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

NCT05326646 | Terminated

• 1 other identifier: 2019/0332/HP
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (1)

• Correlation between efficacy of the low FODMAP diet on severity and the colonic pH

  Correlation between colonic pH (baseline) and the variation of IBS severity score (IBS-SSS). IBS-SSS is a score between 0 (no symptom) to 500 (highest symptom level).

  6 weeks

Secondary Outcomes (18)

• Correlation between efficacy of the low FODMAP diet on quality of life and the colonic pH

  6 weeks

• Correlation between efficacy of the low FODMAP diet on stool frequency and the colonic pH

  6 weeks

• Correlation between efficacy of the low FODMAP diet on stool consistency and the colonic pH

  6 weeks

• Correlation between efficacy of the low FODMAP diet on anxiety and the colonic pH

  6 weeks

• Correlation between efficacy of the low FODMAP diet on depression and the colonic pH

  6 weeks

Study Arms (1)

IBS patients

EXPERIMENTAL

Patients suffering from IBS according to Rome IV criteria

Dietary Supplement: Low FODMAP diet

Interventions

Low FODMAP diet 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.

IBS patients

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University Hospital, Rouen: lead

Study Sites (1)

Rouen University Hospital

Rouen, 76000, France

Location

MeSH Terms

Conditions

Irritable Bowel Syndrome

Interventions

FODMAP Diet

Condition Hierarchy (Ancestors)

Colonic Diseases, Functional; Colonic Diseases; Intestinal Diseases; Gastrointestinal Diseases; Digestive System Diseases

Intervention Hierarchy (Ancestors)

Elimination Diets; Diet; Nutritional Physiological Phenomena; Diet, Food, and Nutrition; Physiological Phenomena

Study Officials

• Chloé Melchior, MD, PhD

  University Hospital, Rouen

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 8, 2021
• First Posted: April 13, 2022
• Study Start: April 19, 2023
• Primary Completion: February 15, 2024
• Study Completion: February 15, 2024
• Last Updated: December 17, 2024

Record last verified: 2024-12

Locations

FR (1)