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

NCT ID: NCT06291038

Last Updated: 2024-03-04

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-07-01
• Study Completion Date: 2029-03-01

Brief 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).

Our 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).

Our 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

Irritable Bowel Syndrome

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Glutamine

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

Group Type: EXPERIMENTAL

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

Intervention Type: DIETARY_SUPPLEMENT

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

Protifar

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

Group Type: PLACEBO_COMPARATOR

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

Intervention Type: DIETARY_SUPPLEMENT

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

Interventions

• 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

Intervention Type: 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.

Intervention Type: DIETARY_SUPPLEMENT

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University Hospital, Rouen

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Other Identifiers

2021/0381/HP

Identifier Type: -

Identifier Source: org_study_id