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
Primary Outcomes: Patient reported outcomes of:
- Daily stool frequency
- Daily stool consistency
- Weekly PROMIS Pain Interference
- Weekly PROMIS GI symptom severity
- Fecal calprotectin
Secondary Outcomes:
- 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: Patient Centered Outcomes Research Institute (PCORI; Awarded January 2017)
Study Period: January 2017 – January 2020
Contact:
Heather Kaplan, MD, MSCE - Co-PI
Lisa Opipari-Arrigan, PhD - Co-PI
Cassandra Dodds - Clinical Research Coordinator
Lauren Murphy - Clinical Research Coordinator