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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

Important: This information is not medical advice. Talk to your doctor about whether a clinical trial is right for you.

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