Non-coeliac wheat sensitivity wheat sensitivity
Conditions
Interventions
Participants will be recruited into one of two studies. As part of each study,
participants will undergo three intervention days (separated by a wash-out
period) in a cross-over design, according to
Sponsors
Universiteit Maastricht
Eligibility
Age
18 Years to 64 Years
Inclusion criteria
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
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The main study parameter is the change in overall intestinal symptom score, measured by a 100mm visual analogue scale (VAS), induced by the bread type consumed. | — |
Secondary
| Measure | Time frame |
|---|---|
| - Individual gastro-intestinal and extra-intestinal symptoms - Average stool frequency and consistency - Gut microbiota composition and activity | — |
Countries
Netherlands
Outcome results
None listed