Last updated: February 26, 2024
Sponsor: University Hospital, Rouen
Overall Status: Active - Not Recruiting
Phase
N/A
Condition
Colic
Lactose Intolerance
Gastrointestinal Diseases And Disorders
Treatment
• 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.
Clinical Study ID
NCT06291038
2021/0381/HP
Ages 18-75 All Genders
Study Summary
Eligibility Criteria
Inclusion
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 consentform
- Woman of childbearing age having effective/very effective contraception (Cf. CTFG) (estrogen-progestins or intrauterine device or tubal ligation) for 1 month and anegative urine pregnancy test
- Postmenopausal woman: confirmatory diagnosis (amenorrhea not medically induced for atleast 12 months before the inclusion visit or biologically documented)
Exclusion
Exclusion Criteria:
- Taking probiotics, anti-inflammatories, corticosteroids or antibiotics systemically (oral or injectable) in the month preceding the study and during the duration of thestudy treatment,
- Known diagnosis of active autoimmune disease (type 1 diabetes, lupus, multiplesclerosis, thyroiditis, ankylosing spondylitis, rheumatoid arthritis or psoriasis)
- Known allergy to glutamine,
- Contraindication to taking glutamine, protein powder, lactulose or mannitol (includingsugar-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 heartdisease,
- 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 placedunder judicial protection/under guardianship or curatorship,
- Person participating in research participating in another trial / having participatedin another trial within 2 weeks,
- History of illness or psychological or sensory abnormality likely to prevent thesubject from fully understanding the conditions required for participation in theprotocol or preventing them from giving informed consent.
Study Design
Total Participants: 60
Treatment Group(s): 2
Primary Treatment: • Experimental group: treatment with glutamine at a dose of 5g 3 times a day for 8 weeks
Phase:
Study Start date:
July 01, 2024
Estimated Completion Date:
March 01, 2029