Probiotic Use in Children Undergoing Hematopoietic Stem Cell Transplantation (HSCT)
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|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 ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
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|