Evaluation of Breastmilk Microbiota as a Function for Immunity

Sponsor
Universiti Sains Malaysia (Other)
Overall Status
Completed
CT.gov ID
NCT05005286
Collaborator
(none)
85
1
12
7.1

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • 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 Design

Study Type:
Observational
Actual Enrollment :
85 participants
Observational Model:
Case-Control
Time Perspective:
Retrospective
Official Title:
Comparison of Microbiota Composition and Antimicrobial Property From Breastmilk of Mothers With and Without Pregnancy Vaginal Infections
Actual Study Start Date :
Dec 1, 2020
Actual Primary Completion Date :
Nov 30, 2021
Actual Study Completion Date :
Nov 30, 2021

Arms and Interventions

Arm 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

Outcome Measures

Primary Outcome Measures

  1. Breastmilk microbiota profiles [6 months]

    Differences in breastmilk microbiota profiles via pyrosequencing from breastmilk of women with or without history of vaginal infection during pregnancy

Secondary Outcome Measures

  1. Immuno-modulatory properties of breastmilk [6 months]

    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

  2. Antimicrobial properties of breastmilk microbiota [6 months]

    Differences in antimicrobial properties against vaginal pathogens using breastmilk of women with or without history of vaginal infection during pregnancy

Eligibility Criteria

Criteria

Ages Eligible for Study:
N/A and Older
Sexes Eligible for Study:
Female
Accepts Healthy Volunteers:
Yes
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Main Campus USM George Town Penang Malaysia 11800

Sponsors and Collaborators

  • Universiti Sains Malaysia

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Min-Tze LIONG, Professor, Universiti Sains Malaysia
ClinicalTrials.gov Identifier:
NCT05005286
Other Study ID Numbers:
  • USM/JEPeM/20090500
First Posted:
Aug 13, 2021
Last Update Posted:
Mar 18, 2022
Last Verified:
Mar 1, 2022
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Min-Tze LIONG, Professor, Universiti Sains Malaysia
Additional relevant MeSH terms:

Study Results

No Results Posted as of Mar 18, 2022