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Co- Investigators: David Suskind, MD, Shehzad Saeed, MD & Kimberly Braly, RD
Clinician Stakeholders: Jennifer Burgis, MD & Kaylie Nguyen, PNP
Parent Stakeholders: Sheri Pilley, Julie Stone, Gisele Woodward
Patient Stakeholders: Catalina Berenblum
Purpose: PRODUCE study, which stands for Personalized Research on Diet in Ulcerative Colitis and Crohn’s Disease, is a first of its kind nutrition intervention study in IBD. With evidence showing dietary intervention has an impact on disease activity for patients with IBD, the PRODUCE study aims to determine the effectiveness of the Specific Carbohydrate Diet (SCD) in reducing symptoms and inflammatory burden in patients with IBD and compare this to a modified form of the SCD. Over the course of this project, a series of N-of-1 studies will be used to examine how the SCD affects individual patients. In addition, we will combine the results of approximately 100 individual N-of-1 studies to look at the effectiveness of the SCD in the pediatric IBD population.
Primary Outcomes:Â Patient reported outcomes of:
- Daily stool frequency
- Daily stool consistency
- Weekly PROMIS Pain Interference
- Weekly PROMIS GI symptom severity
- Fecal calprotectin
Secondary Outcomes:Â
- Short Crohn’s Disease Activity Index (SCDAI)
- Clinically-evaluated disease activity scores and laboratory markers contained in ICN registry:
- PUCAI and SPCDAI
- Growth
- CRP, HCT, Albumin, ESR
- Microbiome analyses
Funding Source:Â Patient Centered Outcomes Research Institute (PCORI; Awarded January 2017)
Study Period: January 2017 – January 2020
Contact:
Heather Kaplan, MD, MSCEÂ - Co-PI
Lisa Opipari-Arrigan, PhDÂ - Co-PIÂ
Cassandra Dodds - Clinical Research CoordinatorÂ
Lauren Murphy - Clinical Research CoordinatorÂ
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