Evaluation of Breastmilk Microbiota as a Function for Immunity

NCT ID: NCT05005286

Last Updated: 2022-03-18

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 85 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2020-12-01
• Study Completion Date: 2021-11-30

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.

Conditions

Vaginal Infection; Breastmilk Collection

Study Design

• Observational Model Type: CASE_CONTROL
• Study Time Perspective: RETROSPECTIVE

Study Groups

Group A

Lactating women with vaginal infection during pregnancy as confirmed by past medical records

Past history of vaginal Infections

Intervention Type: OTHER

With or without vaginal infection during pregnancy

Group B

Lactating women without any vaginal infection during pregnancy

No interventions assigned to this group

Interventions

Past history of vaginal Infections

With or without vaginal infection during pregnancy

Intervention Type: OTHER

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

• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

Universiti Sains Malaysia

OTHER

Sponsor Role: lead

Responsible Party

Min-Tze LIONG

Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Min T Liong, PhD

Role: PRINCIPAL_INVESTIGATOR

Universiti Sains Malaysia

Locations

Main Campus USM

George Town, Pulau Pinang, Malaysia

Countries

Malaysia

Other Identifiers

USM/JEPeM/20090500

Identifier Type: -

Identifier Source: org_study_id