Status:
COMPLETED
Effects of Different Bread Types in NCWS
Lead Sponsor:
Maastricht University
Collaborating Sponsors:
Wageningen University
Conditions:
Non-Coeliac Wheat Sensitivity (NCWS)
Eligibility:
All Genders
18-70 years
Phase:
NA
Brief Summary
Although wheat and gluten containing food products are generally considered to be healthy, a large number of individuals in the general population reduces or limits their intake and/or replaces wheat ...
Eligibility Criteria
Inclusion
- Develops of self-reported GI symptoms within 12 hours after a single intake of bread;
- Age between 18-70 years;
- Asymptomatic or only mildly symptomatic (overall) GI symptoms score with VAS \< 30mm) while on the gluten-free/gluten-restricted diet;
- Must have a freezer (-18ºC) to store the study breads during the study;
- Willing and able to give written informed consent and to understand, participate and comply with the research project requirements.
Exclusion
- Medical history of coeliac disease, wheat allergy, inflammatory bowel disease, 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 (Dr. Keszthelyi, Gastroenterologist MUMC+));
- Previous major abdominal surgery or radiotherapy interfering with gastrointestinal 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 (Dr. Keszthelyi, Gastroenterologist MUMC+), who will decide on inor exclusion based upon the surgery applied;
- 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;
- Excessive use of alcohol (\>15 alcoholic units per week), or other drugs;
- Plan to lose weight or follow a specific weight loss diet within the study period;
- Current malignancy;
- Pregnancy or breastfeeding;
- Participation in any scientific intervention study, which may interfere with this study;
- Insufficient fluency of the Dutch language.
- Follow-up measurement - inclusion criteria
- (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.
- Follow-up measurement - exclusion criteria 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
Key Trial Info
Start Date :
September 17 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 20 2022
Estimated Enrollment :
40 Patients enrolled
Trial Details
Trial ID
NCT04084470
Start Date
September 17 2019
End Date
December 20 2022
Last Update
March 28 2023
Active Locations (2)
Enter a location and click search to find clinical trials sorted by distance.
1
Maastricht University
Maastricht, Netherlands
2
Wageningen University
Wageningen, Netherlands