RecruitingNot Applicable

Wheat Bread Study: Comparison of the Tolerance of Different Wheat Breads

Germany64 participantsStarted 2023-04-19

Plain-language 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.

Who can participate

Age range18 Years – 75 Years

SexALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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

What they're measuring

Change of IBS-SSS Total Score

Timeframe: Study examinations are at baseline, after wash-out phases (week 1, 3, 5) and after bread intervention phases (week 2, 4, 6).

Trial details

NCT IDNCT06152445

SponsorUniversity of Hohenheim

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2024-06

Contact for this trial

Stephan C Bischoff, Prof.Dr

071145924101 bischoff.stephan@uni-hohenheim.de

View on ClinicalTrials.gov More Non-celiac Gluten Sensitivity trials