文章基本信息

标题：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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作者：Heather C. Kaplan ; Lisa Opipari-Arrigan ; Christopher H. Schmid 等
期刊名称：Healthcare
电子版ISSN：2227-9032
出版年度：2019
卷号：7
期号：4
页码：129-142
DOI：10.3390/healthcare7040129
出版社：MDPI Publishing
摘要：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.
关键词：inflammatory bowel disease; Crohn’s disease; ulcerative colitis; specific carbohydrate diet; ImproveCareNow inflammatory bowel disease ; Crohn’s disease ; ulcerative colitis ; specific carbohydrate diet ; ImproveCareNow