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 @ 10:41 PM
Ignite Modification Date:
2025-12-24 @ 10:41 PM
NCT ID:
NCT02750735
Eligibility Criteria:
Inclusion Criteria:
All the patients met the recently proposed criteria:
* negative serum anti-tissue transglutaminase and antiendomysium (EmA) IgA and IgG antibodies;
* absence of intestinal villous atrophy;
* IgE-mediated immunoallergy tests negative to wheat (skin prick tests and/or serum specific IgE detection).
Adjunctive criteria adopted in our patients were:
* resolution of the gastrointestinal symptoms on a standard elimination diet, without wheat, cow's milk, egg, tomato, chocolate, or other food(s) causing self-reported symptoms;
* symptom reappearance on double-blind placebo-controlled (DBPC) wheat challenge, performed as described previously. As in previous studies, DBPC cow's milk protein challenge and other "open" food challenges were also performed.
Exclusion Criteria:
Exclusion criteria were:
* age \< 18 years;
* positive EmA in the culture medium of the duodenal biopsies, even if the villi to crypts ratio in the duodenal mucosa was normal;
* self-exclusion of wheat from the diet and refusal to reintroduce it before entering the study;
* other organic cutaneous and/or gastrointestinal diseases;
* concomitant treatment with steroids and/or antihistamines.
Allergic contact dermatitis was diagnosed in patients showing local eczematous lesions on the skin in close contact with nickel-containing objects. Suspected systemic nickel allergy syndrome (SNAS), was defined as a reaction characterized not only by diffused eczematous lesions (systemic contact dermatitis) but also by extracutaneous signs and symptoms, mainly gastrointestinal, after ingestion of nickel-rich foods (i.e. tomato, cocoa, beans, mushrooms, vegetables, wheat flour, etc). In all cases, the diagnosis was confirmed by means of the epicutaneous patch tests which provoked delayed lesions.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT02750735
Study Brief:
Protocol Section:
NCT02750735