Status:
RECRUITING
Wheat Bread Study: Comparison of the Tolerance of Different Wheat Breads
Lead Sponsor:
University of Hohenheim
Collaborating Sponsors:
University Hospital Schleswig-Holstein
Conditions:
Non-celiac Gluten Sensitivity
Wheat Hypersensitivity
Eligibility:
All Genders
18-75 years
Phase:
NA
Brief 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,...
Detailed Description
Nowadays, more than 20% of people in industrialized countries suffer from a food intolerance or food allergy, with wheat and gluten intolerances on the rise. Besides the well-known conditions celiac d...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
April 19 2023
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
June 1 2024
Estimated Enrollment :
64 Patients enrolled
Trial Details
Trial ID
NCT06152445
Start Date
April 19 2023
End Date
June 1 2024
Last Update
May 17 2024
Active Locations (2)
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1
Institute of Nutritional Medicine, University of Hohenheim
Stuttgart, Baden-Wurttemberg, Germany, 70599
2
Institute of Nutritional Medicine, University Hospital Schleswig Holstein, Campus Lübeck
Lübeck, Schleswig-Holstein, Germany, 23562