Drug Study in Patients with Celiac Disease

The University of Chicago and Dr. Semrad are conducting a study to see whether an new experimental drug could induce remission in patients with active Celiac Disease or protect patients who eat gluten from ill effects. Celiac Disease is an inherited disease where the intestinal lining is inflamed in response to the ingestion of a protein known as gluten. Gluten is present in many grains including rye, oats, barley and triticale. An experimental drug is a drug that has not been approved by the U.S. Food and Drug Administration (FDA) to treat this medical condition.

We are seeking volunteers who have biopsy-proven Celiac Disease and have been on a gluten-free diet for at least six months to participate in this study. If you meet the conditions required to participate in this study and decide to participate, you will be randomly (like the flip of a coin) be assigned to one of four “arms” of the study. Three arms will take the active drug with gluten and one arm will include a drug placebo (a sugar pill that doesn’t contain any active drug) drugs in this study. You must remain on your gluten-free diet for the duration of the study.

The study is approximately 10 weeks long and involves seven visits to the University of Chicago DCAM. As part of this study, you will have a physical exam by the study doctor. Blood and urine will be collected at each visit. You will be asked to fast and collect your overnight urine before each study visit. You will also answer weekly gastrointestinal and health questionnaires in an electronic (computer) diary that will be given to you while in the study.

There may be no benefit to you for participating in this study. During the course of this study, the drug you are receiving may or may not be effective in treating your Celiac Disease.

If you are interested in learning more about this new drug and perhaps have an interest in participating in this study, please contact me or the study coordinator,

Participation Details

Initial selection criteria include:

• Must be at least 18 years of age
• Must not be pregnant or breast feeding during the study
• Must be available for clinic visits for the duration of the study
• Must meet study medical criteria as evaluated by Dr. Semrad

Study Director: Dr. Carol Semrad
Department: Gastroenterology

For more information contact:
Kimberly Neven, RN
kneven@medicine.bsd.uchicago.edu
(773) 834-2875.

IRB: #15687A