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

Irritable Bowel Syndrome Clinical Trial

— MISSISIIPI  

Official title:

Efficacy of Glutamine Supplementation in Patients Suffering From Irritable Bowel

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06291038
• Other study ID #: 2021/0381/HP
• Status: Not yet recruiting
• Phase: N/A
• Start date: July 1, 2024
• Est. completion date: March 1, 2029

Study information

• Verified date: February 2024
• Source: University Hospital, Rouen
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 60
• Est. completion date: March 1, 2029
• Est. primary completion date: March 1, 2029
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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.

Related Conditions & MeSH terms

• Irritable Bowel Syndrome
• Syndrome

Intervention

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
• • 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.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Rouen

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Evaluate the symptomatic effectiveness of glutamine supplementation in patients suffering from IBS-D with increased intestinal permeability	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.	8 weeks