Low FODMAP Diet in Patients With IBS

March 27, 2025 updated by: Jens Rikardt Andersen

Modification of the Low FODMAP Diet in Treatment of Irritable Bowel Syndrome: A Randomised Cross-over Study

The aim was aimed to investigate if all carbohydrate groups eliminated in the Low FODMAP diet are equally important in relieving gastrointestinal symptoms in IBS.

in a randomized cross-over design to three different carbohydrate-modified diets: A) Low Polyol diet, B) Low FOS+GOS diet, and C) Low FODMAP diet for three months without wash-out-periods. Gastrointestinal symptoms, Quality of life was measured at baseline and after each intervention diet.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Low FODMAP diets contain 3 major types of carbohydrates to be avoided. The clasical diet is very difficult to maintain over longer periods of time. Therefore, we aimed to investigate if all carbohydrate groups in the Low FODMAP diet are equally important in relieving gastrointestinal symptoms in IBS.

Patients diagnosed with IBS according to the Rome III criteria were randomised in a cross-over design to three different carbohydrate-modified diets: A) Low Polyol diet, B) Low FOS+GOS diet, and C) Low FODMAP diet for a total of three months without wash-out-periods. Gastrointestinal symptoms were assessed by the Birmingham IBS questionnaire and adequate relief (IBS-AR). Quality of life was measured by the IBS Quality of Life Scale questionnaire (IBS-QOL). All registrations were performed at baseline and after each intervention diet.

Study Type

Interventional

Enrollment (Actual)

9

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Denmark
    • Frederiksberg
      • Copenhagen, Frederiksberg, Denmark, 1958
        • University of Copenhagen

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • IBS diagnosed by the Rome III criteria and
  • referred to the clinic for treatment by diet

Exclusion Criteria:

  • Dementia
  • lack of ability to speak Danish
  • additional chronic diseases prevailing participation

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: low FODMAP diet
Diet low in all kinds of FODMAPS
Other: Low FODMAP DIET = Diet with Low polyol, FOS and GOS
Low Polyol diet
Placebo Comparator: Low Fodmap diet but polyols allowed
Diet low in FOS and GOS
Other: Low FODMAP DIET = Diet with Low polyol, FOS and GOS
Low Polyol diet
Active Comparator: Low Fodmap diet but FOS and GOS allowed
Diet low in polyols
Other: Low FODMAP DIET = Diet with Low polyol, FOS and GOS
Low Polyol diet

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Birmingham IBS questionnaire and adequate relief (IBS-AR).
Time Frame: 3 months
Score in points (low score means few symptoms)
3 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
IBS Quality of Life Scale questionnaire (IBS-QOL)
Time Frame: 3 months
Score in points (high score means better life satisfaction)
3 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Jens Rikardt Andersen

Investigators

  • Study Chair: Jens R Andersen, MD, MPA, University of Copenhagen

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 1, 2019

Primary Completion (Actual)

October 1, 2019

Study Completion (Actual)

February 1, 2020

Study Registration Dates

First Submitted

November 8, 2022

First Submitted That Met QC Criteria

November 8, 2022

First Posted (Actual)

November 16, 2022

Study Record Updates

Last Update Posted (Actual)

April 2, 2025

Last Update Submitted That Met QC Criteria

March 27, 2025

Last Verified

March 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • FODMAP

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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