Actively Recruiting
Wheat Bread Study: Comparison of the Tolerance of Different Wheat Breads
Led by University of Hohenheim · Updated on 2024-05-17
64
Participants Needed
2
Research Sites
58 weeks
Total Duration
On this page
Sponsors
U
University of Hohenheim
Lead Sponsor
U
University Hospital Schleswig-Holstein
Collaborating Sponsor
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Wheat Bread Study: Comparison of the Tolerance of Different Wheat Breads
Who Can Participate
Eligibility Criteria
You may qualify if you...
- 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)
You will not qualify if you...
- 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
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 2 locations
1
Institute of Nutritional Medicine, University of Hohenheim
Stuttgart, Baden-Wurttemberg, Germany, 70599
Actively Recruiting
2
Institute of Nutritional Medicine, University Hospital Schleswig Holstein, Campus Lübeck
Lübeck, Schleswig-Holstein, Germany, 23562
Actively Recruiting
Research Team
S
Stephan C Bischoff, Prof.Dr
CONTACT
P
Patricia P Petersen, M.Sc
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
SINGLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
SUPPORTIVE_CARE
Number of Arms
5
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