drugset / Trial / NCT02765256
Fundamental Modification of the Gut Microbiota in the Treatment of Refractory Crohn's Disease
Phase 2
Completed
8 enrolled
University of Pennsylvania
Children's Hospital of Philadelphia · collabCrohn's and Colitis Foundation · collab
RandomizedParallel-groupQuadruple-blindTreatment
Summary
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) that is refractory to conventional, immunosuppressive therapy.
Timeline
- Start
- 2016-08
- Primary completion
- 2018-12
- Completion
- 2018-12
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Fluconazole | Small molecule | 400 mg | Oral |
| Background | Ciprofloxacin | Small molecule | 750 mg | Oral |
| Background | Neomycin | Unknown | 1000 mg | Oral |
| Background | Polyethylene Glycol 3350 | Other / unclassified | 238 g | — |
| Background | Promethazine | Small molecule | 12.5 mg | — |
| Background | Vancomycin | Other / unclassified | 500 mg | Oral |