Probiotic Supplementation in the Term Newborns Delivered by Caesarean Section

NCT03657485 | Completed

• 1 other identifier: KBET/46/B/2014
• Study Type: interventional
• Target: 150
• Locations: 0 countries
• Sites: N/A

Brief Summary

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.

Conditions

Microbiota, Cesarean Section, Probiotics, Dysbiosis

Outcome Measures

Primary Outcomes (1)

• microbiota colonization

  Stool microbiotic composition

  1 month of life

Secondary Outcomes (1)

• respiratory infection, gastrointestinal infection

  1 year of life

Other Outcomes (1)

• allergy, atopy

  1 year of life

Study Arms (3)

interventional

EXPERIMENTAL

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

control

NO INTERVENTION

No intervention. Feeding with mother milk

comperative

NO INTERVENTION

Comparing stool composition of vaginally born newborns

Interventions

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).

Also known as: FFBaby

interventional

Eligibility Criteria

• Age: 1 Hour - 1 Day
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

Sponsors & Collaborators

• Jagiellonian University: lead

MeSH Terms

Conditions

Dysbiosis

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: PhD MD

Model Details: The patients we recruited were randomized into 2 groups- interventional or control group. For comparison we examined the stool samples of 32 healthy newborns delivered vaginally

Study Record Dates

• First Submitted: August 31, 2018
• First Posted: September 5, 2018
• Study Start: April 1, 2014
• Primary Completion: April 1, 2017
• Study Completion: April 1, 2017
• Last Updated: September 5, 2018

Record last verified: 2018-08

Data Sharing

• IPD Sharing: Will not share