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NCT06102213 · ClinicalTrials.gov registry record · Phase 2
Study To Evaluate The Safety And Efficacy of PBCLN-010 In Combination With PBCLN-014 in Participants Receiving Allogeneic Hematopoietic Cell Transplantation
A Phase 2 study, sponsored by Prolacta Bioscience.
- Terminated
- Registry status
- Phase 2
- Development phase
- 46
- Enrollment target
NCT06102213: Clinical Trial Phase 2 study, sponsored by Prolacta Bioscience.
NCT06102213 is a Phase 2 study that was terminated before completion, run by Prolacta Bioscience. The registered enrollment target is 46 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (65% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT06102213, a Phase 2 study, was terminated before completion, sponsored by Prolacta Bioscience.
- TERMINATED
- Registry status
- Phase 2
- Development phase
- 46 participants
- Enrollment target
Study Summary
This is a Phase 2a, open-label, multicenter study to evaluate the safety and efficacy of HMO (PBCLN-010) and B. infantis (PBCLN-014) on the gut microbiome and GI domination by pathobionts in participants receiving allo-HCT. Approximately 60 participants will be enrolled in this study, and all participants will undergo screening assessments up to 28 days before the first study drug dose (D 7). Participants meeting all the eligibility criteria based on the screening assessments will be enrolled and randomly assigned to 1 of the 3 cohorts: * Cohort A (HMO 9.0 g and B. infantis) BID * Cohort B (HMO 4.5 g and B. infantis) BID * Cohort C (Control Cohort): Participants in this cohort will not receive any study drug.
Interventions
- DRUG B. infantis (PBCLN-014) and Human Milk Oligosaccharides (HMO) (PBCLN-010)
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 46 participants |
| Start Date | 2023-09-18 |
| Est. Completion | 2024-08-12 |
| Phase | Phase 2 |
Why NCT06102213 stopped before completion
NCT06102213 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 46 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (65% lower).
The record links to 0 conditions, and to 1 intervention - of which B. infantis (PBCLN-014) and Human Milk Oligosaccharides (HMO) (PBCLN-010) is the first listed.
NCT06102213 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT06102213 about?
NCT06102213 is a clinical study titled "Study To Evaluate The Safety And Efficacy of PBCLN-010 In Combination With PBCLN-014 in Participants Receiving Allogeneic Hematopoietic Cell Transplantation". This is a Phase 2a, open-label, multicenter study to evaluate the safety and efficacy of HMO (PBCLN-010) and B. infantis (PBCLN-014) on the gut microbiome and GI domination by pathobionts in participants receiving allo-HCT. Approximately 60 participants will be enrolled in this study, and all parti...
What is the current status of trial NCT06102213?
This trial is currently terminated. It is a Phase 2 study. The enrollment target is 46 participants. The study started on 2023-09-18. Estimated completion is 2024-08-12.
What interventions are being tested in trial NCT06102213?
The interventions under investigation include: B. infantis (PBCLN-014) and Human Milk Oligosaccharides (HMO) (PBCLN-010) (DRUG).
Who is sponsoring clinical trial NCT06102213?
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 NCT06102213's enrollment target sits among peer trials
46 1286th of 2000 higher than 705 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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