NCT02765256

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

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 8 (actual)
• Sponsor: University of Pennsylvania · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Crohn's Disease

Interventions

Type	Name	Description
DRUG	Fluconazole	400mg orally once daily (Day 1-14)
DRUG	Vancomycin	500mg oral suspension 4 times daily (Day 1-14)
DRUG	Neomycin	neomycin 1000 mg orally three times daily (Days 1-3)
DRUG	Ciprofloxacin	ciprofloxacin 750 mg orally twice daily (Day 4-14)
DRUG	Polyethylene Glycol 3350	238 g dissolved in 64 ounces of Gatorade or Crystal Lite on day 2
DRUG	Promethazine	PRN (as needed) Promethazine 12.5mg up to every four hours (Days 1-3).
DRUG	Fluconazole placebo	Once daily

Timeline

• Start date: 2016-08-01
• Primary completion: 2018-12-01
• Completion: 2018-12-01
• First posted: 2016-05-06
• Last updated: 2024-02-06
• Results posted: 2021-02-08

Locations

1 site across 1 country: United States