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NCT03970200 · ClinicalTrials.gov registry record · Phase 2
Penn Microbiome Therapy (PMT) for Severe-Clostridium Difficile Infection (CDI)
A Phase 2 study, sponsored by University of Pennsylvania.
- Terminated
- Registry status
- Phase 2
- Development phase
- 15
- Enrollment target
NCT03970200: Clinical Trial Phase 2 study, sponsored by University of Pennsylvania.
NCT03970200 is a Phase 2 study that was terminated before completion, run by University of Pennsylvania. The registered enrollment target is 15 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (89% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03970200, a Phase 2 study, was terminated before completion, sponsored by University of Pennsylvania.
- TERMINATED
- Registry status
- Phase 2
- Development phase
- 15 participants
- Enrollment target
Study Summary
This is a randomized, open label, comparative, Phase II study to determine whether fecal microbiota transplant using Penn Microbiome Therapy products helps standard therapy to treat severe Clostridium difficile infection (C diff).
Primary Outcome
The outcome will be satisfied when the subject is discharged from the hospital (not to hospice or palliative care) or, while the subject remains hospitalized, when the following criteria are met for 72 hours: * If radiology study or studies performed, ileus/dilation/megacolon either not noted or noted as resolved * Ileus/megacolon either noted as resolved by any provider documentation or not noted * White Blood Cells (WBC) \<15,000 cells/uL * Serum creatinine decreased, unchanged, or increased
Interventions
- DRUG Antibiotics
- DRUG Penn Microbiome Therapy - 001
- DRUG Penn Microbiome Therapy - 002
- DRUG Penn Microbiome Therapy - 003
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 15 participants |
| Start Date | 2020-01-16 |
| Est. Completion | 2022-05-14 |
| Phase | Phase 2 |
Why NCT03970200 stopped before completion
NCT03970200 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 15 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (89% lower).
The record links to 0 conditions, and to 4 interventions - of which Antibiotics is the first listed.
NCT03970200 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT03970200 about?
NCT03970200 is a clinical study titled "Penn Microbiome Therapy (PMT) for Severe-Clostridium Difficile Infection (CDI)". This is a randomized, open label, comparative, Phase II study to determine whether fecal microbiota transplant using Penn Microbiome Therapy products helps standard therapy to treat severe Clostridium difficile infection (C diff).
What is the current status of trial NCT03970200?
This trial is currently terminated. It is a Phase 2 study. The enrollment target is 15 participants. The study started on 2020-01-16. Estimated completion is 2022-05-14.
What interventions are being tested in trial NCT03970200?
The interventions under investigation include: Antibiotics (DRUG), Penn Microbiome Therapy - 001 (DRUG), Penn Microbiome Therapy - 002 (DRUG), Penn Microbiome Therapy - 003 (DRUG).
Who is sponsoring clinical trial NCT03970200?
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 NCT03970200's enrollment target sits among peer trials
15 1919th of 2000 higher than 60 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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