Status:
TERMINATED
Efficacy of a Low FODMAP Diet According to Colonic pH in Irritable Bowel Syndrome Patients
Lead Sponsor:
University Hospital, Rouen
Conditions:
Irritable Bowel Syndrome
Eligibility:
All Genders
18-80 years
Phase:
NA
Brief Summary
Treatments efficacy in irritable bowel syndrome (IBS) patients is inconstant and predictive factors of their efficacy are needed. The role of dysbiosis in IBS is well-known. Another way to identify mi...
Eligibility Criteria
Inclusion
- IBS according to Rome IV criteria
- Normal blood test (cell blood count, C Reactive Protein, thyroid-stimulating hormone, anti transglutaminase antibodies) in the last 12 months
- IBS severity score (IBS-SSS) \>175/500
- IBS treatments stable in the last month
- Effective contraception since 1 month for women in childbearing age
Exclusion
- Anorexia nervosa or any eating disorders deemed incompatible
- Organic gastroenterological diseases (inflammatory bowel disorder, microscopic colitis, gastrointestinal cancer, celiac disease)
- Contra-indication to the wireless motility capsule (intestinal stenosis, digestive fistula or obstruction, history of bezoar, gastrointestinal surgery in the last 3 months, acute diverticulitis, cardiac pacemaker, implanted electromedical device, magnetic resonance imaging planned in the 5 days after the wireless motility capsule, swallowing disorder)
- Breastfeeding or pregnant women
- Participation in another clinical trial in the last 2 weeks
- Patient who could not stop proton pump inhibitor treatment for 10 days
- Person with administrative or judicial decision or under legal protection measure
Key Trial Info
Start Date :
April 19 2023
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 15 2024
Estimated Enrollment :
24 Patients enrolled
Trial Details
Trial ID
NCT05326646
Start Date
April 19 2023
End Date
February 15 2024
Last Update
December 17 2024
Active Locations (1)
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1
Rouen University Hospital
Rouen, France, 76000