Celiac Disease Study
Principal Investigator: Cristina Hill, MD
Sub-Investigators: Larry W. Schafer, MD; Julie M. Kittelsrud, CNP; Susan E. Weaver, CNP
Study Coordinator: Linda Randel King
Study Description: Phase IIB, Randomized, Double-Blind, Placebo-Controlled Study for the Treatment of Active Celiac Disease with AT-1001
Overview: The purpose of this clinical drug study is to examine how safe and effective the investigational medication is in treating individuals with Celiac Disease.
Participants in this research study will receive the following, at no cost: physical examinations, vital signs measurements, EKGs, laboratory evaluations, and study-related medication. Patients will receive either the investigational medication or a placebo (a “sugar pill” with no active medicine). There is a two-in-three chance of receiving the investigational medication.
Inclusion Criteria:
- Men and women, age 18 to 75
- Clinical diagnosis of Celiac Disease
- Compliance with a gluten-free diet for the duration of the study
Exclusion Criteria:
- Women who are pregnant, breastfeeding or planning to become pregnant
- Diagnosis of Refractory Celiac Disease or severe complications of Celiac Disease
- Diagnosis of any chronic active Gastrointestinal disease other than celiac disease
- Current smoker or user of nicotine-containing products
- History of alcohol or drug abuse in the past 2 years
Contact: Linda Randel King
Phone: (605) 322-3074
Email: linda.randelking@mckennan.org
