The Genetic, Environmental, Microbial (GEM) Project — the world’s largest clinical study investigating the causes of Crohn’s disease — has reached its goal of recruiting 5,000 participants, Crohn’s and Colitis Canada recently announced.

Launched in 2008 at Mount Sinai Hospital in Toronto, Canada, the GEM Project is a prospective study that monitors the development of Crohn’s disease in healthy individuals who have a sibling or parent with the disease.

Researchers are specifically looking at participants’ diet, immune function, intestinal barriers, microbiome (i.e., gut bacteria), genetics, and the environment in an effort to determine factors that may trigger disease development.

To support the GEM research program, the Leona M. and Harry B. Helmsley Charitable Trust awarded CA$3.8 million (US$103.6 million) to Crohn’s and Colitis Canada. This grant is on top of another CA$2.6 million (US$1.95 million) from Crohn’s and Colitis Canada itself. So far, the project has been awarded more than CA$15 million (US$11.26 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,” Mina Mawani, president and CEO of Crohn’s and Colitis Canada, said in a press release.

With the help of this new funding, researchers will be validating currently known and new biomarkers that can predict the onset of Crohn’s disease before symptoms appear. These markers will be used to develop a clinically useful prediction tool that can determine patients who are at risk of developing the disease.

Moreover, the findings could aid in the development of medicines that can prevent the disease, and extend remission in Crohn’s patients, improving their quality of life.

“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,” said Garabet Yeretssian, PhD, 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.”

Among the participants recruited to date, 70 have been diagnosed with Crohn’s disease, providing valuable information in helping to determine the cause of this incurable disease. Ultimately, the project aims to find a way to completely prevent the development of Crohn’s disease.

“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,” Mawani said.

While it is mainly focused on finding a cause of Crohn’s disease, the GEM project can also help develop a better understanding of another inflammatory bowel disease — ulcerative colitis — which could eventually lead to more targeted, effective treatments.

“We decided, as a family, that this was a critical project that we needed to support and participate in,” said Kathleen Crispi, a GEM Project participant who has three brothers 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.”