Serum Markers in Gluten Challenge

Completed · Not applicable

Conditions studied: Celiac Disease

In brief

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 challenge. 2. The secondary aims of this protocol are to identify novel mediators important in the pathophysiology of celiac disease and to evaluate changes in metabolism with gluten exposure.

Key facts

Study ID: NCT00931892
Run by: Beth Israel Deaconess Medical Center
People needed: 21
Starts: 2009-04-01
Expected to finish: 2011-08-01
Last updated by the study team: 2021-06-04

Who can join

Age: 17 and older, up to 72. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

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.

You may not qualify if…

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.

Where it is running

Beth Israel Deaconess Medical Center — Boston, Massachusetts, United States

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.