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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 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.
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT03298048
The ClinicalTrials.gov registry entry for NCT03298048 describes a study currently listed as terminated, categorized as Phase 2. The registered enrollment target is 17 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is The University of Texas Health Science Center, Houston, which has 732 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 3 interventions - of which Low fecal microbiota dose is the first listed.
NCT03298048 reports 0 study locations.
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.
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