Clinical trial NCT05005286: Evaluation of Breastmilk Microbiota as a Function for Immunity
Official title: Comparison of Microbiota Composition and Antimicrobial Property From Breastmilk of Mothers With and Without Pregnancy Vaginal Infections
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Vaginal Infection
Breastmilk Collection
Keywords: Breastmilk
Vaginal Infection
Immunity properties
Lead sponsor: Universiti Sains Malaysia
Sponsor class: OTHER
First posted: 2021-08-13
Enrollment: 85
Sex: FEMALE
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Subjects will be recruited from HUSM Kubang Kerian, USM Main Campus Penang, USM Kelantan and Institut Perubatan \& Pergigian Termaju USM.

Brief summary: The aim of this study is to evaluate the difference of breast milk microbiota between mothers with and without vaginal infections during pregnancy.

Detailed 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.

Eligibility criteria: Inclusion Criteria:

* Lactating women
* Willing to commit throughout the experiment

Exclusion Criteria:

* Long term medication due to certain illnesses for over 3 months during pregnancy
* Gestational diabetes during pregnancy
* History of diabetes, coronary heart disease, and hypertension in life
* BMI before pregnancy above 24.9
* Consuming probiotic product during pregnancy
* Consuming probiotic product during lactation period

Primary outcomes:
measure: Breastmilk microbiota profiles
timeFrame: 6 months
Secondary outcomes:
measure: Immuno-modulatory properties of breastmilk
timeFrame: 6 months
measure: Antimicrobial properties of breastmilk microbiota
timeFrame: 6 months
Other outcomes:
Locations:
city: George Town
country: Malaysia
facility: Main Campus USM
state: Penang
Study officials:
affiliation: Universiti Sains Malaysia
name: Min T Liong, PhD
role: PRINCIPAL_INVESTIGATOR
References: