Dr. James Lewis, M.D., MSCE, professor of medicine and epidemiology at the Perelman School of Medicine, is leading a national research study at the University of Pennsylvania on behalf of the Crohn’s & Colitis Foundation of America (CCFA).
The study focuses on diet as a tool for managing Crohn’s disease symptoms, and has been approved to receive a Patient-Centered Outcomes Research Institute’s (PCORI) funding award of $2.5 million.
Crohn’s is a chronic inflammatory bowel disease (IBD) with no known cure. It currently affects more than 500,000 Americans. The therapies that do exist are not fully effective, and are also associated with several significant side effects.
For IBD patients, diet can be a constant challenge. While the symptoms are not caused by particular foods, certain foods might exacerbate some symptoms in some patients.
The study will assess the effectiveness of the carbohydrate diet and the Mediterranean-style diet to induce remission in Crohn’s disease patients. The study is the result of a patient-generated research question posed through CCFA’s patient-powered research network for CCFA Partners.
“There is little scientific evidence to guide how patients with Crohn’s should modify their diet. Because of this, patients and their physicians face substantial uncertainty about the best diet for Crohn’s,” said Lewis, senior scholar and principal investigator of the study, in a press release. “This study will open the door to a more holistic treatment of Crohn’s disease and provide high quality data and guidance for incorporating diet modifications into the treatment of the disease.”
CCFA Partners’ patient-powered research network mostly focuses on developing a community of IBD citizen scientists who are available to collaborate with researchers to develop and prioritize study ideas, based on their own experiences and observations as patients of IBD themselves.
For the study, Lewis had the help of Jessica Burris, an ulcerative colitis patient and CCFA Partners’ Patient Governance Committee member.
“Doctors often tell patients like me that when it comes to diet, everybody is different – what works for some may not work for others. However, few conclusions have been reached that identifies those differences and how they can be applied to clinical practice,” Burris said. “Dietary interventions must be studied as they have the potential to greatly impact the health and quality of life of individuals living with IBD’s like Crohn’s and ulcerative colitis.”
PCORI is an independent nonprofit that funds research. The National Patient-Centered Clinical Research Network (PCORnet) is a novel initiative that aims to improve the country’s capacity to lead comparative research in an efficient manner by creating a wide representative network for conducting clinical research directly involving patients in its development and execution.
A team of IBD patients will cooperate with Lewis and several other researchers throughout the different stages of the process, including protocol development, study conduct, analysis and interpretation of study data, and dissemination of results.
“This project was selected for PCORI funding not only for its scientific merit and commitment to engaging patients and other stakeholders, but also for its potential to fill an important gap in our health knowledge and give people information to help them weigh the effectiveness of their care options,” said PCORI Executive Director Joe Selby, M.D., MPH. “We look forward to following the study’s progress and working with Dr. Lewis and the CCFA to share the results.”