CompletedNot Applicable

Gluten and (Extra-)Intestinal Symptoms in NCGS

Netherlands, United Kingdom84 participantsStarted 2018-10-19

Plain-language 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-)

Who can participate

Age range18 Years – 70 Years

SexALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * Develops self-reported GI symptoms within 8 hours after a single intake of gluten-containing products, without a diagnosis of an organic GI disease; * Following of willing to follow a gluten-free or gluten-restricting diet (based on a gluten-free dietary compliance questionnaire of Biagi et al. (only group 2, 3 and 4 will be eligible), for at least 1 week prior to study participation and willing to continue with this throughout the study; * Asymptomatic or only mildly symptomatic (overall (GI) symptom score with VAS \< 30mm) while on the gluten-free diet; * Willing to participate in a study in which they have to consume 4 slices of gluten-containing or gluten-free bread for breakfast and lunch during the test day; * Willing and able to give written informed consent and to understand, participate and comply with the research project requirements. Exclusion Criteria: * Coeliac disease; * Wheat allergy; * Presence of an organic GI disease (such as inflammatory bowel disease) or other disease which may interfere with NCGS symptoms (upon judgment of the physician clinical investigator); * Previous major abdominal surgery or radiotherapy interfering with GI function: * Uncomplicated appendectomy, cholecystectomy and hysterectomy allowed unless within the past 6 months; * Other surgery may be allowed based upon judgment of the physician-clinical investigator; * Use of medication potentially influencing GI function and/or NCGS symptoms is allowed, provid…

What they're measuring

Overall gastrointestinal symptom score (short term)

Timeframe: Test day: baseline (T = 0 hours), hourly after breakfast (T = 1 hour until T = 4 hours), and hourly after lunch (T = 5 hours until T = 8 hours)

Trial details

NCT IDNCT05779358

SponsorMaastricht University

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2022-01-31