NCT05779358: WoW

Gluten and (Extra-)Intestinal Symptoms in NCGS

Completed NA Last updated 22 March 2023

What this trial tests

NA trial testing Expectancy and gluten in Non-celiac Gluten Sensitivity in 84 participants. Completed in 15 February 2022.

Timeline

19 October 2018

Primary endpoint
31 January 2022

15 February 2022

Quick facts

Lead sponsor	Maastricht University
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	triple
Primary purpose	basic science
Enrollment	84
Start date	19 October 2018
Primary completion	31 January 2022
Estimated completion	15 February 2022
Sites	3 locations across United Kingdom, Netherlands

Drugs / interventions tested

• Expectancy and gluten

Conditions studied

• Non-celiac Gluten Sensitivity — all drugs for Non-celiac Gluten Sensitivity →

Sponsor

Maastricht University

Who can join

Adults 18 to 70, any sex, with Non-celiac Gluten Sensitivity. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

The goal of this randomized, double-blind, placebo-controlled study is to investigate the effect of expectancy related to gluten consumption versus actual gluten intake on overall GI symptoms in individuals with non-coeliac gluten sensitivity (NCGS)

The main questions it aims to answer are:

* what is the effect of consumer expectancy, related to either gluten-containing or gluten-free oat bread, on short-term (within 8 hours) overall GI symptoms in individuals with NCGS?
* what is the effect of actual gluten intake on short-term (within 8 hours) overall GI symptoms in individuals with NCGS

Participants will be randomised into four groups:

1. Participants with the expectation of receiving gluten-containing bread and actually receiving gluten-containing oat bread during the test day. (E+ G+)
2. Participants with the expectation of receiving gluten-containing bread, but actually receiving gluten-free oat bread during the test day. (E+ G-)
3. Participants with the expectation of receiving gluten-free bread but actually receiving gluten-containing oat bread during the test day. (E- G+)
4. Participants with the expectation of receiving gluten-free bread and actually receiving gluten-free oat bread during the test day. (E- G-)

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

1. The effect of expectancy versus actual gluten intake on gastrointestinal and extra-intestinal symptoms in non-coeliac gluten sensitivity: a randomised, double-blind, placebo-controlled, international, multicentre study.
   de Graaf MCG, Lawton CL, Croden F, Smolinska A, et al · · 2024 · cited 36× · PMID 38040019 · DOI 10.1016/s2468-1253(23)00317-5