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NCT03268213 · ClinicalTrials.gov registry record · Early Phase 1
Fecal Microbial Transplantation for C. Difficile and/or Ulcerative Colitis or Indeterminate Colitis
A Early Phase 1 study, sponsored by Stony Brook University.
- Completed
- Registry status
- Early Phase 1
- Development phase
- 12
- Enrollment target
NCT03268213: Completed Early Phase 1 study, sponsored by Stony Brook University.
NCT03268213 is a Early Phase 1 study that has completed, run by Stony Brook University. The registered enrollment target is 12 participants, below the 53-participant average among 2,764 other Early Phase 1 trials with a reported enrollment target (77% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03268213, a Early Phase 1 study, has completed, sponsored by Stony Brook University.
- COMPLETED
- Registry status
- Early Phase 1
- Development phase
- 12 participants
- Enrollment target
Study Summary
Fecal Microbiota Transplantation will be offered to eligible C. difficile patients (does not require Investigational New Drug designation) and to eligible ulcerative colitis or indeterminate colitis patients as Investigational New Drug treatment
Primary Outcome
Number of participants with treatment-related adverse events with grade greater than 2 within one year after FMT will be reported. Safety will be assessed as a report of no new medical condition after the transplant, Tolerability, as recorded by report of no serious adverse events after the transplant and Efficacy of the procedure will be recorded as improvement in clinical symptoms during any clinically indicated colonoscopies after the transplant as compared to before transplant C. Diff pati
Interventions
- BIOLOGICAL Fecal Microbial Transplantation
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 12 participants |
| Start Date | 2013-11 |
| Est. Completion | 2022-02-15 |
| Phase | Early Phase 1 |
What the finished NCT03268213 record still lists
NCT03268213 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 12 participants, a relatively small participant target, below the 53-participant average among 2,764 other Early Phase 1 trials with a reported enrollment target (77% lower).
The record links to 0 conditions, and to 1 intervention - of which Fecal Microbial Transplantation is the first listed.
NCT03268213 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT03268213 about?
NCT03268213 is a clinical study titled "Fecal Microbial Transplantation for C. Difficile and/or Ulcerative Colitis or Indeterminate Colitis". Fecal Microbiota Transplantation will be offered to eligible C. difficile patients (does not require Investigational New Drug designation) and to eligible ulcerative colitis or indeterminate colitis patients as Investigational New Drug treatment
What is the current status of trial NCT03268213?
This trial is currently completed. It is a Early Phase 1 study. The enrollment target is 12 participants. The study started on 2013-11. Estimated completion is 2022-02-15.
What interventions are being tested in trial NCT03268213?
The interventions under investigation include: Fecal Microbial Transplantation (BIOLOGICAL).
Who is sponsoring clinical trial NCT03268213?
This trial is sponsored by Stony Brook University, which has 127 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT03268213's enrollment target sits among peer trials
12 1530th of 2000 higher than 401 of 2,000 other Early Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Early 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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