Effect of FODMAP Restriction on Persistent GI-symptoms in Coeliac Patients
Key facts
- Who runs it
- Oslo University Hospital
- Where
- Norway1 site in 1 countryChoose a country to see its sites
- Trial code
- Status
- Completed
- People taking part
- 80 people enrolled
- Started
- 1 Oct 2018
- Ended
- 28 Jul 2025
- Type of study
- Interventional, 2 groupsOne group gets an existing treatment, for comparison.
- Treatments tested
- Low FODMAP diet
- Record updated
- 17 April 2026
Who can take part
- Age
- 18 years to 75 years
- Sex
- Women and men
- Healthy volunteers
- Cannot take part
The registry criteria, word for word
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Who can take part
- Coeliac disease
- Adherent to GFD for at least 12 months
- Strictly adherent to GFD
- Normal coeliac disease (CD) serology and duodenal biopsy (Marsh 0-1)
- Persistent GI-symptoms defined by GSRS-IBS score of 30 or more
- Living less than 2 hour from study centre
Who cannot take part
- Use of immunomodulating drugs in the last 3 months
- Use of anti-inflammatory drugs in the last 3 months
- Use of antacid drugs in the last 2 months
- Previous tried the LFD with guidance of a dietician
- Ongoing infection (mild infection such as upper airway infection is ok)
- Other chronical bowel disorder (except for IBS)
- Pregnancy or lactating women
This trial has no sites in United States.
It has sites in one country. Choose a country to see its sites.
About the trial
What the trial wants to find out
The first aim of the study is to investigate the prevalence of persistent gastrointestinal symptoms and compliance with gluten-free diet and the intake of FODMAP in adult celiac patients.
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A web-based survey wil be performed and thereafter a randomized controlled trial to test the effect of a FODMAP reduction in patients with celiac disease with irritable bowel-like symptoms.
The 2 groups in the trial
- Low FODMAP diet (LFD)Existing treatment, for comparison
The LFD wil receive advice on how to follow a low FODMAP diet. They wil follow this diet for 4 weeks. Thereafter they receive advice on how to reintroduce high FODMAPs again.
Treatment: Low FODMAP diet
- ControlNo study treatment, for comparison
Control group. Participants follow their regular gluten-free diet (GFD), with no changes to their diet. They wil receive the same dietary advice as the LFD-group after the 4-week study.
Data and sources
- Registry record
- Listed on ClinicalTrials.gov.
- Official title
- Effect of Fermentable Oligo-, di-, and Monosaccharides and Polyols (FODMAP) Restriction on Persistent GI-symptoms in Coeliac Patients
- Record updated
- 17 April 2026