Irritable Bowel SyndromeFIBSNCT04373304
The Effect of a Low FODMAP Diet in Irritable Bowel Syndrome Patients
A study testing low FODMAP diet in people with Irritable Bowel Syndrome and FODMAP, run by Universitaire Ziekenhuizen KU Leuven at 1 site in Belgium.
Trial summary
Tertiary care IBS patients will be recruited for a prospective low FODMAP intervention study, hereby focusing on the reintroduction phase of the diet, where patients are blindly challenged with different FODMAP groups administered as powder, to be added to the strict FODMAP exclusion phase. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Irritable Bowel Syndrome, FODMAP
- What is being tested?
- low FODMAP diet
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 45 participants
- Where
- 1 siteBelgium
- Study dates
- 25 Nov 2019to 1 Jul 2021
- 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 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients are eligible for the study if all of the following criteria are met:
- 1. Patients with irritable bowel syndrome as per Rome IV diagnostic criteria
- Symptom characteristics of IBS according to Rome IV criteria 2. Patients must provide witnessed written informed consent prior to any study procedures being performed 3. Patients aged between 18 and 70 years inclusive 4. Male or female patients
Who cannot join
- Patients are excluded from the study if any of the following criteria are met:
- Patients with any condition which, in the opinion of the investigator, makes the patient unsuitable for entry into the study
- Patients with any major psychiatric disorders (including those with a major psychosomatic element to their gastrointestinal disease), depression, alcohol or substance abuse in the last 2 years
- Patients presenting with predominant symptoms of functional dyspepsia (FD) and of gastro-oesophageal reflux disease (GERD)
- Patients who changed their diet over the last 3 months or have previously tried the low FODMAP diet are excluded from the study.
- Females who are pregnant or lactating are excluded from the study.
Trial locations and contacts
1 site in 1 country.
Belgium1 site, 1 recruiting
- Recruiting
KU Leuven
Leuven, Vlaams-Brabant, 3000
Jan Tack, professor
About this study
Tertiary care IBS patients will be recruited for a prospective low FODMAP intervention study, hereby focusing on the reintroduction phase of the diet, where patients are blindly challenged with different FODMAP groups administered as powder, to be added to the strict FODMAP exclusion phase. During the screening phase of two weeks, baseline data regarding psychological, nutritional, microbial, and genetics will be collected. Predictors of treatment response (a 50-point drop on the IBS-severity scoring system (IBS-SSS) during the strict FODMAP exclusion phase of 6 weeks) will be studied with linear mixed models.
- Conditions
- Irritable Bowel Syndrome, FODMAP
- Being tested
- low FODMAP diet
- 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 dietOther
A diet specifically developed for the management of IBS is the low Fermentable Oligosaccharides, Disaccharides, Monosaccharides, And Polyols (FODMAP) diet. FODMAP is a collective term that includes fructose in excess of glucose, oligosaccharides including fructans/fructo-oligosaccharides (FOS), galacto-oligosaccharides, sugar polyols such as sorbitol and mannitol, and lactose. Controlled studies have established efficacy of the low FODMAP in managing IBS symptoms, but this diet is complex, associated with low calorie intake, and requires individualized explanation and follow-up by an experienced dietician.
| Study group | Role | What they receive |
|---|---|---|
| low FODMAP diet | Experimental | Not described Receives: Other: low FODMAP diet |
What is being measured
The primary outcome is the main question the study is designed to answer.
Irritable Bowel Syndrome Symptom Severity Scale (IBS-SSS)
The primary endpoint is the variable used to assess the main objective, the efficacy of low FODMAP diet on gastrointestinal symptoms in IBS (focusing on the reintroduction phase). The variables used will be the symptom scores of several symptom questionnaires. Ultimately, the efficacy of the diet is based on improvement of symptom scores. Improvement is defined as a 50-point drop on the Irritable Bowel Syndrome Symptom Severity Scale (IBS-SSS). In this questionnaire, each quesiton is scored from 0-100, with a maximum total score of 500. Patients reporting scores <50 are defined as non-IBS individuals, a score from 50-175 indicated mild disease, 175-300 moderate and >300 severe.
Measured: approximately 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 May 2020
- Study start25 Nov 2019
- Primary completion1 Jul 2021 (estimated)
- Study completion1 Jul 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Irritable Bowel SyndromeStudies of the same condition, open and under way.
