Low FODMAP Diet in Patients With IBS

Irritable Bowel Syndrome Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05618106
• Other study ID #: FODMAP
• Status: Completed
• Phase: N/A
• Start date: March 1, 2019
• Est. completion date: February 1, 2020

Study information

• Verified date: January 2024
• Source: University of Copenhagen
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 9
• Est. completion date: February 1, 2020
• Est. primary completion date: October 1, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Irritable Bowel Syndrome
• Syndrome

Intervention

Other:
• variations of the low FODMAP diet
Cross-over of 3 interventions in IBS patients: Low Polyol diet Low FOS+GOS diet Low FODMAP diet

Locations

Country	Name	City	State
Denmark	University of Copenhagen	Copenhagen	Frederiksberg

Sponsors (1)

Lead Sponsor	Collaborator
Jens Rikardt Andersen

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Birmingham IBS questionnaire and adequate relief (IBS-AR).	Score in points (low score means few symptoms)	3 months
Secondary	IBS Quality of Life Scale questionnaire (IBS-QOL)	Score in points (high score means better life satisfaction)	3 months