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NCT04201821 · ClinicalTrials.gov registry record · Phase 1
Fecal Microbial Transplantation for the Treatment of Fecal Incontinence in Women
A Phase 1 study, sponsored by University of Pennsylvania.
- Terminated
- Registry status
- Phase 1
- Development phase
- 10
- Enrollment target
NCT04201821: Clinical Trial Phase 1 study, sponsored by University of Pennsylvania.
NCT04201821 is a Phase 1 study that was terminated before completion, run by University of Pennsylvania. The registered enrollment target is 10 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (83% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04201821, a Phase 1 study, was terminated before completion, sponsored by University of Pennsylvania.
- TERMINATED
- Registry status
- Phase 1
- Development phase
- 10 participants
- Enrollment target
Study Summary
Open label pilot study assessing FMT to treat fecal incontinence in women 50 years of age and older.
Primary Outcome
The St Marsk's Viazy score is a validated patient-reported instrument used to measure fecal incontinence severity. Score ranges from 0-24 with a decrease in the score representing an improvement. A subject has clinical improvement if they have demonstrated a sustained decrease of 4-5 points between the 4-week and 12-week measurements.
Interventions
- BIOLOGICAL fecal microbial transplantation (FMT)
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 10 participants |
| Start Date | 2021-01-14 |
| Est. Completion | 2023-01-18 |
| Phase | Phase 1 |
Why NCT04201821 stopped before completion
NCT04201821 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 10 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (83% lower).
The record links to 0 conditions, and to 1 intervention - of which fecal microbial transplantation (FMT) is the first listed.
NCT04201821 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT04201821 about?
NCT04201821 is a clinical study titled "Fecal Microbial Transplantation for the Treatment of Fecal Incontinence in Women". Open label pilot study assessing FMT to treat fecal incontinence in women 50 years of age and older.
What is the current status of trial NCT04201821?
This trial is currently terminated. It is a Phase 1 study. The enrollment target is 10 participants. The study started on 2021-01-14. Estimated completion is 2023-01-18.
What interventions are being tested in trial NCT04201821?
The interventions under investigation include: fecal microbial transplantation (FMT) (BIOLOGICAL).
Who is sponsoring clinical trial NCT04201821?
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 NCT04201821's enrollment target sits among peer trials
10 1913th of 2000 higher than 46 of 2,000 other Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 1 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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