Low FODMAP Diet in Patients With IBS

NCT ID: NCT05618106

Last Updated: 2025-04-02

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 9 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-03-01
• Study Completion Date: 2020-02-01

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.

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.

Conditions

Irritable Bowel Syndrome

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

low FODMAP diet

Diet low in all kinds of FODMAPS

Group Type: EXPERIMENTAL

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

Intervention Type: OTHER

Low Polyol diet

Low Fodmap diet but polyols allowed

Diet low in FOS and GOS

Group Type: PLACEBO_COMPARATOR

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

Intervention Type: OTHER

Low Polyol diet

Low Fodmap diet but FOS and GOS allowed

Diet low in polyols

Group Type: ACTIVE_COMPARATOR

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

Intervention Type: OTHER

Low Polyol diet

Interventions

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

Low Polyol diet

Intervention Type: OTHER

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Jens Rikardt Andersen

OTHER

Sponsor Role: lead

Responsible Party

Jens Rikardt Andersen

Assoc Prof

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

Jens R Andersen, MD, MPA

Role: STUDY_CHAIR

University of Copenhagen

Locations

University of Copenhagen

Copenhagen, Frederiksberg, Denmark

Countries

Denmark

Other Identifiers

FODMAP

Identifier Type: -

Identifier Source: org_study_id