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NCT01010867 · ClinicalTrials.gov registry record · Phase 1
Probiotic Use in Children Undergoing Hematopoietic Stem Cell Transplantation (HSCT)
A Phase 1 study, sponsored by Columbia University.
- Completed
- Registry status
- Phase 1
- Development phase
- 31
- Enrollment target
NCT01010867: Completed Phase 1 study, sponsored by Columbia University.
NCT01010867 is a Phase 1 study that has completed, run by Columbia University. The registered enrollment target is 31 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (48% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01010867, a Phase 1 study, has completed, sponsored by Columbia University.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 31 participants
- Enrollment target
Study Summary
Primary Objective: 1\. To evaluate the safety of orally administered Lactobacillus plantarum strains 299 and 299v, a probiotic, in patients undergoing allogeneic myeloablative HSCT, as measured by incidence of Lactobacillus plantarum bacteremia. Secondary Objectives: 1. To investigate the feasibility of administering Lactobacillus plantarum 299 and 299v to children and adolescents undergoing HSCT. 2. To describe the overall incidence of bacteremia in HSCT patients who have been administered Lactobacillus plantarum. 3. To describe the overall incidence of acute graft versus host disease (GVHD) in HSCT patients who have been administered Lactobacillus plantarum.
Interventions
- DRUG Lactobacillus plantarum strains 299 and 299v
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 31 participants |
| Start Date | 2010-02 |
| Est. Completion | 2014-10 |
| Phase | Phase 1 |
What the finished NCT01010867 record still lists
NCT01010867 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 31 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (48% lower).
The record links to 0 conditions, and to 1 intervention - of which Lactobacillus plantarum strains 299 and 299v is the first listed.
NCT01010867 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01010867 about?
NCT01010867 is a clinical study titled "Probiotic Use in Children Undergoing Hematopoietic Stem Cell Transplantation (HSCT)". Primary Objective: 1\. To evaluate the safety of orally administered Lactobacillus plantarum strains 299 and 299v, a probiotic, in patients undergoing allogeneic myeloablative HSCT, as measured by incidence of Lactobacillus plantarum bacteremia. Secondary Objectives: 1. To investigate the feasibi...
What is the current status of trial NCT01010867?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 31 participants. The study started on 2010-02. Estimated completion is 2014-10.
What interventions are being tested in trial NCT01010867?
The interventions under investigation include: Lactobacillus plantarum strains 299 and 299v (DRUG).
Who is sponsoring clinical trial NCT01010867?
This trial is sponsored by Columbia University, which has 958 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01010867's enrollment target sits among peer trials
31 1322nd of 2000 higher than 669 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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