New York, NY — The Leona M. and Harry B. Helmsley Charitable Trust announced today it is awarding three grants to fund separate studies to inform evidence-based recommendations on ways that dietary interventions might prevent or treat Crohn’s disease. The grants, totaling $4,698,691, further advance Helmsley’s mission to improve the lives of people living with Crohn’s disease.
The COmbinAtion therapy of dieT with biologicalS for Crohn’s disease (OATS) study and the Inflammatory Bowel Disease Mediterranean Diet (IBDMED) project are collaborations between the Prevention and Disease Management teams of Helmsley’s Crohn’s Disease Program, while the Preventing IBD ONset in Individuals at Risk (PIONIR) trial is funded as part of the Prevention portfolio.
“Previous studies strongly suggest that dietary interventions may be beneficial in Crohn’s disease, but clear evidence-based recommendations are lacking,” said Paul Scholl, Program Director of the Helmsley Charitable Trust Crohn’s Disease Program. “By directly evaluating the effects of specific dietary regimens in preventing and treating Crohn’s disease, these new studies will provide much needed data that can guide future research and inform dietary guidelines for people living with this disease.”
“After developing a diet with positive effects on reducing intestinal inflammation, I was keen to start a dietary intervention trial specifically targeting patients with Crohn’s disease. With the OATS study, we want to prove that an anti-inflammatory diet should be added to the standard of care regimen for patients with Crohn’s disease.”
The OATS study will investigate the safety and efficacy of the Food influence on the Intestinal microbioTa (FIT) diet as an add-on therapy during the induction and maintenance phases of biologic drug therapies in 144 patients with active Crohn’s disease. If successful, the OATS study will demonstrate how a safe, non-invasive, tolerable, and flexible diet can be used in conjunction with patients’ standard biologic medications to facilitate the induction and maintenance of remission in Crohn’s disease patients.
Helmsley is awarding $1.9 million for the OATS project that will be conducted over three years by Katholieke Universiteit Leuven (KU Leuven), the largest university in Belgium and one of the top European Commission-funded institutes of higher education. “The support from Helmsley to KU Leuven to conduct the OATS study is a dream come true,” said Dr. João Sabino, Gastroenterologist and Assistant Professor of Medicine at KU Leuven, and Principal Investigator for this study. “After developing a diet with positive effects on reducing intestinal inflammation, I was keen to start a dietary intervention trial specifically targeting patients with Crohn’s disease. With the OATS study, we want to prove that an anti-inflammatory diet should be added to the standard of care regimen for patients with Crohn’s disease.”
“We aim to investigate whether different genetic backgrounds and environmental influences between Israel and India will result in different biological effects of this nutritional approach. Most importantly, we will make the healthy Mediterranean diet principles accessible to patients with Crohn’s disease and plan to use multidisciplinary team support and advanced tools to promote long-term lifestyle changes in patients and their relatives who are at higher risk for developing Crohn’s disease when compared to the general population.”
The IBDMED study aims to develop a globally-tested nutritional education program to improve adherence to the Mediterranean Diet (MED) in patients with early Crohn’s disease. Researchers will seek to evaluate the effect of the IBDMED program on patients with newly diagnosed Crohn’s disease in India and compare its effects to the same intervention performed in Israel. The IBDMED program also educates patients on how to implement and incorporate MED principles in their lifestyles by providing online dietician support, information, tips, cooking methods, recipes, shopping lists, personalized weekly reports, and monitoring of physical activity with fitness trackers.
Helmsley is awarding $1.4 million for the project that will be conducted over three years by Clalit Health Services, Israel’s largest health fund and the second largest Health Medical Organization in the world. The study will be led by Dr. Iris Dotan, a world-renowned expert in IBD, who is Head of the Division of Gastroenterology at Rabin Medical Center, the flagship hospital of Clalit Health Services.
“We are excited to be collaborating with Helmsley once more on this unique project,” said Dr. Dotan. “We aim to investigate whether different genetic backgrounds and environmental influences between Israel and India will result in different biological effects of this nutritional approach. Most importantly, we will make the healthy Mediterranean diet principles accessible to patients with Crohn’s disease and plan to use multidisciplinary team support and advanced tools to promote long-term lifestyle changes in patients and their relatives who are at higher risk for developing Crohn’s disease when compared to the general population.”
“Helmsley has recently supported two of our innovative projects: the development of the ‘Tasty and Healthy’ diet’s flexible approach for reducing inflammation in Crohn’s disease and the GEM Project to identify first-degree relatives of IBD patients and those who are at risk for developing IBD in the future. Now, the results of these two projects are being combined to explore interventions that reduce the risk of developing IBD. If successful, the PIONIR trial can contribute to a turning point of prevention in the increasing global burden of IBD.”
The PIONIR study will expand on a randomized control trial that Helmsley is currently funding to test the effectiveness of the “Tasty & Healthy” dietary approach in the induction and maintenance of remission of Crohn’s disease. Individuals determined to be at high risk of developing Crohn’s disease will be selected from another Helmsley-funded study, the Genetic, Environmental and Microbial (GEM) Project led by Dr. Kenneth Croitoru. Patients will take part in the PIONIR study to identify the biological impact of “Tasty & Healthy” on GEM risk factors, such as microbiome composition, inflammation, gut permeability, serological markers, and proteomic profiles.
If successful, this trial will provide evidence that a dietary intervention can impact risk factors identified in the GEM Project and thus, by extension, the risk of developing Crohn’s disease. This dietary approach will offer the possibility of maintaining a healthy state in individuals at high risk of developing Crohn’s disease and will likely open the door for larger long-term intervention trials in Crohn’s disease.
Helmsley is awarding $1.3 million for the study to be conducted over two years by the Shaare Zedek Medical Center (SZMC), a nonprofit independent healthcare organization in Israel that provides patient care, educates doctors and health professionals, and conducts a variety of research projects. The project is led by Dr. Dan Turner, Head of the Juliet Kiedan Institute of Pediatric Gastroenterology, Hepatology, and Nutrition at SZMC.
“In collaboration with the Helmsley Charitable Trust, we are excited to move forward with the PIONIR Trial,” said Dr. Turner. “Helmsley has recently supported two of our innovative projects: the development of the ‘Tasty and Healthy’ diet’s flexible approach for reducing inflammation in Crohn’s disease and the GEM Project to identify first-degree relatives of IBD patients and those who are at risk for developing IBD in the future. Now, the results of these two projects are being combined to explore interventions that reduce the risk of developing IBD. If successful, the PIONIR trial can contribute to a turning point of prevention in the increasing global burden of IBD.”
About the Helmsley Charitable Trust
The Leona M. and Harry B. Helmsley Charitable Trust aspires to improve lives by supporting exceptional efforts in the U.S. and around the world in health and select place-based initiatives. Since beginning active grantmaking in 2008, Helmsley has committed more than $2.8 billion for a wide range of charitable purposes. Helmsley’s Crohn’s Disease Program supports impactful ideas and mobilizes a global community committed to improving the lives of Crohn’s disease patients while pursuing a cure.
Media Contact
Laura Fahey, lfahey@helmsleytrust.org, 646-630-1881