A research question posed through the Crohn’s & Colitis Foundation of America (CCFA) Partners Patient-Powered Research Network CCFA Partners – a collaboration between UNC and the CCFA – served as motivation for this study concept.
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For the first time ever, dietary intervention will be the focus of a major national research study of patients with Crohn’s disease. The Patient Centered Outcomes Research Institute (PCORI) has awarded the Crohn’s & Colitis Foundation of America $2.5 million to study the effectiveness of the specific carbohydrate diet and Mediterranean-style diet to induce remission in patients with Crohn’s disease.
The project is the result of a question posed through the CCFA Partners Patient Powered Research Network, which is a collaboration between the UNC School of Medicine and the CCFA.
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.
“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 Michael Kappelman, MD, MPH, associate professor of Pediatrics and Epidemiology, and principal investigator of the CCFA Partners Patient Powered Research Network.
The study will 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.
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.
UNC School of Medicine will also serve as the data management center for this trial, with Robert Sandler, MD, MPH, Nina C. and John T. Sessions Distinguished Professor of Medicine, will lead that aspect of the trial.
For more information, the full announcement from the CCFA is available here.