Status:
COMPLETED
Serum Markers in Gluten Challenge
Lead Sponsor:
Beth Israel Deaconess Medical Center
Collaborating Sponsors:
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Conditions:
Celiac Disease
Eligibility:
All Genders
17-72 years
Phase:
NA
Brief Summary
1. The purpose of this research study is to evaluate non-invasive markers of celiac disease activity in subjects that are on a gluten-free diet, in remission from celiac disease who undergo gluten cha...
Detailed Description
The diagnosis of celiac disease carries with it important ramifications. Celiac disease is a systemic immunologic disorder in which the sentinel lesion is an enteropathy triggered by polypeptides deri...
Eligibility Criteria
Inclusion
- Age between 17 and 72 years, inclusive.
- Subject must have been diagnosed with celiac disease by duodenal / jejunal biopsy at least 6 months prior to entrance into the study.
- Subject has Anti-Tissue Transglutaminase (anti-tTG) ≤ 20 EU as measured by serology.
- Subject must be on a gluten-free diet for at least the past 6 months.
- 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.
- Subject must sign an Institutional Review Board approved informed consent and agree to complete required clinic visits.
- BMI between 18.5 and 38, inclusive.
Exclusion
- Subject has Anti-Tissue Transglutaminase (anti-tTG) \> 20 EU as measured by serology.
- Subject has other food intolerances or food allergies (other than celiac disease) that would interfere with the conduct of the study).
- Subject has a history of severe acute symptomatic reactions to sporadic gluten ingestion
- Subject has any chronic active GI disease other than celiac disease (e.g. Crohn's disease, IBS).
- Subjects with symptomatic neurological or psychiatric disease(s) that would interfere with the conduct of the study.
- Subject has clinically significant abnormal laboratory test results at the screening visit or as determined by the Principal Investigator
- Subject is pregnant or breast feeding.
- Subject (premenopausal females) is sexually active without contraception.
- Subject should not have been on steroids in the past 3 months.
- Subject is deemed inappropriate by the Principal Investigator.
Key Trial Info
Start Date :
April 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 1 2011
Estimated Enrollment :
21 Patients enrolled
Trial Details
Trial ID
NCT00931892
Start Date
April 1 2009
End Date
August 1 2011
Last Update
June 4 2021
Active Locations (1)
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1
Beth Israel Deaconess Medical Center
Boston, Massachusetts, United States, 02215