The effects of the different bread types of fully known composition on gastrointestinal symptoms in individuals with non-coeliac wheat sensitivity.

Completed

• Conditions: Non-coeliac wheat sensitivity; wheat sensitivity; 10017947

• Registration Number: NL-OMON52898
• Lead Sponsor: niversiteit Maastricht

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 15 April 2024

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 44

Inclusion Criteria

Study A and B
- Develops self-reported GI symptoms within 12 hours after a single intake of
bread;
- Aged between 18-70 years;
- Asymptomatic or mildly symptomatic (overall symptoms score with VAS below or
equal to 30 mm) while on their symptom-free diet;
- Must have a freezer (-18ºC) to store the study breads during the study.

Follow-up measurement
- (1) NCWS subject: develops GI symptoms within 12 hours after consumption of
at least one of the study breads of study A or B (+15 mm on VAS); OR (2)
Healthy control (sex matched to NCWS subjects): eats bread regularly (min. 5
days per week)
- Age between 18-70 years;
- Must have a fridge (4-7ºC) to shortly store the collected faecal sample.

Exclusion Criteria

Study A and B
- Medical history of coeliac disease, wheat allergy, presence of an organic
gastrointestinal (GI) disease (such as inflammatory bowel disease) or other
disease which may interfere with NCWS symptoms (upon judgment of the
physician-clinical investigator (prof. Keszthelyi, Gastroenterologist MUMC+/
prof. Witteman, PI and consulting gastroenterologist WUR));
- Previous major abdominal surgery or radiotherapy interfering with
gastrointestinal function;
- Use of medication potentially influencing gastrointestinal function and/or
NCWS symptoms is allowed, provided that dosing has been stable for * 1 month
before enrolment;
- Administration of probiotic, prebiotic supplements, investigational drugs or
participation in any scientific intervention study, which may interfere with
this study (to be decided by the principle investigator), in the 14 days prior
to the study.

Follow-up measurement - in addition to the criteria listed above:
- Use of antibiotics during the 6 past months prior to faecal sampling;
- Healthy controls: developing GI symptoms after consumption of bread, or
following a gluten-free or wheat-free diet.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>The main study parameter is the change in overall intestinal symptom score,<br /><br>measured by a 100mm visual analogue scale (VAS), induced by the bread type<br /><br>consumed. </p><br>

Secondary Outcome Measures

Name	Time	Method
<p>- Individual gastro-intestinal and extra-intestinal symptoms<br /><br>- Average stool frequency and consistency<br /><br>- Gut microbiota composition and activity</p><br>