Clinical Trial Details
— Status: Completed
Administrative data
NCT number |
NCT05005286 |
Other study ID # |
USM/JEPeM/20090500 |
Secondary ID |
|
Status |
Completed |
Phase |
|
First received |
|
Last updated |
|
Start date |
December 1, 2020 |
Est. completion date |
November 30, 2021 |
Study information
Verified date |
March 2022 |
Source |
Universiti Sains Malaysia |
Contact |
n/a |
Is FDA regulated |
No |
Health authority |
|
Study type |
Observational
|
Clinical Trial Summary
The aim of this study is to evaluate the difference of breast milk microbiota between mothers
with and without vaginal infections during pregnancy.
Description:
The maternal microbiota is one of the relevant factors in the development of the infant's
immune system, whereby the colonization of microbes in human begins at birth, when the
newborn baby is exposed to maternal vaginal, gastrointestinal microbiota and as well as the
microbes from the external environment. The neonatal intestine is colonized by symbiotic
bacteria can be divided into four main steps; (i) acquisition of maternal vaginal, colonic,
and skin flora at birth; (ii) introduction of oral feedings (breastfeeding or formula
feeding); (iii) weaning; and (iv) acquisition of complete adult colonization.
Breastfeeding is associated with the protection of the infants from either infections or
infection-related conditions, such as gastroenteritis, upper and lower respiratory tract
infection, acute otitis media, urinary tract infection, neonatal septicaemia and necrotizing
enterocoltis. The protection is through the combination of action of the breast milk
components, such as maternal immunoglobulins, immunocompetent cells, or variety of
anti-microbial compounds. Besides that, breast milk also contains prebiotic substances which
may selectively stimulate the growth of limited number of beneficial bacteria in the gut.
A total number of 100 lactating mothers are needed for this study. Subjects will be recruited
from HUSM Kubang Kerian, USM Main Campus Penang, and Institut Perubatan & Pergigian Termaju
USM Penang. The subjects will be explained on all related information in the consent form
prior to signing. The procedure of collecting sample is hands must be washed before milk
expression, and nipples are cleaned with sterile water and alcohol swab. 15mL of fresh breast
milk will be collected into a tube and stored at -20℃ until further analyses.