The Effect of Gluten in Patients With Irritable Bowel Syndrome and Healthy Volunteers — PROT-IBS  

Irritable Bowel Syndrome Clinical Trial

Official title: The Effect of Gluten in Patients With Irritable Bowel Syndrome and Healthy Volunteers: a Randomized, Placebo-controlled Double-blind Cross-over Trial

Status Completed

Clinical Trial Summary

Patients with Irritable Bowel Syndrome (IBS) often link their symptoms to foods. Interest in dietary management recently increased, including the use of a gluten-free diet.

To investigate relation of gluten-free diet (GFD) and IBS, a randomized, double-blind, placebo-controlled cross-over trial will be carried out in adults (>18) and patients with IBS according to Rome IV criteria. The aim is to assess gluten-free versus gluten-containing diet in IBS patients and Healthy Volunteers.

Clinical Trial Description

The study is a randomized, double-blind, placebo-controlled, cross-over trial.

The aim is to assess the effects of gluten-free diet (GFD) compared to gluten-containing diet (GCD) in IBS patients and Healthy Volunteers on gastrointestinal symptoms, visceral sensitivity, bacterial fermentation, psychological factors and quality of life. The primary hypothesis is that GFD decreases gastrointestinal symptoms compared to GCD and that this change is accompanied with reduced visceral sensitivity and change in bacterial fermentation. The secondary hypothesis is that GFD positively influences psychological factors and quality of life.

IBS patients (Rome IV) and Healthy Volunteers are challenged with gluten in this randomized, double-blind, placebo-controlled, cross-over study. They start with GFD or GCD and cross over to the other intervention (both for 14 days). In between there is a wash-out period of at least 14 days. The subjects will get gluten-free meals (lunch and dinner) and have to sprinkle powder over the meals, concealed in sachets with either gluten (vital gluten) or placebo (rice starch). The subjects will follow a strict GFD during the GFD and GCD periods. The subjects will eat and drink as before the study during the washout period.

Primary outcomes are change in gastrointestinal symptoms, assessed by questionnaires, including IBS Severity Scoring System (IBS-SSS) and Gastrointestinal Symtom Rating Scale-IBS (GSRS-IBS). A 50-point reduction in IBS-SSS indicates clinical response. Bacterial fermentation (exhaled hydrogen and methane) and visceral sensitivity will be measured using the Lactulose-Nutrient Challenge Test. Secondary outcomes are change in psychological factors and quality of life assessed by questionnaires, including CSI, HADS, HSPS, IBSQOL, PHQ-15 and VSI. ;

Related Conditions & MeSH terms

• Irritable Bowel Syndrome
• Syndrome

• NCT number: NCT03869359
• Study type: Interventional
• Source: Sahlgrenska University Hospital, Sweden
• Status: Completed
• Phase: N/A
• Start date: October 1, 2018
• Completion date: October 1, 2019