drugset / Trial / NCT03476317
Pilot Study of Fundamental Modification of the Gut Microbiota in the Treatment of Refractory Crohn's Disease
Phase 2
Completed
10 enrolled
Children's Hospital of Philadelphia
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) · collabUniversity of Pennsylvania · collab
RandomizedParallel-groupQuadruple-blindTreatment
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.
Timeline
- Start
- 2018-07-12
- Primary completion
- 2020-12-31
- Completion
- 2020-12-31
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Fluconazole | Small molecule | — | Oral |
| Background | Ciprofloxacin | Small molecule | — | Oral |
| Background | Neomycin | Unknown | — | Oral |
| Background | Vancomycin | Other / unclassified | — | Oral |
| Background | polyethylene glycol | Other / unclassified | — | — |