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 @ 6:50 PM
Ignite Modification Date:
2025-12-24 @ 6:50 PM
NCT ID:
NCT05782257
Eligibility Criteria:
Inclusion Criteria:
* Diagnosis of CeD based on specific CeD serology (elevated anti-tissue transglutaminase IgA, deaminated gliadin peptides-Immunoglobulin G or anti-endomysial antibodies IgA) and confirmed by duodenal biopsies showing villous atrophy (Marsh 3a or greater);
* Adopting a gluten-free diet for at least 6 months;
* Untreated Zn deficiency (Zn plasma levels ≤9.3 µmol/L)
Exclusion Criteria:
* Are already on a Zn optimized diet;
* Treatment with Zn supplements or multivitamins containing \>11 mg of Zn in the last month;
* Prior allergic reaction to Zn supplements;
* Treatment with antibiotics or probiotics supplements in the last 30 days;
* Pregnancy or lactation
* Current infection in the last 30 days;
* Intestinal obstruction, short gut (remnant bowel \<180 cm), or any serious illness considered by the investigator that will interfere with the study procedure or results. Data including medication and supplementation will be recorded in case report form and Zn content added to total Zn in the analysis.
* Untreated pancreatic insufficiency (fecal elastase \<200).
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT05782257
Study Brief:
Protocol Section:
NCT05782257