Overview

Pilot Study of Fundamental Modification of the Gut Microbiota in the Treatment of Refractory Crohn's Disease

Status:
Completed
Trial end date:
2020-12-31
Target enrollment:
Participant gender:
Summary
The purpose of this study is to determine the effect of a novel gut microbiota-targeted therapeutic regimen (bowel lavage and antibiotics with or without an antifungal) in the management of active Crohn's Disease (CD) or indeterminate colitis (IBDU) that is refractory to conventional, immunosuppressive therapy. In addition, the study will determine the effect of PEG lavage alone on fecal calprotectin and gut microbiota in patients who are undergoing a PEG lavage for clinical care.
Phase:
Phase 2
Details
Lead Sponsor:
Children's Hospital of Philadelphia
Collaborators:
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
University of Pennsylvania
Treatments:
Ciprofloxacin
Fluconazole
Neomycin
Polyethylene glycol 3350
Vancomycin