drugset / Trial / NCT02460575
Safety of Lactobacillus Reuteri in Healthy Children Aged 2-24 Months
Phase 1
Completed
60 enrolled
Tulane University School of Medicine
Asociacion Benefica Prisma · collabJohns Hopkins Bloomberg School of Public Health · collabNational Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) · collabUniversity of Virginia · collab
RandomizedParallel-groupQuadruple-blindTreatment
Summary
Phase I double blinded randomized trial of the safety and tolerability of Lactobacillus reuteri DSM 17938 given for five successive days in healthy children. Sixty children will receive study product at a treatment to placebo ratio of 2:1 and followed for 3 months for safety outcomes.
Timeline
- Start
- 2019-01-09
- Primary completion
- 2019-12-29
- Completion
- 2019-12-29
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Lactobacillus reuteri 17938 | Other / unclassified | 1e+08 unknown | — |
Indications
No indication recorded.