Probiotic Use in Children Undergoing Hematopoietic Stem Cell Transplantation (HSCT)
|ClinicalTrials.gov Identifier: NCT01010867|
Recruitment Status : Completed
First Posted : November 10, 2009
Results First Posted : July 13, 2017
Last Update Posted : July 13, 2017
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.
- To investigate the feasibility of administering Lactobacillus plantarum 299 and 299v to children and adolescents undergoing HSCT.
- To describe the overall incidence of bacteremia in HSCT patients who have been administered Lactobacillus plantarum.
- To describe the overall incidence of acute graft versus host disease (GVHD) in HSCT patients who have been administered Lactobacillus plantarum.
|Condition or disease||Intervention/treatment||Phase|
|Hematopoietic Organs; Disorder||Drug: Lactobacillus plantarum strains 299 and 299v||Phase 1|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||31 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Primary Purpose:||Supportive Care|
|Official Title:||A Limited Institution Pilot Trial Evaluating the Safety of Administering the Probiotic, Lactobacillus Plantarum, to Children and Adolescents Undergoing Allogenic Hematopoietic Stem Cell Transplantation (HSCT) - A Pilot Study|
|Study Start Date :||February 2010|
|Primary Completion Date :||October 2014|
|Study Completion Date :||October 2014|
Experimental: Lactobacillus plantarum
There is a single intervention arm in this study. Target accrual for the intervention is 30 subjects. Subjects receive supplementation with Lactobacillus plantarum strains 299 and 299v.
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)
Other Name: Probiotics
- Number of Lactobacillus Plantarum Bacteremia Infections [ Time Frame: 36 days (day -7 to +28 of HSCT) ]
- Adherence With the Prescribed Dose, Measured as the Percentage of Prescribed Probiotic Doses [ Time Frame: 22 days (day -7 to +14 of HSCT) ]To determine the feasibility of administration of L. plantarum 299 and 299v. The treatment is considered feasible for a patient if he/she received at least 50% of the probiotic dose (>= 11 days of treatment).
- Number of Non-lactobacillus Infections [ Time Frame: 36 days (day -7 to +28 of HSCT) ]To determine incidence of bacteremia in HSCT patients who have been administered lactobacillus plantarum.
- Number of Acute Graft Versus Host Disease (GVHD) Events in HSCT Patients Who Have Been Administered Lactobacillus Plantarum [ Time Frame: Up to Day +100 of HSCT ]
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01010867
|United States, Florida|
|Nemours Children's Clinic|
|Jacksonville, Florida, United States, 32207|
|All Children's Hospital|
|Saint Petersburg, Florida, United States, 33701|
|United States, New York|
|Columbia Universtiy Medical Center|
|New York, New York, United States, 10032|
|Principal Investigator:||Michael Neider, MD||Johns Hopkins All Children's Hospital|
|Principal Investigator:||Monica Bhatia, MD||Columbia University|
|Principal Investigator:||Elena J Ladas, PhD, RD||Columbia University|