Wheat Bread Study: Comparison of the Tolerance of Different Wheat Breads (NCT06152445) | Clinical Trial Compass
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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 range
18 Years – 75 Years
Sex
ALL
See this in plain English?
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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
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).