Irritable Bowel Syndrome (IBS) Clinical Trials

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Efficacy of Glutamine Supplementation in Patients Suffering From Irritable Bowel

Status: Recruiting
Location: See all (4) locations...
Intervention Type: Dietary supplement
Study Type: Interventional
Study Phase: Not Applicable
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 75
Healthy Volunteers: f
View:

• 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)

Locations
Other Locations
France
Chu Amiens
NOT_YET_RECRUITING
Amiens
CHU CAEN
RECRUITING
Caen
Ch Le Havre
RECRUITING
Le Havre
Chu Rouen
RECRUITING
Rouen
Time Frame
Start Date: 2024-10-03
Estimated Completion Date: 2029-03-01
Participants
Target number of participants: 60
Treatments
Experimental: Glutamine
• 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.
Related Therapeutic Areas
Sponsors
Leads: University Hospital, Rouen

This content was sourced from clinicaltrials.gov