Healthy
Conditions
Keywords
Focus, safety
Brief summary
This is a Phase 1 study to assess the safety and tolerability of Lactobacillus reuteri (Lr) strain DSM 17938 in healthy children in Peru. It is a preliminary study in support of a clinical trial to assess safety and efficacy of L. reuteri for treatment of pediatric diarrhea in Peru.
Detailed description
This is a phase I blinded randomized study of the safety and tolerability of Lactobacillus reuteri DSM 17938 given daily for a period of five consecutive days. Upon enrollment subjects will be randomized to one of two treatment groups in a ratio of treatment to placebo of 2:1. Subjects will be randomized to receive either: A. 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). B. 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). In the first 30 subjects randomized, administration of each dose of the study preparation drops (A or B above) will be immediately followed by offering 2 ounces of flavored PediaSure ® (Abbott Laboratories) nutritional supplement to each child. The second 30 subjects enrolled will not be offered PediaSure ® after product administration. This format will also allow us to assess the impact of concurrent administration of a buffering non-lactose containing formula with prebiotic nutritional properties on intestinal colonization with L. reuteri by PCR.
Interventions
BIOLOGICALLactobacillus reuteri
Probiotic
BIOLOGICALPlacebo
Placebo
Sponsors
National Center for Complementary and Integrative Health (NCCIH)
Johns Hopkins Bloomberg School of Public Health
Asociacion Benefica Prisma
Tulane University School of Medicine
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Investigator)
Eligibility
Sex/Gender
ALL
Age
2 Years to 5 Years
Healthy volunteers
Yes
Inclusion criteria
* Children ages 2-5 years with no
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With Positive Blood Culture for L Reuteri | Participants are followed an average of 36 days | — |
| Mean Daily Temperature | Study days 1-5, 8,12, 15, 18, 28, and 36 | Mean of body temperatures recorded on study days listed, averaged across all participants at all time points |
Countries
Peru
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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 | 41 |
| 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 | 19 |
| Total | 60 |
Baseline characteristics
| Characteristic | Lactobacillus | Placebo | Total |
|---|---|---|---|
| Age, Continuous | 4.04 years STANDARD_DEVIATION 1.278 | 3.31 years STANDARD_DEVIATION 1.08 | 3.81 years STANDARD_DEVIATION 1.258 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 41 Participants | 19 Participants | 60 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 0 Participants | 0 Participants | 0 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Region of Enrollment Peru | 41 participants | 19 participants | 60 participants |
| Sex: Female, Male Female | 21 Participants | 13 Participants | 34 Participants |
| Sex: Female, Male Male | 20 Participants | 6 Participants | 26 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 25 / 41 | 18 / 19 |
| serious Total, serious adverse events | 0 / 41 | 0 / 19 |
Outcome results
Primary
Mean Daily Temperature
Mean of body temperatures recorded on study days listed, averaged across all participants at all time points
Time frame: Study days 1-5, 8,12, 15, 18, 28, and 36
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Lactobacillus | Mean Daily Temperature | 36.50 Degrees Celsius | Standard Deviation 0.288 |
| Placebo | Mean Daily Temperature | 36.45 Degrees Celsius | Standard Deviation 0.232 |
Primary
Number of Participants With Positive Blood Culture for L Reuteri
Time frame: Participants are followed an average of 36 days
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Lactobacillus | Number of Participants With Positive Blood Culture for L Reuteri | 0 Participants |
| Placebo | Number of Participants With Positive Blood Culture for L Reuteri | 0 Participants |