Safety of Lactobacillus reuteri DSM 17938 in Healthy Children 2 to 5 Years of Age.
- 2019-08
- Pediatric Infectious Disease Journal 38(8)
- M. Kosek
- Pablo Peñataro-Yori
- Maribel Paredes-Olórtegui
- J. Lefante
- César Ramal-Asayag
- Marcelo Zamora-Babilonia
- Graciela Meza-Sánchez
- R. Oberhelman
- PubMed: 30531312
- DOI: 10.1097/INF.0000000000002267
Study Design
- Type
- Randomized Controlled Trial (RCT)
- Sample size
- n = 60
- Population
- Children aged 2-5 years in Peru
- Methods
- Phase-one placebo-controlled study
Abstract
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.
Trial registration: ClinicalTrials.gov NCT02124122.
Research Insights
No differences in objective data on adverse events were noted
- Effect
- Neutral
- Effect size
- Small
some differences based on subjective parental reports for fever and diarrhea were seen
- Effect
- Neutral
- Effect size
- Small
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
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