NEW YORK, March 24, 2016 /PRNewswire-USNewswire/ -- For the first time ever, dietary intervention will be the focus of a major national research study of patients with Crohn's disease. The Crohn's & Colitis Foundation of America (CCFA) announced today that it was awarded $2.5 million from the Patient-Centered Outcomes Research Institute (PCORI) to study the effectiveness of the specific carbohydrate diet and Mediterranean-style diet to induce remission in patients with Crohn's disease. A patient-generated research question posed through CCFA's patient-powered research network (PPRN), CCFA Partners, served as motivation for this study concept.
For patients living with inflammatory bowel diseases (IBD), diet can be a difficult area to navigate. IBD is not caused by eating any one particular food, but certain foods may aggravate symptoms in some patients. There have been few well-designed clinical trials aimed at guiding dietary modifications to help manage symptoms and inflammation in patients with IBD.
"I've always been curious why many IBD patients can only achieve remission via medication, while some are able to manage their symptoms with dietary changes," said Jessica Burris, a member of the patient governance committee of CCFA's PPRN. "When it comes to diet and IBD, patients are often told everybody is different, but little is known regarding what those differences are and how they can be applied to clinical practice. I believe knowledge from this study can positively impact the lives of hundreds of thousands of patients living with Crohn's disease."
A major focus of CCFA's PPRN is to develop a community of IBD citizen scientists partnering with investigators to develop and prioritize research ideas based on their own experiences and observations living with IBD. CCFA Partners has developed a web-based research prioritization process whereby patient members can propose research topics to be answered by the network, and comment and/or vote on the research topics proposed by other patients.
Burris posed the research question on CCFA Partners that Dr. James Lewis, professor of medicine and senior scholar in the Center for Clinical Epidemiology and Biostatistics at the Perelman School of Medicine at the University of Pennsylvania, used as the motivation for this study.
"There is little scientific evidence to guide patients with Crohn's on how they should modify their diet. Because of this, patients and their physicians face substantial uncertainty about the best diet for Crohn's," said Dr. Lewis, the primary investigator for this study. "This study will open the door to more holistic treatment of Crohn's disease and provide high quality data and guidance for incorporating diet modifications into the treatment of IBD."
The study seeks to compare the effectiveness of the specific carbohydrate diet and a Mediterranean-style diet in inducing symptomatic and clinical remission and in reducing the mucosal inflammation in patients with active Crohn's disease. The specific carbohydrate diet was selected because of its popularity among patients and the evolving medical literature suggesting potential therapeutic benefit. The Mediterranean-style diet was chosen as the alternative diet based on the strong evidence of its role in overall health, indirect evidence suggesting a potential benefit for Crohn's disease, and easier implementation in routine life.
"I know that what I eat has an impact on how active my Crohn's disease symptoms are. Certain foods trigger symptoms while others do not," said Andrea Meyer, a Crohn's disease patient playing a lead role on the study's research team. "Despite my success adjusting my diet to manage my disease, I know many patients are wary of using diet as a means of helping them manage their disease because there is limited science supporting diet modifications and they've had limited success trying to figure it out on their own. We need to change the conversation on diet and nutrition and its use in managing IBD symptoms, and we need research data in order to do so."
Patients will enroll in the clinical trial at local clinical sites and will be randomly assigned to one of the diets. Meals will be provided at no cost for six weeks through a meal delivery service, Real Food Works, and patients will have the opportunity to continue purchasing meals afterward. Patient-reported outcomes will be used to assess disease activity on a weekly basis using the CCFA Partners infrastructure. Disease activity will also be assessed by the treating physician before the study begins, at six weeks, and 12 weeks. Mucosal inflammation will be assessed by measuring the concentration of calprotectin in the feces at baseline, six weeks, and 12 weeks.
Consistent with the philosophy of the CCFA's PPRN, a team of IBD patients, including Meyer, will work with Dr. Lewis and other researchers throughout all stages of this exciting project—protocol development, study operations, analysis and interpretation of study data, and the dissemination of research results. The trial will also leverage the data infrastructure developed for CCFA Partners, reducing the time and start-up costs for this project.
"This is an exciting opportunity to demonstrate the potential of CCFA Partners to conduct ground-breaking patient-centered research in an area of great unmet need," said Dr. Michael Kappelman, associate professor at the University of North Carolina at Chapel Hill and principal investigator of the CCFA Partners Patient Powered Research Network.
This study will also partner with two additional patient-powered research networks –Arthritis Patient Partnership with Comparative Effectiveness Researchers (AR-PoWER) and ImproveCareNow. Through the partnership, AR-PoWER will work to generate early data on the potential role of dietary interventions in other inflammatory conditions, including arthritis. ImproveCareNow, a PPRN focused on pediatric IBD, will also collaborate in the conduct and dissemination of the study.
CCFA's award has been approved pending completion of a business and programmatic review by PCORI staff and issuance of a formal award contract.
For more information about CCFA Partners or to enroll, visit www.ccfapartners.org.
About the Patient-Centered Outcomes Research Institute
PCORI is an independent, nonprofit organization authorized by Congress in 2010. Its mission is to fund research that will provide patients, their caregivers, and clinicians with the evidence-based information needed to make better-informed healthcare decisions. For more information about PCORI's funding, visit www.pcori.org.
About the Crohn's & Colitis Foundation of America
The Crohn's & Colitis Foundation of America (CCFA) is the largest non-profit, voluntary, health organization dedicated to finding cures for inflammatory bowel diseases (IBD). CCFA's mission is to cure Crohn's disease and ulcerative colitis, and to improve the quality of life of children and adults who suffer from these diseases. The Foundation works to fulfill its mission by funding research; providing educational resources for patients and their families, medical professionals, and the public; and furnishing supportive services for those afflicted with IBD. For more information visit www.ccfa.org, call 888-694-8872, or email [email protected].
SOURCE Crohn's & Colitis Foundation of America