Back to resultsThe Effect of a Low FODMAP Diet in Irritable Bowel Syndrome Patients (FIBS)
Primary Purpose
Irritable Bowel Syndrome, FODMAP
Status
Unknown status
Phase
Not Applicable
Locations
Belgium
Study Type
Interventional
Intervention
low FODMAP diet
Sponsored by
About this trial
This is an interventional treatment trial for Irritable Bowel Syndrome
Eligibility Criteria
Inclusion Criteria:
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
Exclusion Criteria:
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.
Sites / Locations
- KU LeuvenRecruiting
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
low FODMAP diet
Arm Description
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
Full Information
NCT ID
NCT04373304
First Posted
April 29, 2020
Last Updated
May 6, 2020
Sponsor
Universitaire Ziekenhuizen KU Leuven
1. Study Identification
Unique Protocol Identification Number
NCT04373304
Brief Title
The Effect of a Low FODMAP Diet in Irritable Bowel Syndrome Patients
Acronym
FIBS
Official Title
The Effect of a Low FODMAP Diet in Irritable Bowel Syndrome Patients
Study Type
Interventional
2. Study Status
Record Verification Date
May 2020
Overall Recruitment Status
Unknown status
Study Start Date
November 25, 2019 (Actual)
Primary Completion Date
July 1, 2021 (Anticipated)
Study Completion Date
July 1, 2021 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Universitaire Ziekenhuizen KU Leuven
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief 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. 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Irritable Bowel Syndrome, FODMAP
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Masking Description
Patients are blinded during reintroduction.
Allocation
N/A
Enrollment
45 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
low FODMAP diet
Arm Type
Experimental
Intervention Type
Other
Intervention Name(s)
low FODMAP diet
Intervention Description
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.
Primary Outcome Measure Information:
Title
Irritable Bowel Syndrome Symptom Severity Scale (IBS-SSS)
Description
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.
Time Frame
approximately 2 years
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
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
Exclusion Criteria:
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Jan Tack, professor
Phone
016344225
Email
jan.tack@kuleuven.be
Facility Information:
Facility Name
KU Leuven
City
Leuven
State/Province
Vlaams-Brabant
ZIP/Postal Code
3000
Country
Belgium
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jan Tack, professor
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
The Effect of a Low FODMAP Diet in Irritable Bowel Syndrome Patients
We'll reach out to this number within 24 hrs