Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 11:38 PM
Ignite Modification Date:
2025-12-24 @ 11:38 PM
NCT ID:
NCT04401956
Eligibility Criteria:
Inclusion Criteria:
* Age ≥18 ≤70 years
* Signed declaration of consent
* Willingness to adhere to the prescribed diet for the duration of the study
* Subjective bread wheat intolerance
* No known spelled intolerance
* No acute or chronic gastrointestinal diseases (e.g. celiac disease / wheat allergy)
* No participation in another clinical trial (current or within the past 30 days)
* Gluten-containing diet at least 6 weeks before the start of the study
Exclusion Criteria:
* Taking intestinal therapeutics, antibiotics, immunosuppressants or similar
* Pregnancy / lactation
* Relevant violations of the nutritional protocol
* Occurrence of relevant diseases (possibly individual decision)
* Revocation of consent
* Accommodation in a clinic or similar facility based on an official or judicial order
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
70 Years
Study:
NCT04401956
Study Brief:
Protocol Section:
NCT04401956