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Low FODMAP Diet in Patients With IBS

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05618106
Enrollment
9
Registered
2022-11-16
Start date
2019-03-01
Completion date
2020-02-01
Last updated
2025-04-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Irritable Bowel Syndrome

Keywords

Carbohydrates, low FODMAP diet, components in the low FODMAP diet

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.

Interventions

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

Low Polyol diet

Sponsors

Jens Rikardt Andersen
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
NONE

Intervention model description

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

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Birmingham IBS questionnaire and adequate relief (IBS-AR).3 monthsScore in points (low score means few symptoms)

Secondary

MeasureTime frameDescription
IBS Quality of Life Scale questionnaire (IBS-QOL)3 monthsScore in points (high score means better life satisfaction)

Countries

Denmark

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026