Wheat Bread Study: Comparison of the Tolerance of Different Wheat Breads
Assessing the Tolerability of Different Types of Wheat Breads in Patients With Suspected Wheat Sensitivity
University of Hohenheim
64 participants
Apr 19, 2023
INTERVENTIONAL
Conditions
Summary
This study aims to assess the differences in tolerability of differently manufactured wheat breads in a target group of individuals with suspected wheat sensitivity. Additionally, it will be verified, if the absence of a response to oral exposure to defined bread types is associated with an absence of mucosal changes following CLE-assisted mucosal provocation with bread.
Eligibility
Inclusion Criteria8
- Age ≥18 ≤75 years
- Signed declaration of consent
- Willingness to adhere to the prescribed diet for the duration of the study
- Chronic gastrointestinal symptoms for at least 6 months
- Anamnestic wheat sensitivity
- No acute or chronic gastrointestinal diseases (e.g. celiac disease / wheat allergy)
- No or stable medication for at least 3 months
- No participation in another clinical trial (current or within the past 30 days)
Exclusion Criteria5
- Taking intestinal therapeutics, antibiotics, immunosuppressants, anti-allergic medication or similar
- Pregnancy / lactation
- Occurrence of relevant diseases (possibly individual decision)
- Revocation of consent
- Concurrent participation in another clinical study
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Interventions
Different wheat breads
Locations(2)
View Full Details on ClinicalTrials.gov
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NCT06152445