Clinical trial NCT03678935: Effect of FODMAP Restriction on Persistent GI-symptoms in Coeliac Patients
Official title: Effect of Fermentable Oligo-, di-, and Monosaccharides and Polyols (FODMAP) Restriction on Persistent GI-symptoms in Coeliac Patients
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Celiac Disease
Irritable Bowel Syndrome
Diet Modification
Gluten Sensitivity
Keywords: Celiac disease
Irritable bowel syndrome
Lead sponsor: Oslo University Hospital
Sponsor class: OTHER
First posted: 2018-09-20
Enrollment: 80
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: The intervention group receives advice on following the low-FODMAP diet, and the control group follows their regular gluten free diet.
Primary purpose: TREATMENT

Brief 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.

Detailed description: 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.

Eligibility criteria: 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

Primary outcomes:
measure: Change in gastrointestinal symptoms
timeFrame: 4 weeks
Secondary outcomes:
measure: Changes in biomarkers like faecal microbiota
timeFrame: 4 weeks
measure: Quality of Life in patients with coeliac disease: Short form- 36 (SF-36)
timeFrame: 4 weeks
Other outcomes:
Locations:
city: Oslo
country: Norway
facility: Rikshospitalet-Radiumhospitalet HF, Oslo University Hospital
state: Postboks PB 4950 Nydalen
Study officials:
affiliation: Oslo University hospital and University of Oslo
name: Knut Lundin, Professor
role: PRINCIPAL_INVESTIGATOR
References:
citation: Herfindal AM, van Megen F, Gilde MKO, Valeur J, Rudi K, Skodje GI, Lundin KEA, Henriksen C, Bohn SK. Effects of a low FODMAP diet on gut microbiota in individuals with treated coeliac disease having persistent gastrointestinal symptoms - a randomised controlled trial. Br J Nutr. 2023 Dec 28;130(12):2061-2075. doi: 10.1017/S0007114523001253. Epub 2023 Jun 5.
citation: van Megen F, Skodje GI, Lergenmuller S, Zuhlke S, Aabakken L, Veierod MB, Henriksen C, Lundin KEA. A Low FODMAP Diet Reduces Symptoms in Treated Celiac Patients With Ongoing Symptoms-A Randomized Controlled Trial. Clin Gastroenterol Hepatol. 2022 Oct;20(10):2258-2266.e3. doi: 10.1016/j.cgh.2022.01.011. Epub 2022 Jan 17.
citation: van Megen F, Fossli M, Skodje GI, Carlsen MH, Andersen LF, Veierod MB, Lundin KEA, Henriksen C. Nutritional assessment of women with celiac disease compared to the general population. Clin Nutr ESPEN. 2023 Apr;54:251-257. doi: 10.1016/j.clnesp.2023.01.031. Epub 2023 Feb 2.
citation: Skodje GI, van Megen F, Stendahl M, Henriksen C, Lundin KEA, Veierod MB. Detection of gluten immunogenic peptides and the Celiac Disease Adherence Test to monitor gluten-free diet: a pilot study. Eur J Clin Nutr. 2022 Jun;76(6):902-903. doi: 10.1038/s41430-021-01054-6. Epub 2022 Jan 10.
citation: van Megen F, Skodje GI, Stendahl M, Veierod MB, Lundin KEA, Henriksen C. High disease burden in treated celiac patients - a web-based survey. Scand J Gastroenterol. 2021 Aug;56(8):882-888. doi: 10.1080/00365521.2021.1930146. Epub 2021 May 30.