NCT02765256View on ClinicalTrials.gov

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

PHASE2CompletedINTERVENTIONAL
Enrollment

8

Participants

Timeline

Start Date

August 31, 2016

Primary Completion Date

December 31, 2018

Study Completion Date

December 31, 2018

Conditions
Crohn's Disease
Interventions
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

Trial Locations (1)

19104

University of Pennsylvania, Philadelphia

All Listed Sponsors
collaborator

Children's Hospital of Philadelphia

OTHER

collaborator

Crohn's and Colitis Foundation

OTHER

lead

University of Pennsylvania

OTHER

NCT02765256 - Fundamental Modification of the Gut Microbiota in the Treatment of Refractory Crohn's Disease | Biotech Hunter | Biotech Hunter