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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 is a Phase 2 study that was terminated before completion, run by Prolacta Bioscience. The registered enrollment target is 46 participants.
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT06102213
The ClinicalTrials.gov registry entry for NCT06102213 describes a study currently listed as terminated, categorized as Phase 2. The registered enrollment target is 46 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 1 intervention - of which B. infantis (PBCLN-014) and Human Milk Oligosaccharides (HMO) (PBCLN-010) is the first listed.
NCT06102213 reports 0 study locations.
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.
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