MassGeneral Hospital for Children’s Center for Celiac Research Launches New Clinical Trial to Investigate Factors in Autoimmune Development

April 22, 2014

MassGeneral Hospital for Children’s Center for Celiac Research Launches New Clinical Trial to Investigate Factors in Autoimmune Development


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Looking for clues to celiac disease in infant study

Boston, MA– To unlock the mystery of how celiac disease and other autoimmune disorders develop, the Center for Celiac Research at MassGeneral Hospital forChildren (MGHfC) is enlisting the help of the youngest research participants. Enrollment is now under way for an international, observational study of approximately 500 infants through the Center’s clinical research study called “CDGEMM,” which stands for Celiac Disease, Genomic, Environmental, Microbiome and Metabolomic Study.

Infants with a first-degree relative (mother, father or sibling) with celiac disease are currently being recruited through clinical centers in Italy and the United States. Researchers will study different factors involved in the development of celiac disease, an autoimmune disorder in which eating gluten – a protein found in products that contain wheat, rye or barley – sets off a reaction that damages the small intestine.

Environmental factors such as method of birth delivery, use of antibiotics, breast or formula feeding, and timing of food introduction early in the infant’s life will be examined. Another factor in the long-term study is the genetic makeup of the infants, specifically whether the infants have inherited genes involved in the expression of celiac disease.

“Celiac disease is a very complex disorder that can affect many different systems in the body,” says Alessio Fasano, MD, director of the Center for Celiac Research and division chief of the Division of Pediatric Gastroenterology and Nutrition at MGHfC, the principal investigator of the study. “Along with environmental and genetic factors, we think that the microbial colonies these babies have in their gut are very significant in the pathogenesis of celiac disease and possibly other autoimmune disorders.”

The five-year prospective study follows a pilot study of 47 infants investigating the timing of gluten introduction into the diet and the characteristic changes in the microbiota – the 100 trillion microorganisms in the gut – during the introduction of solid food. Fasano’s team looked at the role of the microbiota in the switch from tolerance to autoimmune response leading to the onset of celiac disease. Findings from the 2011 study suggested that understanding how the microbiota of infants with a genetic predisposition to celiac disease differ from those of infants without the predisposition might allow prediction of celiac disease or another autoimmunity disorder.

“When we realized that we might be able to pinpoint a biomarker that predicts which one of these infants might develop celiac disease or type 1 diabetes, it was not such a far leap to see that this could possibly play a role in the prevention of autoimmune disorders,” says Fasano. “By expanding the study, we’ll be able to take a really in-depth look – both in terms of the magnitude of the microbiota and the length of our study – to examine the genomic, environmental and metabolomic factors that precede the onset of celiac disease.”

The Center’s latest clinical trial is part of the broad research and clinical studies that are an integral component of MGHfC. “Dr. Fasano’s infant microbiome study fits in perfectly with our expanding clinical study portfolio that includes exciting breakthroughs in genetics and genomics,” says Ronald Kleinman, MD, physician in chief of MGHfC. “What makes this study so exciting is not only the treatment potential for celiac disease, but also the possibility of learning how we might prevent its onset.”

For more information about CDGEMM, please visit or

Massachusetts General Hospital, founded in 1811, is the original and largest teaching hospital of Harvard Medical School. The MGH conducts the largest hospital-based research program in the United States, with an annual research budget of more than $775 million and major research centers in AIDS, cardiovascular research, cancer, computational and integrative biology, cutaneous biology, human genetics, medical imaging, neurodegenerative disorders, regenerative medicine, reproductive biology, systems biology, transplantation biology and photomedicine.

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