Clinical Trial Details
— Status: Completed
Administrative data
| NCT number |
NCT03657485 |
| Other study ID # |
KBET/46/B/2014 |
| Secondary ID |
|
| Status |
Completed |
| Phase |
N/A
|
| First received |
|
| Last updated |
|
| Start date |
April 2014 |
| Est. completion date |
April 2017 |
Study information
| Verified date |
August 2018 |
| Source |
Jagiellonian University |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical Trial 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.
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)
