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NCT02765256 · ClinicalTrials.gov registry record · Phase 2
Fundamental Modification of the Gut Microbiota in the Treatment of Refractory Crohn's Disease
A Phase 2 study, sponsored by University of Pennsylvania.
- Completed
- Registry status
- Phase 2
- Development phase
- 8
- Enrollment target
NCT02765256: Completed Phase 2 study, sponsored by University of Pennsylvania.
NCT02765256 is a Phase 2 study that has completed, run by University of Pennsylvania. The registered enrollment target is 8 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (94% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02765256, a Phase 2 study, has completed, sponsored by University of Pennsylvania.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 8 participants
- Enrollment target
Study 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.
Primary Outcome
The primary endpoint will be the change in disease activity, as measured by Harvey-Bradshaw Index (HBI) score, between the enrollment visit and Day 15. All participants who withdraw for any reason prior to day 15 will be considered treatment failures. The HBI is a clinical score where points are given for each category below plus number of liquid bowel movements in previous day. A score of 3 or lower is considered remission. A score of 8 or higher is considered severe disease. General Well Bein
Interventions
- DRUG Vancomycin
- DRUG Fluconazole
- DRUG Ciprofloxacin
- DRUG Polyethylene Glycol 3350
- DRUG Neomycin
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 8 participants |
| Start Date | 2016-08 |
| Est. Completion | 2018-12 |
| Phase | Phase 2 |
What the finished NCT02765256 record still lists
NCT02765256 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 8 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (94% lower).
The record links to 0 conditions, and to 5 interventions - of which Vancomycin is the first listed.
NCT02765256 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT02765256 about?
NCT02765256 is a clinical study titled "Fundamental Modification of the Gut Microbiota in the Treatment of Refractory Crohn's Disease". 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.
What is the current status of trial NCT02765256?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 8 participants. The study started on 2016-08. Estimated completion is 2018-12.
What interventions are being tested in trial NCT02765256?
The interventions under investigation include: Vancomycin (DRUG), Fluconazole (DRUG), Ciprofloxacin (DRUG), Polyethylene Glycol 3350 (DRUG), Neomycin (DRUG).
Who is sponsoring clinical trial NCT02765256?
This trial is sponsored by University of Pennsylvania, which has 1,423 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT02765256's enrollment target sits among peer trials
8 1990th of 2000 higher than 5 of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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