CompletedNot Applicable

Effect of FODMAP Restriction on Persistent GI-symptoms in Coeliac Patients

Norway80 participantsStarted 2018-10-01

Plain-language summary

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. 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.

Who can participate

Age range

18 Years – 75 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * 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 Exclusion Criteria: * Pregnancy or lactating women * 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 * Ongoing infection (mild infection such as upper airway infection is ok) * Other chronical bowel disorder (except for IBS) * Previous tried the LFD with guidance of a dietician

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Change in gastrointestinal symptoms

Timeframe: 4 weeks

Trial details

NCT IDNCT03678935

SponsorOslo University Hospital

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2025-07-28

View on ClinicalTrials.gov More Celiac Disease trials