RECRUITINGINTERVENTIONAL
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
About This Trial
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.
Who May Be Eligible (Plain English)
Who May Qualify:
- 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)
Who Should NOT Join This Trial:
- 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
Always talk to your doctor about whether this trial is right for you.
Original Eligibility Criteria
View original clinical language
Inclusion Criteria:
* 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 Criteria:
* 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
Treatments Being Tested
OTHER
Wheat bread
Different wheat breads
Locations (2)
Institute of Nutritional Medicine, University of Hohenheim
Stuttgart, Baden-Wurttemberg, Germany
Institute of Nutritional Medicine, University Hospital Schleswig Holstein, Campus Lübeck
Lübeck, Schleswig-Holstein, Germany