Evaluation of Breastmilk Microbiota as a Function for Immunity

Comparison of Microbiota Composition and Antimicrobial Property From Breastmilk of Mothers With and Without Pregnancy Vaginal Infections

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

Study Overview

• Status: Completed
• Conditions: Vaginal Infection; Breastmilk Collection
• Intervention / Treatment: Other: Past history of vaginal Infections

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.

• Study Type: Observational
• Enrollment (Actual): 85

Contacts and Locations

Study Locations

• Malaysia
  • Penang
    • George Town, Penang, Malaysia, 11800
      • Main Campus USM

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

• 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.

Description

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

Study Plan

How is the study designed?

Design Details

• Observational Models: Case-Control
• Time Perspectives: Retrospective

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Group A; Lactating women with vaginal infection during pregnancy as confirmed by past medical records	Other: Past history of vaginal Infections; With or without vaginal infection during pregnancy
Group B; Lactating women without any vaginal infection during pregnancy

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Breastmilk microbiota profiles	Differences in breastmilk microbiota profiles via pyrosequencing from breastmilk of women with or without history of vaginal infection during pregnancy	6 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Immuno-modulatory properties of breastmilk	Differences in breastmilk concentrations of immunity parameters such as immunoglobulins and cytokines from breastmilk of women with or without history of vaginal infection during pregnancy	6 months
Antimicrobial properties of breastmilk microbiota	Differences in antimicrobial properties against vaginal pathogens using breastmilk of women with or without history of vaginal infection during pregnancy	6 months

Collaborators and Investigators

• Sponsor: Universiti Sains Malaysia
• Investigators: Principal Investigator: Min T Liong, PhD, Universiti Sains Malaysia

Study record dates

Study Major Dates

• Study Start (Actual): December 1, 2020
• Primary Completion (Actual): November 30, 2021
• Study Completion (Actual): November 30, 2021

Study Registration Dates

• First Submitted: August 8, 2021
• First Submitted That Met QC Criteria: August 8, 2021
• First Posted (Actual): August 13, 2021

Study Record Updates

• Last Update Posted (Actual): March 18, 2022
• Last Update Submitted That Met QC Criteria: March 17, 2022
• Last Verified: March 1, 2022

More Information

Terms related to this study

• Keywords: Breastmilk; Vaginal Infection; Immunity properties
• Additional Relevant MeSH Terms: Infections
• Other Study ID Numbers: USM/JEPeM/20090500

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No