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Recruiting NCT06291038

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

No phase Interventional Irritable Bowel Syndrome

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: • 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..
Who it may be relevant to
Registry conditions: Irritable Bowel Syndrome. Basic parameters: 18 years — 75 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
France
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

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Official title

Efficacy of Glutamine Supplementation in Patients Suffering From Irritable Bowel

Overview

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.

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.

Primary outcome measures

  • Evaluate the symptomatic effectiveness of glutamine supplementation in patients suffering from IBS-D with increased intestinal permeability [Time frame: 8 weeks]

Eligibility criteria

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Single blind
Primary purpose
Treatment

Study locations

France · 4 centers
  • Chu Amiens — Amiens
  • CHU CAEN — Caen
  • Ch Le Havre — Le Havre
  • Chu Rouen — Rouen

Identifiers

NCT: NCT06291038 · 2021/0381/HP

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