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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

80 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-10-01

Study Completion Date

2025-07-28

Brief Summary

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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.

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Detailed Description

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Effect of FODMAP reduction in patients with celiac disease. Celiac disease is an immune-mediated disease that causes damage to the intestines. The condition affects 1-2% of the population, and the incidence is increasing. Treatment with gluten-free diet usually produces good results, yet there are many patients who have persistent gastrointestinal symptoms. Studies indicate that this applies to as many as 20%, but the situation in Norway in unknown. Nor is it known why somebody has persistent gastro- intestinal complaints. It may be due to difficulty following the diet or what is called irritable bowel syndrome (IBS), which is a fairly common condition in the population.

It has been shown that people with IBS can benefit from a diet with reduced FODMAP content. The term FODMAP is an acronym for: Fermentable Oligo, Di-, Monosaccharides and Polyols. It is a type of carbohydrate that is not absorbed in the large intestine, but continues to the colon where they are fermented by the bacteria. Example of foods with a high content of FODMAP is wheat, onion, garlic, parsley, apples, pears, mango, beans, honey and milk. It is not known whether celiac patients with persistent symptoms will have the beneficial effect of low FODMAP diet.

In this study, investigators want to study the prevalence of persistent gastrointestinal symptoms and compliance with gluten-free diet and the intake of FODMAP in adult celiac patients. Members of the Norwegian coeliac organization will be invited to participate in the study. A web-based questionnaire is used to make it easy for members to respond.

Participants who report persistent gastrointestinal intestinal symptoms will then be invited to a randomized and controlled study. They will be divided into two groups where one group will be advised to reduce the intake of FODMAP and the other group will be advised to follow a strict gluten-free diet. Participants will record stomach and intestinal complaints before and after four weeks with study sites. Investigators will find out whether there is a difference between gastric and intestinal complaints between the two groups. Blood- and feces samples will also be collected.

The results will provide new knowledge about how to adapt dietary advice to celiac patients with persistent gastrointestinal complaints, and hopefully help them to a better quality of life.

Conditions

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Celiac Disease Irritable Bowel Syndrome Diet Modification Gluten Sensitivity

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

The intervention group receives advice on following the low-FODMAP diet, and the control group follows their regular gluten free diet.

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Low FODMAP diet (LFD)

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.

Group Type ACTIVE_COMPARATOR

Low FODMAP diet

Intervention Type OTHER

The intervention group follows the low FODMAP diet for 4 weeks.

Control

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.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Low FODMAP diet

The intervention group follows the low FODMAP diet for 4 weeks.

Intervention Type OTHER

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No