Evaluation of Breastmilk Microbiota as a Function for Immunity

Vaginal Infection Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05005286
• Other study ID #: USM/JEPeM/20090500
• Status: Completed
• 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
• 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 85
• Est. completion date: November 30, 2021
• Est. primary completion date: November 30, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: N/A and older

Eligibility

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

Related Conditions & MeSH terms

• Breastmilk Collection
• Infections
• Vaginal Infection

Intervention

Other:
• Past history of vaginal Infections
With or without vaginal infection during pregnancy

Locations

Country	Name	City	State
Malaysia	Main Campus USM	George Town	Penang

Sponsors (1)

Lead Sponsor	Collaborator
Universiti Sains Malaysia

Country where clinical trial is conducted

Malaysia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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