Study into the causes of Crohn’s disease hits major milestone

After 10 years and a worldwide effort, Crohn’s and Colitis Canada is pleased to announce that the world-renowned Genetic, Environmental, Microbial (GEM) Project has reached its goal of 5,000 participants. Launched in 2008 at Mount Sinai Hospital in Toronto, the GEM Project is the world’s largest clinical study investigating the causes of Crohn’s disease. In this study of prospective development of Crohn’s, researchers are monitoring healthy individuals who have a sibling or parent with the disease and are tracking their diet, immune function, intestinal barriers, microbiome, genetics, and environment. So far, 70 participants have been diagnosed with Crohn’s disease, a debilitating condition for which there is currently no cure.

The Leona M. and Harry B. Helmsley Charitable Trust awarded a CA$3.8 million grant to Crohn’s and Colitis Canada to further support the GEM Project. This grant will be supported by another CA$2.6 million from Crohn’s and Colitis Canada. To date, the GEM Project has been supported by a funding commitment of over CA$15 million from both organizations.

“We are grateful that one of the top philanthropic organizations in the world continues to place their trust and their funding to help advance the GEM Project. I have no doubt that the Helmsley Charitable Trust’s continued generosity will help others to see the enormous potential of the GEM Project,” says Mina Mawani, President and CEO of Crohn’s and Colitis Canada. “This study is a linchpin in our relentless search to find the cause of Crohn’s disease. Never before have researchers been this close and we are eager to harness this new information to eliminate the disease once and for all. During this phase of the GEM Project, researchers will seek to develop predictive tests that can identify individuals who will develop the disease, even before symptoms appear.”

While the GEM Project focuses on Crohn’s disease, the research also feeds into the understanding of ulcerative colitis, a similar inflammatory bowel disease (IBD), which could lead to more targeted, and more effective, treatments.

“The challenge of finding the right therapy and a cure for Crohn’s disease requires better understanding of the triggers that precede disease onset. GEM is a one-of-a-kind initiative with the goal of developing a clinically useful prediction tool that will allow identification of individuals at risk and ultimately enable Crohn’s prevention trials,” says Dr. Garabet Yeretssian, Director of the Helmsley Charitable Trust’s Crohn’s Disease Program. “The study aligns with our mission to support impactful ideas and mobilize a global community committed to improving the lives of Crohn’s patients while pursuing a cure.”

With this new philanthropic commitment to the GEM Project, researchers will be validating current and newly discovered biomarkers that precede and predict the onset of Crohn’s disease. These biomarkers will then be utilized to generate a clinically useful prediction tool that can predict the likelihood of developing the disease. This tool will allow identification of individuals at risk and could lead to the development of therapeutic interventions that prevent Crohn’s disease onset and extend remission in Crohn’s patients, hence improving the quality of life of patients.

“We decided, as a family, that this was a critical project that we needed to support and participate in,” explains Kathleen Crispi, a GEM Project participant living in Toronto whose three brothers live with inflammatory bowel disease. “Over the past decade we’ve seen some rapid advances in treatments for Crohn’s and colitis. It’s an exciting time and we wanted to be part of the research project that’s taking the next big step. We’re hopeful that we will see the end of these diseases in our lifetime.”

Dr. Ken Croitoru is the architect and lead investigator of the GEM Project. He and his team at Toronto’s Mount Sinai Hospital are supported by researchers from across Canada and more than 100 recruitment sites around the world.

“While Crohn’s disease is known to have a genetic link, the genetic elements that cause Crohn’s to develop in some people but not others needs to be better understood. With our recruitment goal met and a statistically meaningful patient population now exhibiting Crohn’s disease, we can work to uncover the parameters that lead to the onset of disease,” said Dr. Croitoru, adding that certain biomarkers have already begun to appear more frequently than others and implicate a role for environmental exposures and the gut microbiome.