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

Study Overview
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Brief Summary
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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.

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

Conditions
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Caesarean Section;Stillbirth, Microbial Colonization

Intervention / Treatment
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* Dietary Supplement: Lactobacillus kefiri LKF01 DSM32079
* Dietary Supplement: Placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Term newborn Adeguate for gestational age Born by elective cesarean section Otherwise healthy newborn Exclusion Criteria: major acute or chronic disease use of probiotics/antibiotics gastrointestinal malformation, cystic fibrosis, other genetic diseases concurrent participation in other clinical trials

Ages Eligible for Study
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Minimum Age: 1 Hour
Maximum Age: 4 Months

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Lactobacillus kefiri LKF01 DSM32079<br> | Dietary Supplement: Lactobacillus kefiri LKF01 DSM32079<br>* Lactobacillus kefiri LKF01 DSM32079 in drop formulation. 5 drop/daily for 21 days<br>|
| Placebo Comparator: Placebo<br> | Dietary Supplement: Placebo<br>* Placebo in drop formulation. 5 drop/daily for 21 days<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Presence of Lactobacillus kefiri LKF01 DSM32079 (LKEF) in fecal sample | To evaluate the ability of Lactobacillus kefiri LKF01 DSM32079 (LKEF) to colonize the intestinal environment of newborns born by caesarian section and modify the gut microbiota composition by using a Next Generation Sequencing technology. Presence of Lactobacillus kefiri LKF01 DSM32079 (LKEF) in fecal sample. | 21 days after supplementation start | 
| Number of participants with treatment-related adverse event | A structured diary on possible treatment-related adverse event will be given to mothers. | During 21 days after supplementation | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Lactobacillus kefiri LKF01 DSM32079, Microbial Colonization