- More trials run by Universitaire Ziekenhuizen KU LeuvenThe 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
- 45 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Universitaire Ziekenhuizen KU Leuven
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Prof Dr Jan Tack, Universitaire Ziekenhuizen KU Leuven
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04373304
- Sponsor's protocol ID
- s63269
- Acronym
- FIBS
- Status last verified
- May 2020
- First submitted
- 29 Apr 2020
- Last updated
- 8 May 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Van den Houte K, Colomier E, Routhiaux K, Marien Z, Schol J, Van den Bergh J, Vanderstappen J, Pauwels N, Joos A, Arts J, Caenepeel P, De Clerck F, Matthys C, Meulemans A, Jones M, Vanuytsel T, Carbone F, Tack J. Efficacy and Findings of a Blinded Randomized Reintroduction Phase for the Low FODMAP Diet in Irritable Bowel Syndrome. Gastroenterology. 2024 Jul;167(2):333-342. doi: 10.1053/j.gastro.2024.02.008. Epub 2024 Feb 23.
PubMed 38401741
Study at a glance
From the registry record, last updated by the sponsor on 8 May 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of a Low FODMAP Diet in Irritable Bowel Syndrome Patients
- ClinicalTrials.gov ID
- NCT04373304
- Acronym / sponsor ID
- FIBS / s63269
- Conditions
- Irritable Bowel Syndrome, FODMAP
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 45 participants (estimated)
- Lead sponsor
- Universitaire Ziekenhuizen KU LeuvenUniversity, hospital or other
- Study start
- 25 Nov 2019 (actual)
- Primary completion
- 1 Jul 2021 (estimated)
- Study completion
- 1 Jul 2021 (estimated)
- First posted
- 4 May 2020 (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.
Tertiary care IBS patients will be recruited for a prospective low FODMAP intervention study, hereby focusing on the reintroduction phase of the diet, where patients are blindly challenged with different FODMAP groups administered as powder, to be added to the strict FODMAP exclusion phase. During the screening phase of two weeks, baseline data regarding psychological, nutritional, microbial, and genetics will be collected. Predictors of treatment response (a 50-point drop on the IBS-severity scoring system (IBS-SSS) during the strict FODMAP exclusion phase of 6 weeks) will be studied with linear mixed models.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| low FODMAP diet | Experimental | Other: low FODMAP diet |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Patients are eligible for the study if all of the following criteria are met:
- 1. Patients with irritable bowel syndrome as per Rome IV diagnostic criteria
- Symptom characteristics of IBS according to Rome IV criteria 2. Patients must provide witnessed written informed consent prior to any study procedures being performed 3. Patients aged between 18 and 70 years inclusive 4. Male or female patients
Key exclusion criteria (6 listed)
- Patients are excluded from the study if any of the following criteria are met:
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 dietA diet specifically developed for the management of IBS is the low Fermentable Oligosaccharides, Disaccharides, Monosaccharides, And Polyols (FODMAP) diet. FODMAP is a collective term that includes fructose in excess of glucose, oligosaccharides including fructans/fructo-oligosaccharides (FOS), galacto-oligosaccharides, sugar polyols such as sorbitol and mannitol, and lactose. Controlled studies have established efficacy of the low FODMAP in managing IBS symptoms, but this diet is complex, associated with low calorie intake, and requires individualized explanation and follow-up by an experienced dietician. | Other | low FODMAP diet |
Primary outcome
Irritable Bowel Syndrome Symptom Severity Scale (IBS-SSS)
Time frame: approximately 2 years
The primary endpoint is the variable used to assess the main objective, the efficacy of low FODMAP diet on gastrointestinal symptoms in IBS (focusing on the reintroduction phase). The variables used will be the symptom scores of several symptom questionnaires. Ultimately, the efficacy of the diet is based on improvement of symptom scores. Improvement is defined as a 50-point drop on the Irritable Bowel Syndrome Symptom Severity Scale (IBS-SSS). In this questionnaire, each quesiton is scored from 0-100, with a maximum total score of 500. Patients reporting scores <50 are defined as non-IBS individuals, a score from 50-175 indicated mild disease, 175-300 moderate and >300 severe.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 May 2020.
- Derived from this study: PubMed 38401741Van den Houte K, Colomier E, Routhiaux K, Marien Z, Schol J, Van den Bergh J, Vanderstappen J, Pauwels N, Joos A, Arts J, Caenepeel P, De Clerck F, Matthys C, Meulemans A, Jones M, Vanuytsel T, Carbone F, Tack J. Efficacy and Findings of a Blinded Randomized Reintroduction Phase for the Low FODMAP Diet in Irritable Bowel Syndrome. Gastroenterology. 2024 Jul;167(2):333-342. doi: 10.1053/j.gastro.2024.02.008. Epub 2024 Feb 23.
- Individual participant dataSharing planned: No
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.
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 and FODMAP, run by Universitaire Ziekenhuizen KU Leuven at 1 site in Belgium.
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 3 inclusion and 6 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: status not confirmed, as of the sponsor's last update on 8 May 2020. 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 Belgium. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Jan Tack, professor (016344225, jan.tack@kuleuven.be), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Irritable Bowel Syndrome Symptom Severity Scale (IBS-SSS) (time frame: approximately 2 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04373304, which also lists 1 linked publication.
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 8 May 2020.