The Patient-Centered Outcomes Research Institute has awarded $2.5 million to the Crohn’s & Colitis Foundation of America to fund a national research study of the specific carbohydrate diet and Mediterranean-style diet for induction of remission in patients with Crohn’s disease, according to a CCFA press release.
“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,” Michael Kappelman, MD, associate professor at the University of North Carolina at Chapel Hill and principal investigator of the CCFA Partners PPRN, said in the press release.
Jessica Burris, a member of the patient governance committee of CCFA’s PPRN, submitted a research question via CCFA Partners, the foundation’s patient-powered research network (PPRN), which aims to bring IBD patients and investigators together to develop ideas for research based on their experiences with the disease.
“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,” Burris said in the 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.”
Burris’ research question, which she submitted via CCFA Partners’ web-based research prioritization process, gave James Lewis, MD, 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, the idea 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,” Lewis said in the press release. “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.”
Well-designed clinical trials of dietary interventions in IBD are lacking, according to the press release. Thus, this randomized trial will compare the efficacy of the specific carbohydrate diet and a Mediterranean-style diet for induction of symptomatic and clinical remission, and reduction of mucosal inflammation in patients with active Crohn’s disease. Evidence suggests both diets may have potential therapeutic benefits.
“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,” Andrea Meyer, a Crohn’s disease patient playing a lead role on the study’s research team, said in the press release. “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.”
Patient-reported outcomes will be assessed weekly, disease activity will be assessed at baseline and 6 and 12 weeks, and mucosal inflammation will be also assessed by fecal calprotectin concentrations at baseline and 6 and 12 weeks, according to the press release. IBD patients will also participate in protocol development, study operations, and analysis, interpretation and dissemination of study data. Moreover, the study will partner with the Arthritis Patient Partnership with Comparative Effectiveness Researchers to generate early data on dietary interventions in other inflammatory conditions. ImproveCareNow, a pediatric IBD-focused PPRN, will also collaborate with the study research team.