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NCT02417974 · ClinicalTrials.gov registry record · Phase 2
Prevention of Recurrence of Crohn's Disease by Fecal Microbiota Therapy (FMT)
A Phase 2 study, sponsored by Boston Medical Center.
- Terminated
- Registry status
- Phase 2
- Development phase
- 24
- Enrollment target
NCT02417974: Clinical Trial Phase 2 study, sponsored by Boston Medical Center.
NCT02417974 is a Phase 2 study that was terminated before completion, run by Boston Medical Center. The registered enrollment target is 24 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (82% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02417974, a Phase 2 study, was terminated before completion, sponsored by Boston Medical Center.
- TERMINATED
- Registry status
- Phase 2
- Development phase
- 24 participants
- Enrollment target
Study Summary
The objective of this trial is to assess if Fecal Microbiota Therapy (FMT) can reduce the risk of endoscopic recurrence of Crohn's disease (CD) in patients after intestinal resection. The specific outcomes of FMT to be examined are: 1) endoscopic appearance, 2) clinical symptoms, 3) safety and tolerability, and 4) microbial diversity. The research team hypothesizes that FMT will prevent establishment of "pro-inflammatory" microbiome after surgery, leading to a reduced probability of recurrence of macroscopic inflammation. It is also hypothesized that FMT will be safe and well-tolerated in these patients.
Primary Outcome
Percentage of patients in each arm of the trial who develop endoscopic recurrence within 6 months of ileo-cecal resection. "Endoscopic recurrence" will be defined as a Rutgeert's score of greater than i2
Interventions
- BIOLOGICAL Fecal Microbiota Transplant (FMT)
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 24 participants |
| Start Date | 2015-09 |
| Est. Completion | 2021-02-04 |
| Phase | Phase 2 |
Why NCT02417974 stopped before completion
NCT02417974 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 24 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (82% lower).
The record links to 0 conditions, and to 1 intervention - of which Fecal Microbiota Transplant (FMT) is the first listed.
NCT02417974 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT02417974 about?
NCT02417974 is a clinical study titled "Prevention of Recurrence of Crohn's Disease by Fecal Microbiota Therapy (FMT)". The objective of this trial is to assess if Fecal Microbiota Therapy (FMT) can reduce the risk of endoscopic recurrence of Crohn's disease (CD) in patients after intestinal resection. The specific outcomes of FMT to be examined are: 1) endoscopic appearance, 2) clinical symptoms, 3) safety and toler...
What is the current status of trial NCT02417974?
This trial is currently terminated. It is a Phase 2 study. The enrollment target is 24 participants. The study started on 2015-09. Estimated completion is 2021-02-04.
What interventions are being tested in trial NCT02417974?
The interventions under investigation include: Fecal Microbiota Transplant (FMT) (BIOLOGICAL).
Who is sponsoring clinical trial NCT02417974?
This trial is sponsored by Boston Medical Center, which has 253 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT02417974's enrollment target sits among peer trials
24 1756th of 2000 higher than 217 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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