drugset / Trial / NCT01010867
Probiotic Use in Children Undergoing Hematopoietic Stem Cell Transplantation (HSCT)
Phase 1
Completed
31 enrolled
Columbia University
Johns Hopkins All Children's Hospital · collabNemours Children's Clinic · collab
NaSingle-groupOpen-labelSupportive care
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.
Timeline
- Start
- 2010-02
- Primary completion
- 2014-10
- Completion
- 2014-10
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Lactobacillus plantarum strains 299 and 299v | Other / unclassified | 1e+08 cells/kg | Oral |