Dr. Jeffrey Aron and his associates at the Center for Inflammatory Bowel Diseases at California Pacific Medical Center have been approved as the only site west of the Mississippi to conduct research studies of AT-1001, a molecule designed by Alba Therapeutics. This molecule is being studied in human trials to see if it is effective in preventing intestinal leakage (leaky gut) and improve symptoms, along with a gluten free diet, in patients with Celiac Disease.
How will this study be conducted?
People who volunteer for the study will be randomized into one of three groups: those who take a placebo, those who take 24 mg of AT-1001 per day, or those who take 48 mg of AT-1001 per day. This is a double-blind study, meaning that neither the volunteer patients nor the researchers evaluating the effects know which patients are in which group.
All patients will follow a gluten-free diet, and measurements of intestinal leakage will be done at the beginning, twice during treatment, and at the end of the study. A second biopsy will also be taken at the end of the study. In addition, a standardized questionnaire will be given to measure clinical response (report of symptoms). Safety follow-up visits and labs will also be done.
Study visits, counseling for the gluten-free diet, labs and biopsies are all paid for by the research project.
Who is eligible for this study?
You may be eligible for the study if:
- you are newly diagnosed, with positive anti-Tissue Transglutaminase (anti-tTG) antibodies and a biopsy that is Marsh grade II or more. (If the biopsy was taken at another hospital, it needs to be recent and will be reviewed to ensure it meets the study parameters. If Dr. Aron performs the biopsy it will be covered by the research project.)
- you are a diagnosed Celiac who hasn’t adhered to a gluten-free diet or has not gotten better on a gluten-free diet, and meet the requirements above.
- you are a family member of someone with celiac and you suspect that you may have celiac also. If you show symptoms of celiac disease and are interested in becoming a volunteer, your celiac testing may be covered by the research project.
How does someone volunteer for the study?
Please contact Robin Bishop, Dr. Aron’s Research Coordinator, for more details.