PCORI Project to Examine Dietary Interventions for Crohn’s Disease

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A national research study to focus on diet as a tool for managing Crohn’s disease symptoms, led by James Lewis, MD, MSCE, a professor of Medicine and Epidemiology at the Perelman School of Medicine at the University of Pennsylvania, on behalf of the Crohn’s & Colitis Foundation of America (CCFA), has been approved to receive a $2.5 million funding award by the Patient-Centered Outcomes Research Institute (PCORI).

The study, which will examine the effectiveness of the specific carbohydrate diet and the Mediterranean-style diet to induce remission in patients with Crohn’s disease, is the result of a patient-generated research question posed through CCFA’s patient-powered research network – CCFA Partners.

Crohn’s disease is a chronic, inflammatory bowel disease (IBD) which currently has no cure and affects more than 500,000 Americans.  Existing therapies are not completely effective and are associated with substantial risks of side effects.   For patients living with IBD, diet can be a difficult area to navigate.  While not caused by eating any one particular food, certain foods may aggravate symptoms in some patients.

“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, the principal investigator for the study, and senior scholar in the Center for Clinical Epidemiology and Biostatistics at Penn. “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.”

A major focus of CCFA Partners patient-powered research network is to develop a community of IBD citizen scientists partnering with researchers to develop and prioritize study ideas based on their own experiences and observations from living with IBD.  Lewis drew from ulcerative colitis patient, and CCFA Partners’ patient governance committee member, Jessica Burris’ experience to formulate this study.

“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.”

Consistent with the philosophy of the CCFA Partners patient-powered research network, a team of IBD patients will work with Lewis and other researchers throughout all stages of the study – protocol development, study conduct, analysis and interpretation of study data, and dissemination of research 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, MD, MPH.  “We look forward to following the study’s progress and working with Dr. Lewis and the CCFA to share the results.”

PCORI is an independent, non-profit organization authorized by Congress in 2010 to fund research that will provide patients, their caregivers and clinicians with the evidence-based information they need to make better-informed healthcare decisions.

PCORnet, the National Patient-Centered Clinical Research Network, is an innovative initiative of PCORI that aims to improve the nation’s capacity to conduct comparative clinical effectiveness research efficiently by creating a large, highly representative network for conducting clinical outcomes research that directly involves patients in the development and execution of research.

CCFA’s award has been approved pending completion of a business and programmatic review by PCORI staff and issuance of a formal award contact.