Celiac Disease Research

Critical Research Areas

Dr. Fasano’s Discoveries Lead to Alba Therapeutics Beginning Clinical Trials

As many of you already know, Alba Therapeutics has successfully completed a Phase I clinical trial for celiac disease and Phase II has already begun. This multicenter, double blind, placebo controlled dose ranging study will evaluate the safety, tolerability and efficacy of AT-100 (a zonulin receptor antagonist) in 79 celiac disease subjects during gluten challenge. The CFCR continues our close partnership with Alba Therapeutics and so far we are able to capitalize on the resources from the donations to keep providing crucial information to optimize the effort of the ongoing clinical trial.

Cloning the Zonulin Gene

What is Zonulin?

Zonulin regulates the permeability of the intestines by controlling the opening and closing of specialized structures that act like gates between cells. When the body produces too much zonulin, these gates get stuck open for too long and allow undigested foodstuff, toxins and other bacterial and viral particles access to the immune system.

Why is Cloning Important?

Cloning a gene means isolating an exact copy of a single gene from the entire genome of an organism. This involves copying the DNA sequence of that gene into a smaller more accessible piece of DNA. This makes it easier to study the function of the individual gene in the laboratory. As a result of the cloning, large amounts of zonulin can be produced to study its functions.

Natural History of Celiac Disease

The CFCR has been working on a major project that we would like to push forward- A better understanding of the natural history of undiagnosed celiac disease in the US.

Gluten Threshold Research Study

This study in conjunction with the University of Ancona (Italy) was aimed at establishing the maximal amount of gluten tolerated by celiac patients. Our preliminary data shows that 10 mg of gluten is safe. We have finalized the study and this will be published soon in the American Journal of Clinical Nutrition.

Potential Animal Model for CD

Celiac disease could provide a unique opportunity to tackle the pathogenic basis of the autoimmune processes. However, the lack of an animal model for the disease represents a major limitation in reaching that goal. The CFCR has been working with a pedigreed colony of baboons with heredity chronic diarrhea to determine if they could be used as a possible non-human primate model for CD. Preliminary data suggests that the baboons could potentially be used as a primate non-human model of CD.

Current Research Studies

INFANT NUTRITION AND RISK OF CELIAC DISEASE: PROPOSAL FOR AN INTERVENTION, PROSPECTIVE, MULTICENTER STUDY

The Center is working to develop a major intervention study in neonates aimed at establishing whether the timing of gluten introduction in the diet of infants, genetically at risk for celiac disease, may affect the chance to develop the disease. To enroll in this study, or for more information, please email glutenproject@peds.umaryland.edu.

Research Goals

• Implement the diagnostic tools necessary to possibly eliminate the intestinal biopsy for confirmation of CD.
• Find an alternative treatment/cure for Celiac Disease.
• Clone the Zonulin gene.
• Further investigate the genetics of CD.
• Continue advocating for increased awareness of CD among health care professionals, government agencies, and industry.
• Examine the psychological impact of CD on the newly diagnosed patient and his/her family.
• Continue our working relationship with Congress on the Food Allergen Labeling & Consumer Protection Act and collaborate with the Food and Drug Administration (FDA) in implementing the labeling law.

To receive updates on our research, please submit your name and address to Pam King, Director of Operations.

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