Clinical Trials Logo
  1. Home
  2. Non-celiac Gluten Sensitivity
  3. NCT05779358

Gluten and (Extra-)Intestinal Symptoms in NCGS — WoW  

Non-celiac Gluten Sensitivity Clinical Trial

Official title:
The Effects of Bread Consumption on Intestinal and Extra-intestinal Symptoms in Non-coeliac Gluten Sensitivity

Clinical Trial Summary

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-)

Clinical Trial Description

One on-site test, starting with baseline measurement (T = 0). Thereafter, subjects are told that they will receive two slices of gluten-containing bread (E+) or gluten-free bread (E-). Consequently, they receive breakfast with two slices of bread (gluten-containing (G+) or gluten-free (G-)). After breakfast, questionnaires will be completed every hour for 8 hours. After T = 4 hours, participants receive lunch with two slices of the same bread, combined with the same expectancy, that they received at breakfast. Follow-up measurements include the same questionnaires at the end of day 1 (from end of test day until they go to sleep), at the end of day 2 and at the end of day 3. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT05779358
Study type Interventional
Source Maastricht University
Contact
Status Completed
Phase N/A
Start date October 19, 2018
Completion date February 15, 2022
View Details
See also
  Status Clinical Trial Phase
Recruiting NCT05555446 - Bovine Colostrum to Prevent Absorption of Gluten Early Phase 1
Completed NCT02472704 - Lymphocytic Enteritis and Suspected Coeliac Disease: Gluten vs Placebo N/A
Completed NCT03775499 - Probiotic BL NCC 2705 and Gluten Sensitivity N/A
Recruiting NCT05238545 - The Effect of Gluten-free Diet on Parkinsonism N/A
Recruiting NCT06152445 - Wheat Bread Study: Comparison of the Tolerance of Different Wheat Breads N/A
Completed NCT04401956 - Bread Study: Comparison of the Tolerance of Spelt and Wheat Bread N/A
Recruiting NCT06338891 - Can Gluten/Wheat or Other Foods be Responsible for FMF Attacks
Recruiting NCT05644795 - Wheat-free Diet in the Treatment of Sjogren's Syndrome N/A
Completed NCT04377061 - Anemia in Non-celiac Wheat Sensitivity
Completed NCT04077840 - Autoimmune Diseases and Serum Autoantibodies in NCWS and IBS Patients
Completed NCT04769180 - Extraintestinal Non Celiac Wheat Sensitivity
Not yet recruiting NCT06191432 - Tolerability of an Ancient Grain in Patients With Non-Celiac Wheat Sensitivity N/A
Completed NCT04017585 - Identification of Gluten Sensitivity in Irritable Bowel Syndrome N/A
Recruiting NCT02810301 - Efficacy of Probiotic ES1 for the Treatment of Non-Celiac Gluten Sensitivity Phase 2