Probiotic Supplementation in the Term Newborns Delivered by Caesarean Section

Probiotic Supplementation in the Term Newborns Delivered by Caesarean Section: a Randomized, Prospective Clinical Trials

Objectives: The gut microbiota plays pivotal role in the maintenance of human health. There are numerous factors, including the mode of delivery, that impact early gut colonization. Recent research focuses on probiotics' use in prophylaxy of gut dysbiosis in the newborns delivered by CS. We aimed to investigate whether a probiotic supplement in the newborns delivered by CS alter the pattern of gut colonization and has effect on decreasing risk of dysbiosis.

Methods: a prospective, randomized trial with a control group. 150 newborns, born in 38-40 gestational age, delivered by CS were included to the study. They were randomized into 2 groups- interventional supplemented with the probiotic containing Bifidobacterium breve PB04 i Lactobacillus rhamnosus KL53A (FFBaby, IBSS BioMed SA, Poland) and control. Stool samples were obtained on 5th and 6th day of life and after one month of life, and analyzed microbiologically in the lab. Bacterial colonies' genre and species were next identified and quantified.

Study Overview

• Status: Completed
• Conditions: Microbiota, Cesarean Section, Probiotics, Dysbiosis
• Intervention / Treatment: Dietary supplement: containing Bifidobacterium breve PB04, Lactobacillus rhamnosus KL53A

Detailed Description

The aim of the study was to assess the effect of the probiotic supplementation on microbiota composition of the gut in healthy newborns delivered by CS. We studied colonization of GI tract on the day of discharge from hospital and after a month of life.

It was a prospective, randomized trial with the control group, conducted in the Neonatal Clinic of the Jagiellonian University Hospital in Kraków, lasting from April 2014 to April 2017.

The patients we recruited were randomized into 2 groups- interventional or control group. In the interventional group we supplemented the probiotic containing Bifidobacterium breve PB04 i Lactobacillus rhamnosus KL53A (FFBaby, IBSS BioMed SA, Poland) orally during the first hour of life and after 12 hours in mother's milk or formula (the total amount of the probiotic was 2 x 10 6 CFU bacteria).

The permission for the clinical trial was granted by the regional medical Bioethical Committee of the Jagiellonian University. (The number of decision- KBET/46/B/2014 from the 27th of March 2014)

• Study Type: Interventional
• Enrollment (Actual): 150
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 1 year to 1 year (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:38-40 gestational age, normal, healthy pregnancy, delivery by CS, good clinical condition after birth, Apgar scale- 8-10 points, proper gestational mass> 2500g, informed consent of parents.

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Exclusion Criteria:conditions mentioned above were not fulfilled, lack of informed consent of the parents or their resignation from the study.

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Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: interventional; In the interventional group we supplemented the probiotic containing Bifidobacterium breve PB04 i Lactobacillus rhamnosus KL53A (FFbaby, IBSS Biomed SA, Poland) orally during the first hour of life and after 12 hours in mother's milk or formula (the total amount of the probiotic was 2 x 10 6 CFU bacteria).	Dietary supplement: containing Bifidobacterium breve PB04, Lactobacillus rhamnosus KL53A; we supplemented the probiotic orally during the first hour of life and after 12 hours in mother's milk or formula (the total amount of the probiotic was 2 x 10 6 CFU bacteria).; Other Names: FFBaby
No Intervention: control; No intervention. Feeding with mother milk
No Intervention: comperative; Comparing stool composition of vaginally born newborns

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
microbiota colonization	Stool microbiotic composition	1 month of life

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
respiratory infection, gastrointestinal infection	frequency of respiratory and gastrointestinal infection	1 year of life

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
allergy, atopy	allergy or atopy episodes	1 year of life

Collaborators and Investigators

• Sponsor: Jagiellonian University

Study record dates

Study Major Dates

• Study Start (Actual): April 1, 2014
• Primary Completion (Actual): April 1, 2017
• Study Completion (Actual): April 1, 2017

Study Registration Dates

• First Submitted: August 31, 2018
• First Submitted That Met QC Criteria: September 4, 2018
• First Posted (Actual): September 5, 2018

Study Record Updates

• Last Update Posted (Actual): September 5, 2018
• Last Update Submitted That Met QC Criteria: September 4, 2018
• Last Verified: August 1, 2018

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Dysbiosis
• Other Study ID Numbers: KBET/46/B/2014

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No
• IPD Plan Description: participant data available for study statistics and laboratory stuff

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No