CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 8 enrolled
Drug / intervention
Fluconazole +6 moredrug
Likely dose
Fluconazole 400mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT02765256
NCT02765256Phase 2Completed
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Fundamental Modification of the Gut Microbiota in the Treatment of Refractory Crohn's Disease

University of Pennsylvania·interventional·Posted May 6, 2016·Updated Feb 6, 2024

In Brief

A Phase 2 clinical trial evaluating Fluconazole, Vancomycin, and 5 other interventions for Crohn's Disease. Completed, enrolled 8 participants across 1 site.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsCrohn's Disease
CountriesUnited States
CollaboratorsChildren's Hospital of Philadelphia, Crohn's and Colitis Foundation

Timeline

Phase 2CompletedFinished
2017201820192020202120222023202420252026
First PostedMay 6, 2016
Enrollment StartAug 1, 2016
Primary CompletionDec 1, 2018
TodayJul 2, 2026
Enrollment to primary: 2.3 yearsPosted 10.2 years ago

Interventions

Fluconazoledrug

400mg orally once daily (Day 1-14)

Vancomycindrug

500mg oral suspension 4 times daily (Day 1-14)

Neomycindrug

neomycin 1000 mg orally three times daily (Days 1-3)

Ciprofloxacindrug

ciprofloxacin 750 mg orally twice daily (Day 4-14)

Polyethylene Glycol 3350drug

238 g dissolved in 64 ounces of Gatorade or Crystal Lite on day 2

Promethazinedrug

PRN (as needed) Promethazine 12.5mg up to every four hours (Days 1-3).

Fluconazole placebodrug

Once daily