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:
2025-12-26 @ 11:49 AM
Ignite Modification Date:
2025-12-26 @ 11:49 AM
NCT ID:
NCT02805816
Eligibility Criteria:
Inclusion Criteria:
1. Child with clinical suspicion of CD (chronic or recurrent diarrhea, Failure to thrive, growth impairment , iron deficiency anemia, vomiting, chronic abdominal pain, abdominal distension , constipation, fatigue, recurrent oral aphthous or dermatitis herpetiformis) and high TG2 serology (\>2 times upper limit of normal) who is referred to gastroscopy and intestinal biopsies Or
2. Asymptomatic child who belongs to high risk group of celiac (Diabetes mellitus type 1, Hashimoto thyroiditis, Down syndrome, Turner syndrome, Williams syndrome, Auto-immune Hepatitis or first degree with CD) and high TG2 serology (\>2 times upper limit of normal) who is referred to gastroscopy and intestinal biopsies .
and
3. signed consent form
Exclusion Criteria:
1. IgA (Immunoglobulin A) deficiency
2. Malignancy
3. Inflammatory Bowel Disease
4. Severe chronic infection (HIV, Tuberculosis)
5. Primary immunodeficiency
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
6 Months
Maximum Age:
18 Years
Study:
NCT02805816
Study Brief:
Protocol Section:
NCT02805816