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:
2025-12-25 @ 1:34 AM
Ignite Modification Date:
2025-12-25 @ 1:34 AM
NCT ID:
NCT03731494
Eligibility Criteria:
Inclusion Criteria:
* history of SNAS (coexistence of typical cutaneous and gastrointestinal symptoms),
* positive Ni-patch test,
* clinical improvement at least 70% from baseline after 4 weeks on a low-Ni diet,
* positivity of a double blind placebo-controlled oral Ni challenge (DBPCO),
* written informed consent.
Exclusion Criteria:
* age \< 18 years and \> 65 years,
* other organic gastrointestinal diseases, such as peptic ulcer, inflammatory bowel diseases, celiac disease, gastrointestinal infections, and small intestinal bacterial overgrowth,
* diabetes mellitus,
* hepatic, renal or cardiac dysfunction,
* thyroid disease or tumor,
* concomitant treatment with steroids and/or antihistamines in the previous 4 weeks, pregnancy, lactation,
* smoking, abuse of alcohol, coffee, tea, and cola intake,
* refusal to participate.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
65 Years
Study:
NCT03731494
Study Brief:
Protocol Section:
NCT03731494