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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: Clinical Trial Phase 1 study, sponsored by Prolacta Bioscience.
NCT03793686 is a Phase 1 study that was terminated before completion, run by Prolacta Bioscience. The registered enrollment target is 26 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (57% lower). According to ClinicalTrials.gov, the official US trial registry.
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.
Primary Outcome
Comparison of adverse event reporting and grading results between groups using physical exams, safety related blood tests, and urinalysis, adverse event reports, and subject complaint logs.
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 |
Why NCT03793686 stopped before completion
NCT03793686 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 26 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (57% lower).
The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.
NCT03793686 does not publish any study locations in the registry export this page uses.
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.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT03793686's enrollment target sits among peer trials
26 1482nd of 2000 higher than 506 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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