Clinical trial NCT05326646: Efficacy of a Low FODMAP Diet According to Colonic pH in Irritable Bowel Syndrome Patients
Official title: Efficacy of a Low FODMAP Diet According to Colonic pH Measured by Wireless Motility Capsule in Irritable Bowel Syndrome Patients
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Irritable Bowel Syndrome
Keywords: Low FODMAP diet
predictive factor
colonic pH
Lead sponsor: University Hospital, Rouen
Sponsor class: OTHER
First posted: 2022-04-13
Enrollment: 24
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.


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

Primary outcomes:
measure: Correlation between efficacy of the low FODMAP diet on severity and the colonic pH
timeFrame: 6 weeks
Secondary outcomes:
measure: Correlation between efficacy of the low FODMAP diet on quality of life and the colonic pH
timeFrame: 6 weeks
measure: Correlation between efficacy of the low FODMAP diet on stool frequency and the colonic pH
timeFrame: 6 weeks
measure: Correlation between efficacy of the low FODMAP diet on stool consistency and the colonic pH
timeFrame: 6 weeks
measure: Correlation between efficacy of the low FODMAP diet on anxiety and the colonic pH
timeFrame: 6 weeks
measure: Correlation between efficacy of the low FODMAP diet on depression and the colonic pH
timeFrame: 6 weeks
measure: Correlation between short chain fatty acids and the colonic pH
timeFrame: 6 weeks
measure: Correlation between metabolites and the colonic pH
timeFrame: 6 weeks
measure: Colonic pH according to small intestinal bacterial overgrowth
timeFrame: baseline
measure: Colonic pH according to fructose malabsorption
timeFrame: baseline
measure: Colonic pH according to visceral hypersensitivity
timeFrame: Baseline
measure: Colonic pH and fecal calprotectin
timeFrame: Baseline
measure: Colonic pH and rectal pain threshold
timeFrame: Baseline
measure: Correlation between baseline QOL and the colonic pH
timeFrame: Baseline
measure: Correlation between baseline IBS severity score and colonic pH
timeFrame: Baseline
measure: Correlation between baseline anxiety and colonic pH
timeFrame: Baseline
measure: Correlation between baseline depression and colonic pH
timeFrame: Baseline
measure: Correlation between baseline stool consistency and colonic pH
timeFrame: Baseline
measure: Correlation between baseline stool frequency and colonic pH
timeFrame: Baseline
Other outcomes:
Locations:
city: Rouen
country: France
facility: Rouen University Hospital
Study officials:
affiliation: University Hospital, Rouen
name: Chloé Melchior, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: