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

Irritable Bowel Syndrome Clinical Trial

— FOSIIL  

Official title:

Efficacy of a Low FODMAP Diet According to Colonic pH Measured by Wireless Motility Capsule in Irritable Bowel Syndrome Patients

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05326646
• Other study ID #: 2019/0332/HP
• Status: Recruiting
• Phase: N/A
• Start date: April 19, 2023
• Est. completion date: August 2024

Study information

• Verified date: May 2023
• Source: University Hospital, Rouen
• Contact: Chloé Melchior, MD, PhD
• Phone: 0033232886707
• Email: chloe.melchior[@]chu-rouen.fr
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 50
• Est. completion date: August 2024
• Est. primary completion date: August 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Irritable Bowel Syndrome
• Syndrome

Intervention

Dietary Supplement:
• 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.

Locations

Country	Name	City	State
France	Rouen University Hospital	Rouen

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Rouen

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Correlation between efficacy of the low FODMAP diet on quality of life and the colonic pH	Correlation between colonic pH (baseline) and variation of the quality of life Index (GIQLI). GIQLI is a score between 0 (lowest quality of life) and 144 (best quality of life).	6 weeks
Secondary	Correlation between efficacy of the low FODMAP diet on stool frequency and the colonic pH	Correlation between colonic pH (baseline) and variation of the stool frequency	6 weeks
Secondary	Correlation between efficacy of the low FODMAP diet on stool consistency and the colonic pH	Correlation between colonic pH (baseline) and variation of the stool consistency (BSF)	6 weeks
Secondary	Correlation between efficacy of the low FODMAP diet on anxiety and the colonic pH	Correlation between colonic pH (baseline) and variation of anxiety (HAD). HAD anxiety is a scale comprised between 0 (no anxiety) and 21 (highest anxiety).	6 weeks
Secondary	Correlation between efficacy of the low FODMAP diet on depression and the colonic pH	Correlation between colonic pH (baseline) and variation of depression (HAD). HAD depression is a scale comprised between 0 (no depression) and 21 (highest depression).	6 weeks
Secondary	Correlation between short chain fatty acids and the colonic pH	Correlation between colonic pH (baseline) and variation of short chain fatty acids (in the stool)	6 weeks
Secondary	Correlation between metabolites and the colonic pH	Correlation between colonic pH (baseline) and variation of metabolites (in the stool). Among metabolites, short chain fatty acids, 28 biliary acids and lipopeptides (C12-GABA, C12-Glutamine, C14-Glutamine, C15-GABA, C16-Glutamate, C16-Glutamine, C18-GABA, C12:1-Alanine (Ala)-GABA, C12-Ala-GABA, C13-Ala-GABA, C14:1-Ala-GABA et C183OH-Glutamate-GABA) will be assessed. Metabolites will be also assessed by RMN spectroscopy that allow the assessment of a high ranges of different metabolites.	6 weeks
Secondary	Colonic pH according to small intestinal bacterial overgrowth	Comparison of colonic pH between patients with and without small intestinal bacterial overgrowth	baseline
Secondary	Colonic pH according to fructose malabsorption	Comparison of colonic pH between patients with and without fructose malabsorption	baseline
Secondary	Colonic pH according to visceral hypersensitivity	Comparison of colonic pH between patients with and without visceral hypersensitivity	Baseline
Secondary	Colonic pH and fecal calprotectin	Correlation between colonic pH and fecal calprotectin	Baseline
Secondary	Colonic pH and rectal pain threshold	Correlation between colonic pH and rectal pain threshold	Baseline
Secondary	Correlation between baseline QOL and the colonic pH	Correlation between colonic pH and baseline GIQLI (quality of life Index)	Baseline
Secondary	Correlation between baseline IBS severity score and colonic pH	Correlation between colonic pH and baseline IBS severity score (IBS-SSS)	Baseline
Secondary	Correlation between baseline anxiety and colonic pH	Correlation between colonic pH and baseline anxiety (HAD)	Baseline
Secondary	Correlation between baseline depression and colonic pH	Correlation between colonic pH and baseline depression (HAD)	Baseline
Secondary	Correlation between baseline stool consistency and colonic pH	Correlation between baseline stool consistency (BSF) and colonic pH	Baseline
Secondary	Correlation between baseline stool frequency and colonic pH	Correlation between baseline stool frequency and colonic pH	Baseline