Protocol for Correlating Enteropathic Severity and Small Intestinal CYP3A4 Activity in Patients With Celiac Disease
Status:
Completed
Trial end date:
2011-09-01
Target enrollment:
Participant gender:
Summary
The small bowel biopsy is the cornerstone of for the diagnosis of celiac disease. In addition
to being the gold standard for the initial diagnosis of celiac disease, periodic biopsies are
also recommended on an ongoing basis for this life-long disease. However, biopsy evaluation
is invasive and expensive. Therefore, there is a need for simple, non-invasive tests that can
be performed on celiac patients with subclinical disease.
The present study is based on the hypothesis that the expression and activity of cytochrome
P450 CYP3A4 in the small intestinal mucosa is a sensitive measure of enteropathy. Therefore
small intestinal CYP3A4 activity will be markedly different in celiac disease patients with
active disease as compared to patients in remission. Small intestinal CYP3A4 activity will be
measured in three ways:
(i) Cmax of oral simvastatin, a widely used drug that is predominantly metabolized by small
intestinal CYP3A4; (ii) AUC of oral simvastatin; and (iii) Measurement of CYP3A4 activity in
two small bowel biopsies.
Phase:
Phase 2/Phase 3
Details
Lead Sponsor:
All India Institute of Medical Sciences, New Delhi