Efficacy of a Low FODMAP Diet According to Colonic pH in Irritable Bowel Syndrome Patients

NCT ID: NCT05326646

Last Updated: 2024-12-17

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: NA
• Total Enrollment: 24 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-04-19
• Study Completion Date: 2024-02-15

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 microbiota differences is to assess its metabolic activity. It has been demonstrated that colonic pH in IBS patients is lower than in healthy volunteers, reflecting a highest colonic fermentation. Colonic acidification is able to sensitize colonic mechano-receptors to distension. Microbiota profile is able to predict the response to a low Fermentable Oligo, Di, Monosaccharides And Polyols (FODMAPs) diet, but is not available in clinical routine.

The aim of our study is to assess the link between colonic fermentation (measured by colonic pH) and the efficacy of a low FODMAPs diet in IBS patients (measured by IBS severity scoring system (IBS-SSS)). We hypothesis that IBS patients with a lower colonic pH will have a better efficacy of the low FODMAPs diet. It might allow in the future personalized medicine.

50 IBS patients according to Rome IV criteria will be included in our study. All patients will have a measure of their colonic pH by wireless motility capsule. Patients will follow a low FODMAPs diet for 6 weeks after an education by a trained dietician. All participants will fill validated questionnaires before and after 6 weeks of low FODMAPs diet: IBS-SSS, Gastro Intestinal Quality of Life Index (GIQLI), Hospital Anxiety and Depression (HAD) scale. Microbiota, metabolomic and short chain fatty acid will be analysed before and after the intervention. The number of patients was calculated to assess the correlation between colonic pH and the variation of IBS-SSS before and after the intervention.

Conditions

Irritable Bowel Syndrome

Keywords

Low FODMAP diet; predictive factor; colonic pH

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

IBS patients

Patients suffering from IBS according to Rome IV criteria

Group Type: EXPERIMENTAL

Low FODMAP diet

Intervention Type: DIETARY_SUPPLEMENT

After the realisation of a wireless motility capsule, patients will underwent 6 weeks of low FODMAP diet after dietician education. Symptomatic scores (IBS-SSS, GIQLI, HAD) and stools samples (metabolomic and lipidomic) will be performed before and after the low FODMAP diet.

Interventions

Low FODMAP diet

After the realisation of a wireless motility capsule, patients will underwent 6 weeks of low FODMAP diet after dietician education. Symptomatic scores (IBS-SSS, GIQLI, HAD) and stools samples (metabolomic and lipidomic) will be performed before and after the low FODMAP diet.

Intervention Type: DIETARY_SUPPLEMENT

Eligibility Criteria

Inclusion Criteria

• 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 Criteria

• 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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University Hospital, Rouen

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Chloé Melchior, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

University Hospital, Rouen

Locations

Rouen University Hospital

Rouen, , France

Countries

France

Other Identifiers

2019/0332/HP

Identifier Type: -

Identifier Source: org_study_id