Low FODMAP Diet in Patients With IBS

NCT05618106 | Completed

• 1 other identifier: FODMAP
• Study Type: interventional
• Target: 9
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Irritable Bowel Syndrome

Keywords

Carbohydrates; low FODMAP diet; components in the low FODMAP diet

Outcome Measures

Primary Outcomes (1)

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

  Score in points (low score means few symptoms)

  3 months

Secondary Outcomes (1)

• IBS Quality of Life Scale questionnaire (IBS-QOL)

  3 months

Study Arms (3)

low FODMAP diet

EXPERIMENTAL

Diet low in all kinds of FODMAPS

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

Low Fodmap diet but polyols allowed

PLACEBO COMPARATOR

Diet low in FOS and GOS

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

Low Fodmap diet but FOS and GOS allowed

ACTIVE COMPARATOR

Diet low in polyols

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

Interventions

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

Low Polyol diet

Low Fodmap diet but FOS and GOS allowed; Low Fodmap diet but polyols allowed; low FODMAP diet

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Jens Rikardt Andersen: lead

Study Sites (1)

University of Copenhagen

Copenhagen, Frederiksberg, 1958, Denmark

Location

Related Publications (1)

• Jensen LG, Kjaer M, Andersen JR. Modification of the Low FODMAP Diet Is Feasible in the Treatment of Irritable Bowel Syndrome: A Randomised Crossover Study. Gastroenterol Res Pract. 2025 Nov 13;2025:4152978. doi: 10.1155/grp/4152978. eCollection 2025.

  PMID: 41278484 DERIVED

MeSH Terms

Conditions

Irritable Bowel Syndrome

Interventions

FODMAP Diet

Condition Hierarchy (Ancestors)

Colonic Diseases, Functional; Colonic Diseases; Intestinal Diseases; Gastrointestinal Diseases; Digestive System Diseases

Intervention Hierarchy (Ancestors)

Elimination Diets; Diet; Nutritional Physiological Phenomena; Diet, Food, and Nutrition; Physiological Phenomena

Study Officials

• Jens R Andersen, MD, MPA

  University of Copenhagen

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Assoc Prof

Model Details: Cross-over of 3 variations of the low FODMAP diet excluding 1 of the 3 components in every period

Study Record Dates

• First Submitted: November 8, 2022
• First Posted: November 16, 2022
• Study Start: March 1, 2019
• Primary Completion: October 1, 2019
• Study Completion: February 1, 2020
• Last Updated: April 2, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will not share

Locations

DK (1)