Trial Outcomes & Findings for Safety of Lactobacillus Reuteri in Healthy Children Aged 2-24 Months (NCT NCT02460575)

NCT ID: NCT02460575

Last Updated: 2020-05-04

Results Overview

number of participants with positive blood culture for L. reuteri

• Recruitment status: COMPLETED
• Study phase: PHASE1
• Target enrollment: 60 participants
• Primary outcome timeframe: Participants are followed for an average of 36 days
• Results posted on: 2020-05-04

Participant Flow

Participant milestones

Measure	Lactobacillus Active Product: Description Lactobacillus reuteri 17938 suspended in sunflower oil, medium chain triglyceride oil, silicone dioxide. Total viable count of L. reuteri 17938 1 x 108 CFU/5 drops. Lactobacillus reuteri 17938: probiotic	Placebo Composition Sunflower oil, medium chain triglyceride oil and silicon dioxide. Total viable count of L. reuteri is zero CFU/ 5 drops. Placebo: Composition Sunflower oil, medium chain triglyceride oil and silicon dioxide. Total viable count of L. reuteri is zero CFU/ 5 drops.
Overall Study STARTED	40	20
Overall Study COMPLETED	39	20
Overall Study NOT COMPLETED	1	0

Reasons for withdrawal

Measure	Lactobacillus Active Product: Description Lactobacillus reuteri 17938 suspended in sunflower oil, medium chain triglyceride oil, silicone dioxide. Total viable count of L. reuteri 17938 1 x 108 CFU/5 drops. Lactobacillus reuteri 17938: probiotic	Placebo Composition Sunflower oil, medium chain triglyceride oil and silicon dioxide. Total viable count of L. reuteri is zero CFU/ 5 drops. Placebo: Composition Sunflower oil, medium chain triglyceride oil and silicon dioxide. Total viable count of L. reuteri is zero CFU/ 5 drops.
Overall Study Lost to Follow-up	1	0

Baseline Characteristics

Safety of Lactobacillus Reuteri in Healthy Children Aged 2-24 Months

Baseline characteristics by cohort

Measure	Lactobacillus n=40 Participants Active Product: Description Lactobacillus reuteri 17938 suspended in sunflower oil, medium chain triglyceride oil, silicone dioxide. Total viable count of L. reuteri 17938 1 x 108 CFU/5 drops. Lactobacillus reuteri 17938: probiotic	Placebo n=20 Participants Composition Sunflower oil, medium chain triglyceride oil and silicon dioxide. Total viable count of L. reuteri is zero CFU/ 5 drops. Placebo: Composition Sunflower oil, medium chain triglyceride oil and silicon dioxide. Total viable count of L. reuteri is zero CFU/ 5 drops.	Total n=60 Participants Total of all reporting groups
Age, Categorical <=18 years	40 Participants n=5 Participants	20 Participants n=7 Participants	60 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Continuous	10.5 months STANDARD_DEVIATION 5.8 • n=5 Participants	11.9 months STANDARD_DEVIATION 5.2 • n=7 Participants	10.9 months STANDARD_DEVIATION 5.6 • n=5 Participants
Sex: Female, Male Female	17 Participants n=5 Participants	12 Participants n=7 Participants	29 Participants n=5 Participants
Sex: Female, Male Male	23 Participants n=5 Participants	8 Participants n=7 Participants	31 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	40 Participants n=5 Participants	20 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	40 participants n=5 Participants	20 participants n=7 Participants	60 participants n=5 Participants

PRIMARY outcome

Timeframe: Participants are followed for an average of 36 days

number of participants with positive blood culture for L. reuteri

Outcome measures

Measure	Lactobacillus n=40 Participants Active Product: Description Lactobacillus reuteri 17938 suspended in sunflower oil, medium chain triglyceride oil, silicone dioxide. Total viable count of L. reuteri 17938 1 x 108 CFU/5 drops. Lactobacillus reuteri 17938: probiotic	Placebo n=20 Participants Composition Sunflower oil, medium chain triglyceride oil and silicon dioxide. Total viable count of L. reuteri is zero CFU/ 5 drops. Placebo: Composition Sunflower oil, medium chain triglyceride oil and silicon dioxide. Total viable count of L. reuteri is zero CFU/ 5 drops.
Number of Participants With Positive Blood Culture for L. Reuteri	0 Participants	0 Participants

