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

NCT03154866 · Status: UNKNOWN · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 60

Last updated 2017-05-18

No results posted yet for this study

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

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

Sponsors & Collaborators

  • Policlinico Hospital

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
1 Hour
Max Age
4 Months
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2017-06-01
Primary Completion
2017-12-31
Completion
2018-06-30

Countries

  • Italy

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03154866 on ClinicalTrials.gov