Lactobacillus Kefiri LKF01 (DSM32079) in Newborns Born by Caesarian Section
NCT ID: NCT03154866
Last Updated: 2017-05-18
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE4
60 participants
INTERVENTIONAL
2017-06-01
2018-06-30
Brief Summary
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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.
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
QUADRUPLE
Study Groups
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Lactobacillus kefiri LKF01 DSM32079
Lactobacillus kefiri LKF01 DSM32079
Lactobacillus kefiri LKF01 DSM32079 in drop formulation. 5 drop/daily for 21 days
Placebo
Placebo
Placebo in drop formulation. 5 drop/daily for 21 days
Interventions
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Lactobacillus kefiri LKF01 DSM32079
Lactobacillus kefiri LKF01 DSM32079 in drop formulation. 5 drop/daily for 21 days
Placebo
Placebo in drop formulation. 5 drop/daily for 21 days
Eligibility Criteria
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Inclusion Criteria
* Adeguate for gestational age
* Born by elective cesarean section
* Otherwise healthy newborn
Exclusion Criteria
* use of probiotics/antibiotics
* gastrointestinal malformation, cystic fibrosis, other genetic diseases
* concurrent participation in other clinical trials
1 Hour
4 Months
ALL
Yes
Sponsors
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Policlinico Hospital
OTHER
Responsible Party
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Prof. Maria Elisabetta Baldassarre
Principal Investigator
Locations
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Dept Of Obstetrics and Neonatology - Section of Neonatology University of Bari Policlinico Hospital
Bari, , Italy
Countries
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Other Identifiers
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KEFINEO1
Identifier Type: -
Identifier Source: org_study_id
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