Safety of Lactobacillus Reuteri DSM 17938 in Healthy Children 2-5 Years of Age.
- 2019-08
- The Pediatric infectious disease journal 38(8)
- Margaret N Kosek
- Pablo Peñataro-Yori
- Maribel Paredes-Olortegui
- John Lefante
- Cesar Ramal-Asayag
- Marcelo Zamora-Babilonia
- Graciela Meza-Sanchez
- Richard A Oberhelman
- PubMed: 30531312
- DOI: 10.1097/inf.0000000000002267
Study Design
- Type
- Randomized Controlled Trial (RCT)
- Sample size
- n = 60
- Population
- 60 children 2-5 years of age (41 L. reuteri, 19 placebos) in a resource-constrained community in Peru
- Methods
- phase-one placebo-controlled study of Lactobacillus reuteri DSM 17938 under Investigational New Drug program
- Blinding
- Double-blind
Probiotics are increasingly used for diarrhea, but studies under the Food and Drug Administration and Investigational New Drug program are few. We conducted a phase-one placebo-controlled study of Lactobacillus reuteri DSM 17938 under Investigational New Drug program in 60 children 2-5 years of age (41 L. reuteri, 19 placebos) in a resource-constrained community in Peru. No differences in objective data on adverse events were noted, although some differences based on subjective parental reports for fever and diarrhea were seen.
Research Insights
although some differences based on subjective parental reports for fever and diarrhea were seen
- Effect
- Neutral
- Effect size
- Small
although some differences based on subjective parental reports for fever and diarrhea were seen
- Effect
- Neutral
- Effect size
- Small
Adverse Events Reported
No differences in objective data on adverse events were noted
- Finding
- No significant difference
- Significant
- No
some differences based on subjective parental reports for fever and diarrhea were seen
- Finding
- Reported
some differences based on subjective parental reports for fever and diarrhea were seen
- Finding
- Reported