PRIMARY outcome

Timeframe: 5 days of study product administration

Outcome measures

Measure	Lactobacillus n=40 Participants Active Product: Description Lactobacillus reuteri 17938 suspended in sunflower oil, medium chain triglyceride oil, silicone dioxide. Total viable count of L. reuteri 17938 1 x 108 CFU/5 drops. Lactobacillus reuteri 17938: probiotic	Placebo n=20 Participants Composition Sunflower oil, medium chain triglyceride oil and silicon dioxide. Total viable count of L. reuteri is zero CFU/ 5 drops. Placebo: Composition Sunflower oil, medium chain triglyceride oil and silicon dioxide. Total viable count of L. reuteri is zero CFU/ 5 drops.
Mean Daily Temperature	36.5 degrees Centigrade/day Standard Deviation 0.23	36.5 degrees Centigrade/day Standard Deviation 0.23

Adverse Events

Lactobacillus

Serious events: 0 serious events

Other events: 28 other events

Deaths: 0 deaths

Placebo

Serious events: 0 serious events

Other events: 16 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Measure	Lactobacillus n=40 participants at risk Active Product: Description Lactobacillus reuteri 17938 suspended in sunflower oil, medium chain triglyceride oil, silicone dioxide. Total viable count of L. reuteri 17938 1 x 108 CFU/5 drops. Lactobacillus reuteri 17938: probiotic	Placebo n=20 participants at risk Composition Sunflower oil, medium chain triglyceride oil and silicon dioxide. Total viable count of L. reuteri is zero CFU/ 5 drops. Placebo: Composition Sunflower oil, medium chain triglyceride oil and silicon dioxide. Total viable count of L. reuteri is zero CFU/ 5 drops.
General disorders All	70.0% 28/40 • Number of events 43 • 3 month followup period same as clinicaltrials.gov definition	80.0% 16/20 • Number of events 27 • 3 month followup period same as clinicaltrials.gov definition
General disorders Fever	42.5% 17/40 • Number of events 17 • 3 month followup period same as clinicaltrials.gov definition	45.0% 9/20 • Number of events 9 • 3 month followup period same as clinicaltrials.gov definition
Gastrointestinal disorders Diarrhea	32.5% 13/40 • Number of events 13 • 3 month followup period same as clinicaltrials.gov definition	35.0% 7/20 • Number of events 7 • 3 month followup period same as clinicaltrials.gov definition
Gastrointestinal disorders Vomiting	5.0% 2/40 • Number of events 2 • 3 month followup period same as clinicaltrials.gov definition	5.0% 1/20 • Number of events 1 • 3 month followup period same as clinicaltrials.gov definition
General disorders Irritability	5.0% 2/40 • Number of events 2 • 3 month followup period same as clinicaltrials.gov definition	0.00% 0/20 • 3 month followup period same as clinicaltrials.gov definition
Skin and subcutaneous tissue disorders Rash	2.5% 1/40 • Number of events 1 • 3 month followup period same as clinicaltrials.gov definition	5.0% 1/20 • Number of events 1 • 3 month followup period same as clinicaltrials.gov definition
General disorders Pruritis	2.5% 1/40 • Number of events 1 • 3 month followup period same as clinicaltrials.gov definition	5.0% 1/20 • Number of events 1 • 3 month followup period same as clinicaltrials.gov definition
Respiratory, thoracic and mediastinal disorders Wheezing	10.0% 4/40 • Number of events 4 • 3 month followup period same as clinicaltrials.gov definition	35.0% 7/20 • Number of events 7 • 3 month followup period same as clinicaltrials.gov definition

Additional Information

Dr. Richard Oberhelman

Tulane University

Phone: 504-988-2511

Email: oberhel@tulane.edu

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place