The Celiac Disease Center at Columbia University is currently
seeking volunteers to participate in a clinical trial.
This clinical trial will study the effectiveness of a new drug that may help patients with celiac disease. In this study we are determining whether this drug allows people to heal the intestinal damage faster than the gluten-free diet alone.
To be eligible for this study you must meet the following inclusion
criteria:
-Men and women between the ages of 18- 75 inclusive
-Recent biopsy proven diagnose of celiac disease( 4-6 weeks)
-Gluten free diet for less than 6 weeks or not on the gluten free as yet.
-Willing to complete 5 study visits in a period of 12 weeks
-You cannot have any chronic GI disease other than Celiac Disease
-You cannot have diabetes
-You cannot chronically consume non-steroidal anti-inflammatory agents (NSAIDS) such as Advil or Aleve or take drugs like Nexium,Maalox or pancreatic enzyme replacement.
-Willingness to use an approved form of birth control (if required)
You must remain on your gluten-free diet for the duration of the study. You will be randomized (as in the flip of a coin) to either the study drug or drug placebo (sugar pill). You will have a
physical exam by the study doctor.
-You will have an upper GI endoscopy to obtain duodenal/jejunal biopsies. Blood and urine will be collected from you at each visit. You will be asked to fast and collect your overnight urine before each study visit. You will also answer gastrointestinal and health questionnaires that will be given to you while you participate in the study.
If interested, please contact the research coordinator Maria Teresa Minaya @ 212-305-5422 mtm2111@columbia.edu.
