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Open AccessArticle

Evaluating the Comparative Effectiveness of Two Diets in Pediatric Inflammatory Bowel Disease: A Study Protocol for a Series of N-of-1 Trials

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Perinatal Institute and James M. Anderson Center for Health Systems Excellence, Cincinnati Children’s Hospital Medical Center, Cincinnati, OH 45229, USA
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Department of Pediatrics, University of Cincinnati College of Medicine, Cincinnati, OH 45229, USA
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Division of Behavioral Medicine and Clinical Psychology and James M. Anderson Center for Health Systems Excellence, Cincinnati Children’s Hospital Medical Center, Cincinnati, OH, USA
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Department of Biostatistics, Center for Evidence Synthesis in Health, Brown University School of Public Health, Providence, RI 02912, USA
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Division of Hospital Medicine, Cincinnati Children’s Hospital Medical Center, Cincinnati, OH 45229, USA
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Division of Pediatric Gastroenterology, Dayton Children’s Hospital, Wright State University; Dayton, OH 45404, USA
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Independent Consultant, Division of Pediatric Gastroenterology, Seattle Children’s Hospital, Seattle, WA 98105, USA
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Division of Pediatric Gastroenterology, University of California San Francisco, San Francisco, CA 94158, USA
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Division of Pediatric Gastroenterology, Lucile Packard Children’s Hospital, Stanford Univeristy, Palo Alto, CA 94304, USA
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Parent Working Group, ImproveCareNow, Inc. Burlington, VT 05405, USA
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Division of Gastroenterology, Hepatology and Nutrition Seattle Children’s Hospital, University of Washington, Seattle, WA 98105, USA
*
Author to whom correspondence should be addressed.
These authors contributed equally to this work.
Healthcare 2019, 7(4), 129; https://doi.org/10.3390/healthcare7040129
Received: 23 August 2019 / Revised: 9 October 2019 / Accepted: 23 October 2019 / Published: 1 November 2019
(This article belongs to the Special Issue N-of-1 Trials in Healthcare)
Inflammatory bowel disease (IBD) affects 3 million children and adults in the US. Treatment involves medications with considerable risk profiles. Dietary modification, such as the specific carbohydrate diet (SCD), may be helpful in treating IBD, but there is insufficient evidence of its effectiveness. N-of-1 trials are ideal for addressing this important research question. The Personalized Research on Diet in Ulcerative Colitis and Crohn’s Disease (PRODUCE) study employs a series of 50 individual N-of-1 trials that compare the SCD to a modified SCD. Treatment periods are assigned in blocks of two, with each patient completing two balanced treatment blocks. Patients are randomized to start with the SCD or modified SCD and alternate between conditions for four eight-week periods. A mobile app guides collecting and viewing data, transitioning diets, and reviewing personal results. Primary outcomes include patient reported outcomes (PROs) of stool frequency, stool consistency, pain interference, and gastrointestinal (GI) symptom severity. We examine changes in inflammation via fecal calprotectin. Participants will receive a personalized answer regarding comparative effectiveness between the SCD and a less restrictive diet option (modified SCD), as well as compared to their baseline diet. We will aggregate the results of completed N-of-1 trials across patients to estimate population level comparative effectiveness of these treatments and the effectiveness of each diet.
Keywords: inflammatory bowel disease; Crohn’s disease; ulcerative colitis; specific carbohydrate diet; ImproveCareNow inflammatory bowel disease; Crohn’s disease; ulcerative colitis; specific carbohydrate diet; ImproveCareNow
MDPI and ACS Style

Kaplan, H.C.; Opipari-Arrigan, L.; Schmid, C.H.; Schuler, C.L.; Saeed, S.; Braly, K.L.; Burgis, J.C.; Nguyen, K.; Pilley, S.; Stone, J.; Woodward, G.; Suskind, D.L. Evaluating the Comparative Effectiveness of Two Diets in Pediatric Inflammatory Bowel Disease: A Study Protocol for a Series of N-of-1 Trials. Healthcare 2019, 7, 129.

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