The Crohn’s & Colitis Foundation of America (CCFA) has been given $2.5 million by the Patient-Centered Outcomes Research Institute to investigate the value of a carbohydrate-rich diet and a Mediterranean-style diet in preventing relapse in Crohn’s disease patients currently in remission. The study concept was derived from a question posed on CCFA Partners, the foundation’s patient-powered research network (PPRN).
Dietary changes can be a difficult for people with inflammatory bowel diseases (IBD), because certain foods can aggravate disease symptoms. Well-designed clinical trials assessing dietary modifications that might help with symptom management and inflammation, also, are few.
“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,” Jessica Burris, a member of the PPRN’s patient governance committee, said in a press release.”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.”
PPRN is a community of IBD patients working with scientists to promote research ideas based on their own disease experiences. CCFA Partners’ research model uses a web-based platform for patient members to suggest research topics, with proposals answered by the network, and to comment on research ideas suggested by other patients.
Burris posed the diet-related question on the network, and Dr. James Lewis used it as motivation for the 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, a professor at the Perelman School of Medicine, University of Pennsylvania, and the study’s primary investigator. “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 “Food and Crohn’s Exacerbation Study (FACES)” will compare the efficacy of a specific carbohydrate diet and a Mediterranean-style diet in inducing remission of symptoms and reducing mucosal inflammation in patients with active Crohn’s disease.
“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 working with the 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 … 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.”
People enrolled will be randomized to one of the two diets at local clinical sites. Free meals will be provided for six weeks through a meal-delivery service, Real Food Works. Afterward, patients can continue purchasing meals.
Assessment of disease activity will be performed through patient-reported outcomes on a weekly basis using the CCFA Partners infrastructure. The treating physician will measure disease activity at study baseline and again at six and 12 weeks. Mucosal inflammation will be measured by the concentration of calprotectin in feces at baseline and again at week six and 12.
“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 PPRN.
The study will also be conducted in collaboration with other patient-centered research networks, the Arthritis Patient Partnership with Comparative Effectiveness Researchers (AR-PoWER) and ImproveCareNow, a pediatric IBD network.
Crohn’s disease and ulcerative colitis affect approximately 1.4 million people in the United States, with medical costs estimated at over $6 billion annually.