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Probiotic Use in Children Undergoing Hematopoietic Stem Cell Transplantation (HSCT)

NCT01010867 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 31

Last updated 2017-07-13

Study results available
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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.

Conditions

  • Hematopoietic Organs; Disorder

Interventions

DRUG

Lactobacillus plantarum strains 299 and 299v

Patients will receive a daily dose of Lactobacillus plantarum: 1 x10\^8 CFU/kg/day. This supplement will be supplied in sachets of powder and will be mixed in water (certain water-based liquid) that is no warmer that 37o C. Colony forming units (CFU)

Sponsors & Collaborators

  • Johns Hopkins All Children's Hospital

    collaborator OTHER

  • Nemours Children's Clinic

    collaborator OTHER

  • Columbia University

    lead OTHER

Principal Investigators

  • Michael Neider, MD · Johns Hopkins All Children's Hospital

  • Monica Bhatia, MD · Columbia University

  • Elena J Ladas, PhD, RD · Columbia University

Study Design

Allocation
NA
Purpose
SUPPORTIVE_CARE
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
2 Years
Max Age
17 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2010-02-28
Primary Completion
2014-10-31
Completion
2014-10-31
FDA Drug
Yes

Countries

  • United States

Study Locations

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Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01010867 on ClinicalTrials.gov