Skip to main content
OpenTrials
Completed

NCT Number: NCT03657485

Probiotic Supplementation in the Term Newborns Delivered by Caesarean Section

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Microbiota, Cesarean Section, Probiotics, Dysbiosis Dysbiosis Pathologic Processes Pathological Conditions, Signs and Symptoms

Age range

1 hour–1 day

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

About this study

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)

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

-

Exclusion criteria

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

-

Treatment and study plan

containing Bifidobacterium breve PB04, Lactobacillus rhamnosus KL53A

Dietary Supplement

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

Primary outcomes

  1. microbiota colonization

    Time frame: 1 month of life

    Stool microbiotic composition

Secondary outcomes

  1. respiratory infection, gastrointestinal infection

    Time frame: 1 year of life

    frequency of respiratory and gastrointestinal infection

Other outcomes

  1. allergy, atopy

    Time frame: 1 year of life

    allergy or atopy episodes

Sponsors and collaborators

Lead sponsor

Jagiellonian University

Other

Registry information

Official study title

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

Important dates

Study start
2014
Primary completion
2017
Study completion
2017
First posted
Sep 5, 2018
Registry last updated
Sep 5, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.