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 @ 3:24 PM
Ignite Modification Date:
2025-12-24 @ 3:24 PM
NCT ID:
NCT00931892
Eligibility Criteria:
Inclusion Criteria:
1. Age between 17 and 72 years, inclusive.
2. Subject must have been diagnosed with celiac disease by duodenal / jejunal biopsy at least 6 months prior to entrance into the study.
3. Subject has Anti-Tissue Transglutaminase (anti-tTG) ≤ 20 EU as measured by serology.
4. Subject must be on a gluten-free diet for at least the past 6 months.
5. Female subjects should be either post-menopausal (amenorrhea for at least 24 consecutive months), surgically sterile, or women of child-bearing potential (WOCP) with a negative urine beta human chorionic gonadotropin (HCG) pregnancy test prior to entering the study and who are using or agree to use acceptable methods of contraception. Abstinence is an acceptable means of avoiding pregnancy as long as the subject agrees to use contraception if they become sexually active. Acceptable contraceptives include intrauterine devices (IUDs), hormonal contraceptives (oral, depo, patch or injectable) in use for one month prior to screening and double barrier methods such as condoms or diaphragms with spermicidal gel or foam.
6. Subject must sign an Institutional Review Board approved informed consent and agree to complete required clinic visits.
7. BMI between 18.5 and 38, inclusive.
Exclusion Criteria:
1. Subject has Anti-Tissue Transglutaminase (anti-tTG) \> 20 EU as measured by serology.
2. Subject has other food intolerances or food allergies (other than celiac disease) that would interfere with the conduct of the study).
3. Subject has a history of severe acute symptomatic reactions to sporadic gluten ingestion
4. Subject has any chronic active GI disease other than celiac disease (e.g. Crohn's disease, IBS).
5. Subjects with symptomatic neurological or psychiatric disease(s) that would interfere with the conduct of the study.
6. Subject has clinically significant abnormal laboratory test results at the screening visit or as determined by the Principal Investigator
7. Subject is pregnant or breast feeding.
8. Subject (premenopausal females) is sexually active without contraception.
9. Subject should not have been on steroids in the past 3 months.
10. Subject is deemed inappropriate by the Principal Investigator.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
17 Years
Maximum Age:
72 Years
Study:
NCT00931892
Study Brief:
Protocol Section:
NCT00931892