Trial Outcomes & Findings for Probiotic Use in Children Undergoing Hematopoietic Stem Cell Transplantation (HSCT) (NCT NCT01010867)

NCT ID: NCT01010867

Last Updated: 2017-07-13

Results Overview

Recruitment status

COMPLETED

Study phase

PHASE1

Target enrollment

31 participants

Primary outcome timeframe

36 days (day -7 to +28 of HSCT)

Results posted on

2017-07-13

Participant Flow

Participant milestones

Participant milestones
Measure	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)
Overall Study STARTED	31
Overall Study COMPLETED	30
Overall Study NOT COMPLETED	1

Reasons for withdrawal

Reasons for withdrawal
Measure	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)
Overall Study < 50% adherence to probiotic	1

Baseline Characteristics

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

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Lactobacillus Plantarum n=31 Participants 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.
Age, Continuous	7.8 years STANDARD_DEVIATION 4.7 • n=5 Participants
Sex: Female, Male Female	14 Participants n=5 Participants
Sex: Female, Male Male	17 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants
Race (NIH/OMB) Asian	2 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	12 Participants n=5 Participants
Race (NIH/OMB) White	17 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants
Region of Enrollment United States	31 participants n=5 Participants

PRIMARY outcome

Timeframe: 36 days (day -7 to +28 of HSCT)

Population: Children and adolescents undergoing hematopoietic stem cell transplantation (HSCT)

Outcome measures

Outcome measures
Measure	Lactobacillus Plantarum n=30 Participants 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.
Number of Lactobacillus Plantarum Bacteremia Infections	0 Number of infections Interval 0.0 to 12.0

SECONDARY outcome

Timeframe: 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).

Outcome measures

Outcome measures
Measure	Lactobacillus Plantarum n=30 Participants 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.
Adherence With the Prescribed Dose, Measured as the Percentage of Prescribed Probiotic Doses	97 percentage of prescribed doses Interval 50.0 to 100.0

SECONDARY outcome

Timeframe: 36 days (day -7 to +28 of HSCT)

To determine incidence of bacteremia in HSCT patients who have been administered lactobacillus plantarum.

Outcome measures

Outcome measures
Measure	Lactobacillus Plantarum n=30 Participants 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.
Number of Non-lactobacillus Infections	6 Number of non-lactobacillus infections

SECONDARY outcome

Timeframe: Up to Day +100 of HSCT

Outcome measures

Outcome measures
Measure	Lactobacillus Plantarum n=30 Participants 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.
Number of Acute Graft Versus Host Disease (GVHD) Events in HSCT Patients Who Have Been Administered Lactobacillus Plantarum	9 Number of GVHD events

Adverse Events

Lactobacillus Plantarum

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Monica Bhatia, MD

Columbia University Medical Center

Phone: 2123055808

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place