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NCT03298048 · ClinicalTrials.gov registry record · Phase 2
Dose Ranging Study of the Safety and Efficacy of Orally Administered Lyophilized Fecal Microbiota Product (PRIM-DJ2727) for the Treatment of Recurrent Clostridium Difficile Infection (CDI)
A Phase 2 study, sponsored by The University of Texas Health Science Center, Houston.
- Terminated
- Registry status
- Phase 2
- Development phase
- 17
- Enrollment target
NCT03298048: Clinical Trial Phase 2 study, sponsored by The University of Texas Health Science Center, Houston.
NCT03298048 is a Phase 2 study that was terminated before completion, run by The University of Texas Health Science Center, Houston. The registered enrollment target is 17 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (87% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03298048, a Phase 2 study, was terminated before completion, sponsored by The University of Texas Health Science Center, Houston.
- TERMINATED
- Registry status
- Phase 2
- Development phase
- 17 participants
- Enrollment target
Study Summary
To establish optimal dosing of lyophilized Fecal microbiota transplantation (FMT) product in the treatment of recurrent C. difficile infection
Interventions
- BIOLOGICAL Low fecal microbiota dose
- BIOLOGICAL Mid fecal microbiota dose
- BIOLOGICAL High fecal microbiota dose
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 17 participants |
| Start Date | 2017-12-21 |
| Est. Completion | 2019-06-30 |
| Phase | Phase 2 |
Why NCT03298048 stopped before completion
NCT03298048 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 17 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (87% lower).
The record links to 0 conditions, and to 3 interventions - of which Low fecal microbiota dose is the first listed.
NCT03298048 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT03298048 about?
NCT03298048 is a clinical study titled "Dose Ranging Study of the Safety and Efficacy of Orally Administered Lyophilized Fecal Microbiota Product (PRIM-DJ2727) for the Treatment of Recurrent Clostridium Difficile Infection (CDI)". To establish optimal dosing of lyophilized Fecal microbiota transplantation (FMT) product in the treatment of recurrent C. difficile infection
What is the current status of trial NCT03298048?
This trial is currently terminated. It is a Phase 2 study. The enrollment target is 17 participants. The study started on 2017-12-21. Estimated completion is 2019-06-30.
What interventions are being tested in trial NCT03298048?
The interventions under investigation include: Low fecal microbiota dose (BIOLOGICAL), Mid fecal microbiota dose (BIOLOGICAL), High fecal microbiota dose (BIOLOGICAL).
Who is sponsoring clinical trial NCT03298048?
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 NCT03298048's enrollment target sits among peer trials
17 1903rd of 2000 higher than 93 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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