Comparison of how different wheat breads are tolerated by individuals with suspected wheat sensitivity
Assessing the Tolerability of Different Types of Wheat Breads in Patients With Suspected Wheat Sensitivity
This study is testing how well different types of wheat bread are tolerated by people who might have a sensitivity to wheat.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 64 (estimated) |
| Ages | 18 Years to 75 Years |
| Sex | All |
| Sponsor | University of Hohenheim Academic / other |
| Locations | 2 sites (Stuttgart, Baden-Wurttemberg and 1 other locations) |
| Trial ID | NCT06152445 on ClinicalTrials.gov |
What this trial studies
This study investigates the tolerability of various types of wheat bread in individuals who may have non-celiac wheat sensitivity (NCWS). It employs a double-blind placebo-controlled food challenge and confocal laser endomicroscopy (CLE) to assess the intestinal mucosal response to different bread types. The goal is to improve the understanding and diagnosis of NCWS, which is often misdiagnosed due to inconsistent criteria. Participants will adhere to a prescribed diet while their gastrointestinal symptoms are monitored over the study period.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 to 75 with chronic gastrointestinal symptoms and a history of wheat sensitivity.
Not a fit: Patients with diagnosed celiac disease or wheat allergy will not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to better diagnostic methods and dietary recommendations for individuals suffering from wheat sensitivity.
How similar studies have performed: While studies on gluten and wheat sensitivity exist, this specific approach using CLE and various bread types is relatively novel.
Eligibility criteria
Show full inclusion / exclusion criteria
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
Where this trial is running
Stuttgart, Baden-Wurttemberg and 1 other locations
- Institute of Nutritional Medicine, University of Hohenheim — Stuttgart, Baden-Wurttemberg, Germany (Recruiting)
- Institute of Nutritional Medicine, University Hospital Schleswig Holstein, Campus Lübeck — Lübeck, Schleswig-Holstein, Germany (Recruiting)
Study contacts
- Study coordinator: Stephan C Bischoff, Prof.Dr
- Email: bischoff.stephan@uni-hohenheim.de
- Phone: 071145924101
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.