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 @ 5:23 PM
Ignite Modification Date:
2025-12-24 @ 5:23 PM
NCT ID:
NCT05103150
Eligibility Criteria:
Inclusion Criteria:
* Patients naïve to GFD;
* With clinical history suggestive of malabsorption (weight loss, chronic diarrhea, iron-deficiency, anemia, etc.);
* And serologic suspicion of CD as positive or borderline antiendomysial (normal values are absent for both IgA and IgG) and antitransglutaminase antibodies (normal values 0-10 U/mL).
Exclusion Criteria:
* Presence of severe gastrointestinal or systemic disease (e.g., chronic pancreatitis, liver cirrhosis, and blood coagulation disorders) impacts cardiovascular risk assessment.
* Presence of duodenal ulcer in the context of patients with upper gastrointestinal bleeding.
* History of any type of duodenal surgery.
* Pregnancy or nursing female.
* Refusal to participate in this observational trial.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
79 Years
Study:
NCT05103150
Study Brief:
Protocol Section:
NCT05103150