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

Status Active, not recruiting

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.

Clinical Trial 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. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT03678935
Study type	Interventional
Source	Oslo University Hospital
Contact
Status	Active, not recruiting
Phase	N/A
Start date	October 1, 2018
Completion date	December 31, 2025

View Details

See also
Status	Clinical Trial	Phase
Completed	`NCT03720314` - Microbiota Profiling in IBS
Recruiting	`NCT06166563` - Exercise, Irritable Bowel Syndrome and Fibromyalgia	N/A
Completed	`NCT05213910` - Study of a Management Strategy of Functional Bowel Disordes Related to Irritable Bowel Syndrome (IBS) With a Mixture of 8 Microbiotic Strains	N/A
Recruiting	`NCT05985018` - Traditional Dietary Advice Vs. Mediterranean Diet in IBS	N/A
Completed	`NCT04486469` - Efficacy of Physiotherapy Techniques on Irritable Bowel Syndrome (IBS). Pilot Study.	N/A
Completed	`NCT06407609` - Positive Outcomes of the Supplementation With Lecithin-based Delivery Form of Curcuma Longa and of Boswellia Serrata in IBS	N/A
Completed	`NCT04656730` - Effect of STW5 (Iberogast ®) and STW5-II (Iberogast N®) on Transit and Tolerance of Intestinal Gas	Phase 4
Completed	`NCT04145856` - Combination of Alverine-simeticone and i3.1 Probiotic in IBS-D and IBS-M in Mexico	Phase 4
Recruiting	`NCT04138225` - The Ecological Role of Yeasts in the Human Gut
Active, not recruiting	`NCT03586622` - One Year Home Monitoring and Treatment of IBS Patients	N/A
Completed	`NCT05207618` - Utility of the Administration of Chesnut and Quebracho Extract for Irritable Bowel Syndrome Diarrhea Predominant	N/A
Not yet recruiting	`NCT06369753` - Visible Abdominal Distension	N/A
Not yet recruiting	`NCT05157867` - In Vivo Effects of Amylase Trypsin Inhibitors	N/A
Not yet recruiting	`NCT05100719` - The Role of Irritable Bowel Syndrome in Lactose Intolerance (LION)	N/A
Recruiting	`NCT05001997` - Effects of Lactose-free Dairy Products on Athletes With Irritable Bowel Syndrome	N/A
Recruiting	`NCT02953171` - Probiotics in the Treatment of Irritable Bowel Syndrome	N/A
Completed	`NCT02977975` - Lacto-fermented Sauerkraut in the Treatment of Irritable Bowel Syndrome	N/A
Completed	`NCT03266068` - Epidemiology and Pathophysiology of Post-Infectious Functional GI Disorders
Completed	`NCT03318614` - Bifidobacterium Infantis M-63 Improves Mental Health in Irritable Bowel Syndrome Developed After a Major Flood Disaster	Phase 2/Phase 3
Completed	`NCT02980406` - The Role of FODMAPs in Upper GI Effects, Colonic Motor Activity and Gut-brain Signaling at the Behavioral Level	N/A