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

Irritable Bowel Syndrome Clinical Trial

Official title:

Effect of Fermentable Oligo-, di-, and Monosaccharides and Polyols (FODMAP) Restriction on Persistent GI-symptoms in Coeliac Patients

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT03678935
• Other study ID #: 2018/1055
• Status: Active, not recruiting
• Phase: N/A
• Start date: October 1, 2018
• Est. completion date: December 31, 2025

Study information

• Verified date: October 2023
• Source: Oslo University Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 80
• Est. completion date: December 31, 2025
• Est. primary completion date: December 31, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Celiac Disease
• Diet Modification
• Gluten Sensitivity
• Irritable Bowel Syndrome

Intervention

Other:
• Low FODMAP diet
The intervention group follows the low FODMAP diet for 4 weeks.

Locations

Country	Name	City	State
Norway	Rikshospitalet-Radiumhospitalet HF, Oslo University Hospital	Oslo	Postboks PB 4950 Nydalen

Sponsors (1)

Lead Sponsor	Collaborator
Oslo University Hospital

Country where clinical trial is conducted

Norway, 

References & Publications (5)

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 Jun 5:1-15. doi: 10.1017/S0007114523001253. Online ahead of print. — View 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/s4143 — View 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 — View 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(1 — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in gastrointestinal symptoms	Measured by score in gastrointestinal symptom rating scale for irritable bowel syndrome (GSRS-IBS). The scoring is based on a 7-grade Likert scale in which 1 point indicates no symptoms and 7 points the most severe gastrointestinal symptoms. The total score in the gastrointestinal symptom rating scale for irritable bowel syndrome is calculated as a mean value of all 13 items. The maximum score is 91 and the minimum score is 13. A higher score means more severe symptoms. A score higher than 1 standard deviation (SD, 0.66 points) compared to the control mean are considered to have increased gastrointestinal symptoms.	4 weeks
Secondary	Changes in biomarkers like faecal microbiota	Altered faecal microbiota diversity, measured as a change in diversity and/or abundance or strains from baseline and after 4 weeks on a low FODMAP diet.	4 weeks
Secondary	Quality of Life in patients with coeliac disease: Short form- 36 (SF-36)	Changes in short form-36 (SF-36) as a measure of quality of life. SF-36 covers four physical health perceptions (physical functioning, role limitations because of physical health problems, bodily pain, and general health) and four mental health concepts (vitality, social functioning, role limitations because of personal or emotional problems, and mental health perceptions). Each scale is directly transformed into a 0-100 scale on the assumption that each question carries equal weight. The range of score is 0 to 100, where a higher score means better quality of life and the lower the score the more disability. A total score for mental health and physical health is calculated as an average of the subscales, with a range from 0 to 100. Here also the higher the score the better quality of life. The standardized combined scores in several populations have a mean of 50 and standard deviation 10. The scoring wil be performed as in the SF-36 scoring manual.	4 weeks