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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
Sponsor:
Collaborators:
Johns Hopkins All Children's Hospital
Nemours Children's Clinic
Information provided by (Responsible Party):
Columbia University

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
Enrollment 31
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Lactobacillus Plantarum
Hide Arm/Group Description

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)

Period Title: Overall Study
Started 31
Completed 30
Not Completed 1
Reason Not Completed
< 50% adherence to probiotic             1
Arm/Group Title Lactobacillus Plantarum
Hide Arm/Group Description

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.

Overall Number of Baseline Participants 31
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 31 participants
7.8  (4.7)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 31 participants
Female
14
  45.2%
Male
17
  54.8%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 31 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  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 31 participants
31
1.Primary Outcome
Title Number of Lactobacillus Plantarum Bacteremia Infections
Hide Description [Not Specified]
Time Frame 36 days (day -7 to +28 of HSCT)
Hide Outcome Measure Data
Hide Analysis Population Description
Children and adolescents undergoing hematopoietic stem cell transplantation (HSCT)
Arm/Group Title Lactobacillus Plantarum
Hide Arm/Group Description:

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.

Overall Number of Participants Analyzed 30
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: Number of infections
0
(0 to 12)
2.Secondary Outcome
Title Adherence With the Prescribed Dose, Measured as the Percentage of Prescribed Probiotic Doses
Hide Description 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).
Time Frame 22 days (day -7 to +14 of HSCT)
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Lactobacillus Plantarum
Hide Arm/Group Description:

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.

Overall Number of Participants Analyzed 30
Median (Full Range)
Unit of Measure: percentage of prescribed doses
97
(50 to 100)
3.Secondary Outcome
Title Number of Non-lactobacillus Infections
Hide Description To determine incidence of bacteremia in HSCT patients who have been administered lactobacillus plantarum.
Time Frame 36 days (day -7 to +28 of HSCT)
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Lactobacillus Plantarum
Hide Arm/Group Description:

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.

Overall Number of Participants Analyzed 30
Measure Type: Number
Unit of Measure: Number of non-lactobacillus infections
6
4.Secondary Outcome
Title Number of Acute Graft Versus Host Disease (GVHD) Events in HSCT Patients Who Have Been Administered Lactobacillus Plantarum
Hide Description [Not Specified]
Time Frame Up to Day +100 of HSCT
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Lactobacillus Plantarum
Hide Arm/Group Description:

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.

Overall Number of Participants Analyzed 30
Measure Type: Number
Unit of Measure: Number of GVHD events
9
Time Frame Adverse event data were collected and reported up to Day +100
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Lactobacillus Plantarum
Hide Arm/Group Description

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.

All-Cause Mortality
Lactobacillus Plantarum
Affected / at Risk (%)
Total   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Lactobacillus Plantarum
Affected / at Risk (%)
Total   0/30 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 1%
Lactobacillus Plantarum
Affected / at Risk (%)
Total   0/30 (0.00%) 
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Monica Bhatia, MD
Organization: Columbia University Medical Center
Phone: 2123055808
EMail: mb2476@cumc.columbia.edu
Layout table for additonal information
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