Irritable Bowel SyndromeFOSIILNCT05326646
Efficacy of a Low FODMAP Diet According to Colonic pH in Irritable Bowel Syndrome Patients
A study testing Low FODMAP diet in people with Irritable Bowel Syndrome, run by University Hospital, Rouen at 1 site in France.
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. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Irritable Bowel Syndrome
- What is being tested?
- Low FODMAP diet
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 1 siteFrance
- Study dates
- 19 Apr 2023to 15 Feb 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Efficacy of a Low FODMAP Diet According to Colonic pH Measured by Wireless Motility Capsule in Irritable Bowel Syndrome Patients
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
- Being tested
- Low FODMAP diet
- Keywords
- Low FODMAP diet, predictive factor, colonic pH
- Medical subject headings
- Irritable Bowel Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Low FODMAP dietDietary 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.
| Study group | Role | What they receive |
|---|---|---|
| IBS patients | Experimental | Patients suffering from IBS according to Rome IV criteria Receives: Dietary Supplement: Low FODMAP diet |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 6 weeks
Secondary outcomes (18)
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).
Measured: 6 weeks
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
Measured: 6 weeks
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)
Measured: 6 weeks
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).
Measured: 6 weeks
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).
Measured: 6 weeks
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)
Measured: 6 weeks
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.
Measured: 6 weeks
Colonic pH according to small intestinal bacterial overgrowth
Comparison of colonic pH between patients with and without small intestinal bacterial overgrowth
Measured: baseline
Colonic pH according to fructose malabsorption
Comparison of colonic pH between patients with and without fructose malabsorption
Measured: baseline
Colonic pH according to visceral hypersensitivity
Comparison of colonic pH between patients with and without visceral hypersensitivity
Measured: Baseline
Colonic pH and fecal calprotectin
Correlation between colonic pH and fecal calprotectin
Measured: Baseline
Colonic pH and rectal pain threshold
Correlation between colonic pH and rectal pain threshold
Measured: Baseline
Correlation between baseline QOL and the colonic pH
Correlation between colonic pH and baseline GIQLI (quality of life Index)
Measured: Baseline
Correlation between baseline IBS severity score and colonic pH
Correlation between colonic pH and baseline IBS severity score (IBS-SSS)
Measured: Baseline
Correlation between baseline anxiety and colonic pH
Correlation between colonic pH and baseline anxiety (HAD)
Measured: Baseline
Correlation between baseline depression and colonic pH
Correlation between colonic pH and baseline depression (HAD)
Measured: Baseline
Correlation between baseline stool consistency and colonic pH
Correlation between baseline stool consistency (BSF) and colonic pH
Measured: Baseline
Correlation between baseline stool frequency and colonic pH
Correlation between baseline stool frequency and colonic pH
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Apr 2022
- Study start19 Apr 2023
- Primary completion15 Feb 2024
- Study completion15 Feb 2024
Why it stopped: The Medical Device (SmartPill) used in this project is no longer on the market
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Irritable Bowel SyndromeStudies of the same condition, open and under way.
- More trials run by University Hospital, RouenThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Rouen
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Chloé Melchior, MD, PhD, Principal investigator, University Hospital, Rouen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05326646
- Sponsor's protocol ID
- 2019/0332/HP
- Acronym
- FOSIIL
- Status last verified
- Dec 2024
- First submitted
- 8 Dec 2021
- Last updated
- 17 Dec 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: upon request
Study at a glance
From the registry record, last updated by the sponsor on 17 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of a Low FODMAP Diet According to Colonic pH Measured by Wireless Motility Capsule in Irritable Bowel Syndrome Patients
- ClinicalTrials.gov ID
- NCT05326646
- Acronym / sponsor ID
- FOSIIL / 2019/0332/HP
- Conditions
- Irritable Bowel Syndrome
- Keywords
- Low FODMAP diet, predictive factor, colonic pH
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: The Medical Device (SmartPill) used in this project is no longer on the market
- Enrolment
- 24 participants (actual)
- Lead sponsor
- University Hospital, RouenUniversity, hospital or other
- Study start
- 19 Apr 2023 (actual)
- Primary completion
- 15 Feb 2024 (actual)
- Study completion
- 15 Feb 2024 (actual)
- First posted
- 13 Apr 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| IBS patients | Experimental | Dietary Supplement: Low FODMAP dietPatients suffering from IBS according to Rome IV criteria |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Low FODMAP dietAfter 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. | Dietary supplement | IBS patients |
Primary outcome
Correlation between efficacy of the low FODMAP diet on severity and the colonic pH
Time frame: 6 weeks
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).
18 secondary outcomes
Correlation between efficacy of the low FODMAP diet on quality of life and the colonic pH
Time frame: 6 weeks
Correlation between efficacy of the low FODMAP diet on stool frequency and the colonic pH
Time frame: 6 weeks
Correlation between efficacy of the low FODMAP diet on stool consistency and the colonic pH
Time frame: 6 weeks
Correlation between efficacy of the low FODMAP diet on anxiety and the colonic pH
Time frame: 6 weeks
Correlation between efficacy of the low FODMAP diet on depression and the colonic pH
Time frame: 6 weeks
Correlation between short chain fatty acids and the colonic pH
Time frame: 6 weeks
Correlation between metabolites and the colonic pH
Time frame: 6 weeks
Colonic pH according to small intestinal bacterial overgrowth
Time frame: baseline
Colonic pH according to fructose malabsorption
Time frame: baseline
Colonic pH according to visceral hypersensitivity
Time frame: Baseline
Colonic pH and fecal calprotectin
Time frame: Baseline
Colonic pH and rectal pain threshold
Time frame: Baseline
Correlation between baseline QOL and the colonic pH
Time frame: Baseline
Correlation between baseline IBS severity score and colonic pH
Time frame: Baseline
Correlation between baseline anxiety and colonic pH
Time frame: Baseline
Correlation between baseline depression and colonic pH
Time frame: Baseline
Correlation between baseline stool consistency and colonic pH
Time frame: Baseline
Correlation between baseline stool frequency and colonic pH
Time frame: Baseline
Results and safety
The study was stopped early (reason given: The Medical Device (SmartPill) used in this project is no longer on the market). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Dec 2024.
- Individual participant dataSharing planned: Undecided. upon request
Related trials for Irritable Bowel Syndrome
RecruitingObservational study
Abdominal Symptoms and Rosacea: An Observational Study on the Association Between Irritable Bowel Syndrome (IBS) and the Gut-Skin Axis
IBS (Irritable Bowel Syndrome), Rosacea
Recruiting
Stress Reduction and Lifestyle Modification in Irritable Bowel Syndrome Patients
Irritable Bowel Syndrome
Recruiting
Exercise Interventions and Dietary Advice in Fibromyalgia and IBS
Fibromyalgia, Irritable Bowel Syndrome
RecruitingPhase 2
A Study of Brenipatide (LY3537031) in Participants With Irritable Bowel Syndrome-Constipation (IBS-C)
Irritable Bowel Syndrome, Constipation
RecruitingPhase 2
A Study of Brenipatide (LY3537031) in Participants With Irritable Bowel Syndrome-Diarrhea (IBS-D)
Irritable Bowel Syndrome, Diarrhea
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Chloé Melchior, MD, PhD principal investigator
University Hospital, Rouen
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Low FODMAP diet in people with Irritable Bowel Syndrome, run by University Hospital, Rouen at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 17 Dec 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: The Medical Device (SmartPill) used in this project is no longer on the market). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Correlation between efficacy of the low FODMAP diet on severity and the colonic pH (time frame: 6 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Dec 2024.