NCT03834415

Lactobacillus Reuteri DSM17938 in C-Section Infants

Influence of Lactobacillus Reuteri DSM17938 on Early Gut Microbial Colonization in Infants Born by Caesarean Section: A Double-blinded, Randomized, Placebo-controlled Study

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 69 (actual)
• Sponsor: Innovacion y Desarrollo de Estrategias en Salud · Academic / Other
• Sex: All
• Age: 12 Hours – 36 Hours
• Healthy volunteers: Not accepted

Summary

RCT designed to evaluate the impact of Lactobacillus reuteri DSM17938 to modify gut microbiota in children delivered by C-section

Detailed description

RCT designed to evaluate the safety and efficacy of L. reuteri DSM17938 administrated to newborns babies to modify the fecal microbiome after 30 days of supplementation. Secondary Secondary endpoints will be evaluate the occurrence and frequency of AEs Day 0 to Day 60; The gut bacterial composition Day 7 and Day 30 as described in primary endpoint; the gut bacterial composition in infants born by c-section and supplemented with L. reuteri DSM17938 compared to the gut bacterial composition in infants born vaginally and the salivary concentration of IgA at 48h ±3h after birth and at Day 30.

Conditions

• C-section

Interventions

Type	Name	Description
DIETARY_SUPPLEMENT	Lactobacillus reuteri DSM17038	Oil drops of L. reuteri containing 1x10\>8 CFU
OTHER	Placebo for Probiotics	Oil drops mimicking in consistency and flavor to experimental product

Timeline

• Start date: 2019-02-08
• Primary completion: 2019-04-18
• Completion: 2019-06-18
• First posted: 2019-02-08
• Last updated: 2019-06-20

Locations

1 site across 1 country: Mexico