
2024-10-03
Primary completion
2029-03-01
Completion
2029-03-01
First posted
2024-03-04
Last updated
2026-02-20

Locations

4 sites across 1 country: France

Source: ClinicalTrials.gov record NCT06291038. Inclusion in this directory is not an endorsement.