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Completed

NCT Number: NCT05618106

Low FODMAP Diet in Patients With IBS

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.

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Key information

Conditions

Irritable Bowel Syndrome Colonic Diseases Colonic Diseases, Functional Digestive System Diseases Gastrointestinal Diseases Intestinal Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Copenhagen

Copenhagen, Frederiksberg, 1958, Denmark

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Low FODMAP DIET = Diet with Low polyol, FOS and GOS

Other

Low Polyol diet

Primary outcomes

  1. Birmingham IBS questionnaire and adequate relief (IBS-AR).

    Time frame: 3 months

    Score in points (low score means few symptoms)

Secondary outcomes

  1. IBS Quality of Life Scale questionnaire (IBS-QOL)

    Time frame: 3 months

    Score in points (high score means better life satisfaction)

Sponsors and collaborators

Lead sponsor

Jens Rikardt Andersen

Other

Registry information

Official study title

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

Important dates

Study start
2019
Primary completion
2019
Study completion
2020
First posted
Nov 16, 2022
Registry last updated
Apr 2, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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