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NCT03793686 · ClinicalTrials.gov registry record · Phase 1
A Study of Safety of PBCLN-003 Following Antibiotic Therapy in Subjects With C.Difficile-associated Diarrhea
A Phase 1 study, sponsored by Prolacta Bioscience.
- Terminated
- Registry status
- Phase 1
- Development phase
- 26
- Enrollment target
NCT03793686 is a Phase 1 study that was terminated before completion, run by Prolacta Bioscience. The registered enrollment target is 26 participants.
The verdict
NCT03793686, a Phase 1 study, was terminated before completion, sponsored by Prolacta Bioscience.
- TERMINATED
- Registry status
- Phase 1
- Development phase
- 26 participants
- Enrollment target
Study Summary
This Phase I double blind, randomized clinical study to evaluate the safety of human milk oligosaccharides (HMO) is designed to assess the safety and dosage ranging of PBCLN-003 in adults with Clostridium difficile-associated diarrhea (CDAD). Within 3 dose cohort, subjects will be randomized in a 3:1 ratio to receive PBCLN-003 or placebo.
Interventions
- DRUG Placebo
- DRUG PBCLN-003
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 26 participants |
| Start Date | 2018-12-06 |
| Est. Completion | 2020-09-01 |
| Phase | Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT03793686
The ClinicalTrials.gov registry entry for NCT03793686 describes a study currently listed as terminated, categorized as Phase 1. The registered enrollment target is 26 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Prolacta Bioscience, which has 7 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.
NCT03793686 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT03793686 about?
NCT03793686 is a clinical study titled "A Study of Safety of PBCLN-003 Following Antibiotic Therapy in Subjects With C.Difficile-associated Diarrhea". This Phase I double blind, randomized clinical study to evaluate the safety of human milk oligosaccharides (HMO) is designed to assess the safety and dosage ranging of PBCLN-003 in adults with Clostridium difficile-associated diarrhea (CDAD). Within 3 dose cohort, subjects will be randomized in a 3:...
What is the current status of trial NCT03793686?
This trial is currently terminated. It is a Phase 1 study. The enrollment target is 26 participants. The study started on 2018-12-06. Estimated completion is 2020-09-01.
What interventions are being tested in trial NCT03793686?
The interventions under investigation include: Placebo (DRUG), PBCLN-003 (DRUG).
Who is sponsoring clinical trial NCT03793686?
This trial is sponsored by Prolacta Bioscience, which has 7 total clinical trials registered on ClinicalTrials.gov.
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