Evaluation of Breastmilk Microbiota as a Function for Immunity

Universiti Sains Malaysia

Status: Completed

Conditions: Breastmilk Collection; Vaginal Infection

Treatments: Other: Past history of vaginal Infections

Study type: Observational

Funder types: Other

Identifiers

NCT05005286

USM/JEPeM/20090500

Details and patient eligibility

About

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

Full 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.

Enrollment: 85 patients

Sex: Female

Volunteers: Accepts Healthy Volunteers

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

Trial design

85 participants in 2 patient groups

Group A

Description:

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

Treatment:

Other: Past history of vaginal Infections

Group B

Description:

Lactating women without any vaginal infection during pregnancy