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CompletedNCT05618106Updated Apr 2, 2025

Low FODMAP Diet in Patients With IBS

An interventional study of Low FODMAP DIET = Diet with Low polyol, FOS and GOS in Irritable Bowel Syndrome, sponsored by Jens Rikardt Andersen. Completed at 1 site in Denmark. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-04-02.

Sponsored by Jens Rikardt Andersen · Not applicable, Interventional, and Treatment

From the registry’s dates

  • Registered 3 years 8 months after the study started (first participant enrolled Mar 2019, registered Nov 2022).
Phase
Not applicable
Study type
Interventional
Enrollment
9
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • Irritable Bowel Syndrome

Keywords

  • Carbohydrates
  • low FODMAP diet
  • components in the low FODMAP diet
03

In context

Irritable Bowel Syndrome

1,116 studies on the registry are indexed under Irritable Bowel Syndrome; 208 are open to participants now.

This study's enrollment of 9 is below the median of 70 across 896 interventional studies indexed under Irritable Bowel Syndrome.

Browse Irritable Bowel Syndrome studies →

Lead sponsor

Jens Rikardt Andersen is the lead sponsor of 24 studies on the registry; 1 is open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

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

Exclusion criteria

Exclusion Criteria:

  • Dementia
  • lack of ability to speak Danish
  • additional chronic diseases prevailing participation
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Crossover assignment
Masking
None (open label)
Enrollment
9 participants (actual)

Study arms

  • Experimental
    low FODMAP diet

    Diet low in all kinds of FODMAPS

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

  • Placebo comparator
    Low Fodmap diet but polyols allowed

    Diet low in FOS and GOS

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

  • Active comparator
    Low Fodmap diet but FOS and GOS allowed

    Diet low in polyols

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

Interventions

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

    Low Polyol diet

06

What researchers measure

Primary outcomes

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

    Score in points (low score means few symptoms)

    Time frame: 3 months

Secondary outcomes

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

    Score in points (high score means better life satisfaction)

    Time frame: 3 months

07

Study locations

1 site
  • University of Copenhagen
    Copenhagen, Frederiksberg 1958, Denmark
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Apr 2, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT05618106
Lead sponsor
Jens Rikardt Andersen
Responsible party
Jens Rikardt Andersen (Assoc Prof, University of Copenhagen) — Sponsor-investigator
First posted
Nov 16, 2022
Start date
Mar 1, 2019
Primary completion
Oct 1, 2019
Completion
Feb 1, 2020
Last update
Apr 2, 2025

Study contacts

Jens R Andersen, MD, MPA
study chair · University of Copenhagen

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Mar 2025. You cannot join it, but the record below documents what was studied.

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