Assessing the Tolerability of Different Types of Wheat Breads in Patients With Suspected Wheat Sensitivity

Status: Recruiting
Location: See all (2) locations...
Intervention Type: Other
Study Type: Interventional
Study Phase: Not Applicable
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
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 75
Healthy Volunteers: t
View:

• 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)

Locations
Other Locations
Germany
Institute of Nutritional Medicine, University Hospital Schleswig Holstein, Campus Lübeck
RECRUITING
Lübeck
Institute of Nutritional Medicine, University of Hohenheim
RECRUITING
Stuttgart
Contact Information
Primary
Stephan C Bischoff, Prof.Dr
bischoff.stephan@uni-hohenheim.de
071145924101
Backup
Patricia P Petersen, M.Sc
patricia.petersen@uni-hohenheim.de
071145923622
Time Frame
Start Date: 2023-04-19
Estimated Completion Date: 2024-06
Participants
Target number of participants: 64
Treatments
Placebo_comparator: Gluten free bread
Bread will be eaten by the participants for 7 consecutive days
Active_comparator: Gluten free bread with added wheat flour
Bread will be eaten by the participants for 7 consecutive days
Experimental: Wheat bread with Yeast, short fermentation + bread improver
Bread will be eaten by the participants for 7 consecutive days
Experimental: Wheat bread with Yeast, long fermentation
Bread will be eaten by the participants for 7 consecutive days
Experimental: Wheat bread with Sourdough, long fermentation
Bread will be eaten by the participants for 7 consecutive days
Related Therapeutic Areas
Sponsors
Collaborators: University Hospital Schleswig-Holstein
Leads: University of Hohenheim

This content was sourced from clinicaltrials.gov