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NCT02318992 · ClinicalTrials.gov registry record · Phase 1
Fresh, Frozen or Lyophilized Fecal Microbiota Transplantation for Multiple Recurrent C. Difficile Associated Diarrhea
A Phase 1 study, sponsored by The University of Texas Health Science Center, Houston.
- Completed
- Registry status
- Phase 1
- Development phase
- 79
- Enrollment target
NCT02318992: Completed Phase 1 study, sponsored by The University of Texas Health Science Center, Houston.
NCT02318992 is a Phase 1 study that has completed, run by The University of Texas Health Science Center, Houston. The registered enrollment target is 79 participants, above the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (32% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02318992, a Phase 1 study, has completed, sponsored by The University of Texas Health Science Center, Houston.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 79 participants
- Enrollment target
Study Summary
The objective of the study is to investigate the efficacy of fresh, frozen or lyophilized fecal microbiota transplantation (FMT) via colonoscopy in patients with recurrent C. difficile associated diarrhea (RCDAD). Frozen, lyophilized or fresh fecal microbiota transplantation (FMT) inoculum will be generated from well-screened healthy volunteer donors of ≥150 gram/sample. Delivery of FMT will be performed colonoscopically. Fecal samples from donors and recipients will be saved for later metagenomic studies to characterize the microbiome of the gut in patients before and after FMT.
Primary Outcome
Any untoward medical occurrence associated with the use of PRIM-DJ2727 whether or not considered drug related is considered as an adverse event (AE)
Interventions
- BIOLOGICAL Fecal Microbiota
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 79 participants |
| Start Date | 2013-08 |
| Est. Completion | 2018-04 |
| Phase | Phase 1 |
What the finished NCT02318992 record still lists
NCT02318992 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 79 participants, a relatively small participant target, above the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (32% higher).
The record links to 0 conditions, and to 1 intervention - of which Fecal Microbiota is the first listed.
NCT02318992 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT02318992 about?
NCT02318992 is a clinical study titled "Fresh, Frozen or Lyophilized Fecal Microbiota Transplantation for Multiple Recurrent C. Difficile Associated Diarrhea". The objective of the study is to investigate the efficacy of fresh, frozen or lyophilized fecal microbiota transplantation (FMT) via colonoscopy in patients with recurrent C. difficile associated diarrhea (RCDAD). Frozen, lyophilized or fresh fecal microbiota transplantation (FMT) inoculum will be g...
What is the current status of trial NCT02318992?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 79 participants. The study started on 2013-08. Estimated completion is 2018-04.
What interventions are being tested in trial NCT02318992?
The interventions under investigation include: Fecal Microbiota (BIOLOGICAL).
Who is sponsoring clinical trial NCT02318992?
This trial is sponsored by The University of Texas Health Science Center, Houston, which has 732 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT02318992's enrollment target sits among peer trials
79 696th of 2000 higher than 1,304 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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