Trial Outcomes & Findings for Safety of Lactobacillus Reuteri in Healthy Children Ages 2 to 5 Years in Peru (NCT NCT02124122)
NCT ID: NCT02124122
Last Updated: 2017-04-24
Results Overview
Recruitment status
COMPLETED
Study phase
PHASE1
Target enrollment
60 participants
Primary outcome timeframe
Participants are followed an average of 36 days
Results posted on
2017-04-24
Participant Flow
Participant milestones
| Measure |
Lactobacillus
Lactobacillus reuteri (Lr): 108 (100 million) organisms of Lactobacillus reuteri per dose, given once daily for a five-day treatment period that corresponds to a dose of the closely related L. reuteri ATCC 55730 strain that has shown to be therapeutic for infantile colic. The strain used in this study (DSM 17938) has been cured of an antibiotic resistance plasmid found in the original BioGaia strain (L. reuteri ATCC 55730).
Lactobacillus reuteri: Probiotic
|
Placebo
Placebo oil preparation, administered as 5 drops of the oil vehicle used in manufacturing the Lr suspension, given once daily for a five-day study period (BioGaia AB, Stockholm, Sweden).
Placebo: Placebo
|
|---|---|---|
|
Overall Study
STARTED
|
41
|
19
|
|
Overall Study
COMPLETED
|
41
|
19
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Safety of Lactobacillus Reuteri in Healthy Children Ages 2 to 5 Years in Peru
Baseline characteristics by cohort
| Measure |
Lactobacillus
n=41 Participants
Lactobacillus reuteri (Lr): 108 (100 million) organisms of Lactobacillus reuteri per dose, given once daily for a five-day treatment period that corresponds to a dose of the closely related L. reuteri ATCC 55730 strain that has shown to be therapeutic for infantile colic. The strain used in this study (DSM 17938) has been cured of an antibiotic resistance plasmid found in the original BioGaia strain (L. reuteri ATCC 55730).
Lactobacillus reuteri: Probiotic
|
Placebo
n=19 Participants
Placebo oil preparation, administered as 5 drops of the oil vehicle used in manufacturing the Lr suspension, given once daily for a five-day study period (BioGaia AB, Stockholm, Sweden).
Placebo: Placebo
|
Total
n=60 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
4.04 years
STANDARD_DEVIATION 1.278 • n=5 Participants
|
3.31 years
STANDARD_DEVIATION 1.080 • n=7 Participants
|
3.81 years
STANDARD_DEVIATION 1.258 • n=5 Participants
|
|
Sex: Female, Male
Female
|
21 Participants
n=5 Participants
|
13 Participants
n=7 Participants
|
34 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
20 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
26 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
41 Participants
n=5 Participants
|
19 Participants
n=7 Participants
|
60 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
Peru
|
41 participants
n=5 Participants
|
19 participants
n=7 Participants
|
60 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Participants are followed an average of 36 daysOutcome measures
| Measure |
Lactobacillus
n=41 Participants
Lactobacillus reuteri (Lr): 108 (100 million) organisms of Lactobacillus reuteri per dose, given once daily for a five-day treatment period that corresponds to a dose of the closely related L. reuteri ATCC 55730 strain that has shown to be therapeutic for infantile colic. The strain used in this study (DSM 17938) has been cured of an antibiotic resistance plasmid found in the original BioGaia strain (L. reuteri ATCC 55730).
Lactobacillus reuteri: Probiotic
|
Placebo
n=19 Participants
Placebo oil preparation, administered as 5 drops of the oil vehicle used in manufacturing the Lr suspension, given once daily for a five-day study period (BioGaia AB, Stockholm, Sweden).
Placebo: Placebo
|
|---|---|---|
|
Number of Participants With Positive Blood Culture for L Reuteri
|
0 Participants
|
0 Participants
|
PRIMARY outcome
Timeframe: Study days 1-5, 8,12, 15, 18, 28, and 36Mean of body temperatures recorded on study days listed, averaged across all participants at all time points
Outcome measures
| Measure |
Lactobacillus
n=41 Participants
Lactobacillus reuteri (Lr): 108 (100 million) organisms of Lactobacillus reuteri per dose, given once daily for a five-day treatment period that corresponds to a dose of the closely related L. reuteri ATCC 55730 strain that has shown to be therapeutic for infantile colic. The strain used in this study (DSM 17938) has been cured of an antibiotic resistance plasmid found in the original BioGaia strain (L. reuteri ATCC 55730).
Lactobacillus reuteri: Probiotic
|
Placebo
n=19 Participants
Placebo oil preparation, administered as 5 drops of the oil vehicle used in manufacturing the Lr suspension, given once daily for a five-day study period (BioGaia AB, Stockholm, Sweden).
Placebo: Placebo
|
|---|---|---|
|
Mean Daily Temperature
|
36.50 Degrees Celsius
Standard Deviation 0.288
|
36.45 Degrees Celsius
Standard Deviation 0.232
|
Adverse Events
Lactobacillus
Serious events: 0 serious events
Other events: 25 other events
Deaths: 0 deaths
Placebo
Serious events: 0 serious events
Other events: 18 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Lactobacillus
n=41 participants at risk
Lactobacillus reuteri (Lr): 108 (100 million) organisms of Lactobacillus reuteri per dose, given once daily for a five-day treatment period that corresponds to a dose of the closely related L. reuteri ATCC 55730 strain that has shown to be therapeutic for infantile colic. The strain used in this study (DSM 17938) has been cured of an antibiotic resistance plasmid found in the original BioGaia strain (L. reuteri ATCC 55730).
Lactobacillus reuteri: Probiotic
|
Placebo
n=19 participants at risk
Placebo oil preparation, administered as 5 drops of the oil vehicle used in manufacturing the Lr suspension, given once daily for a five-day study period (BioGaia AB, Stockholm, Sweden).
Placebo: Placebo
|
|---|---|---|
|
Gastrointestinal disorders
Diarrhea
|
9.8%
4/41 • Number of events 6 • Day 0 through Day 28 after day 0
|
36.8%
7/19 • Number of events 7 • Day 0 through Day 28 after day 0
|
|
Respiratory, thoracic and mediastinal disorders
Upper repiratory infection
|
56.1%
23/41 • Number of events 32 • Day 0 through Day 28 after day 0
|
47.4%
9/19 • Number of events 14 • Day 0 through Day 28 after day 0
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonia
|
2.4%
1/41 • Number of events 1 • Day 0 through Day 28 after day 0
|
0.00%
0/19 • Day 0 through Day 28 after day 0
|
|
Renal and urinary disorders
Urinary tract infection
|
7.3%
3/41 • Number of events 3 • Day 0 through Day 28 after day 0
|
10.5%
2/19 • Number of events 2 • Day 0 through Day 28 after day 0
|
|
Skin and subcutaneous tissue disorders
Cellulitis
|
2.4%
1/41 • Number of events 1 • Day 0 through Day 28 after day 0
|
0.00%
0/19 • Day 0 through Day 28 after day 0
|
|
Infections and infestations
Malaria
|
2.4%
1/41 • Number of events 1 • Day 0 through Day 28 after day 0
|
5.3%
1/19 • Number of events 1 • Day 0 through Day 28 after day 0
|
|
Infections and infestations
Scabies
|
0.00%
0/41 • Day 0 through Day 28 after day 0
|
5.3%
1/19 • Number of events 1 • Day 0 through Day 28 after day 0
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place