NCT03154866

Lactobacillus Kefiri LKF01 (DSM32079) in Newborns Born by Caesarian Section

Ability of Lactobacillus Kefiri LKF01 (DSM32079) to Colonize the Intestinal Environment and Modify the Gut Microbiota Composition of Newborns Born by Caesarian Section

• Status: Unknown
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 60 (estimated)
• Sponsor: Policlinico Hospital · Academic / Other
• Sex: All
• Age: 1 Hour – 4 Months
• Healthy volunteers: Accepted

Summary

The mode of delivery affects the diversity and colonization pattern of the gut microbiota during the first year of infants' life. Probiotics have been observed to positively influence the host's health, but to date few data about the ability of probiotics to modify the gut microbiota composition exist. 40 newborns born by elective caesarian sectional be randomized to a Lactobacillus kefiri LKF01 DSM32079 (LKEF) supplementation or placebo for 21 days. Changes in the gut microbiota composition were detected by using a Next Generation Sequencing technology.

Conditions

• Caesarean Section;Stillbirth
• Microbial Colonization

Interventions

Type	Name	Description
DIETARY_SUPPLEMENT	Lactobacillus kefiri LKF01 DSM32079	Lactobacillus kefiri LKF01 DSM32079 in drop formulation. 5 drop/daily for 21 days
DIETARY_SUPPLEMENT	Placebo	Placebo in drop formulation. 5 drop/daily for 21 days

Timeline

• Start date: 2017-06-01
• Primary completion: 2017-12-31
• Completion: 2018-06-30
• First posted: 2017-05-16
• Last updated: 2017-05-18

Locations

1 site across 1 country: Italy