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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01010867
First Posted: November 10, 2009
Last Update Posted: July 13, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborators:
Johns Hopkins All Children's Hospital
Nemours Children's Clinic
Information provided by (Responsible Party):
Columbia University
Results First Submitted: November 9, 2015  
Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Supportive Care
Condition: Hematopoietic Organs; Disorder
Intervention: Drug: Lactobacillus plantarum strains 299 and 299v

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
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Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
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Reporting Groups
  Description
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.

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)


Participant Flow:   Overall Study
    Lactobacillus Plantarum
STARTED   31 
COMPLETED   30 
NOT COMPLETED   1 
< 50% adherence to probiotic                1 



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
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Reporting Groups
  Description
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.

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.


Baseline Measures
   Lactobacillus Plantarum 
Overall Participants Analyzed 
[Units: Participants]
 31 
Age 
[Units: Years]
Mean (Standard Deviation)
 7.8  (4.7) 
Sex: Female, Male 
[Units: Participants]
Count of Participants
 
Female      14  45.2% 
Male      17  54.8% 
Race (NIH/OMB) 
[Units: Participants]
Count of Participants
 
American Indian or Alaska Native      0   0.0% 
Asian      2   6.5% 
Native Hawaiian or Other Pacific Islander      0   0.0% 
Black or African American      12  38.7% 
White      17  54.8% 
More than one race      0   0.0% 
Unknown or Not Reported      0   0.0% 
Region of Enrollment 
[Units: Participants]
 
United States   31 


  Outcome Measures
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1.  Primary:   Number of Lactobacillus Plantarum Bacteremia Infections   [ Time Frame: 36 days (day -7 to +28 of HSCT) ]

2.  Secondary:   Adherence With the Prescribed Dose, Measured as the Percentage of Prescribed Probiotic Doses   [ Time Frame: 22 days (day -7 to +14 of HSCT) ]

3.  Secondary:   Number of Non-lactobacillus Infections   [ Time Frame: 36 days (day -7 to +28 of HSCT) ]

4.  Secondary:   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 ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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  More Information
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Certain Agreements:  
All Principal Investigators ARE employed by the organization sponsoring the study.


Results Point of Contact:  
Name/Title: Monica Bhatia, MD
Organization: Columbia University Medical Center
phone: 2123055808
e-mail: mb2476@cumc.columbia.edu



Responsible Party: Columbia University
ClinicalTrials.gov Identifier: NCT01010867     History of Changes
Other Study ID Numbers: AAAE0846
First Submitted: November 6, 2009
First Posted: November 10, 2009
Results First Submitted: November 9, 2015
Results First Posted: July 13, 2017
Last Update Posted: July 13, 2017