Evaluation of Breastmilk Microbiota as a Function for Immunity

NCT05005286 | Completed

• 1 other identifier: USM/JEPeM/20090500
• Study Type: observational
• Target: 85
• Locations: 1 country
• Sites: 1

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.

Conditions

Vaginal Infection; Breastmilk Collection

Keywords

Breastmilk; Vaginal Infection; Immunity properties

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• Immuno-modulatory properties of breastmilk

  6 months

• Antimicrobial properties of breastmilk microbiota

  6 months

Study Arms (2)

Group A

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

Other: Past history of vaginal Infections

Group B

Lactating women without any vaginal infection during pregnancy

Interventions

Past history of vaginal Infections OTHER

With or without vaginal infection during pregnancy

Group A

Eligibility Criteria

• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• Lactating women
• Willing to commit throughout the experiment

You may not qualify if:

• 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

Sponsors & Collaborators

• Universiti Sains Malaysia: lead

Study Sites (1)

Main Campus USM

George Town, Pulau Pinang, 11800, Malaysia

Location

Biospecimen

Retention: SAMPLES WITH DNA

Human breastmilk samples will be collected in this study. 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.

MeSH Terms

Conditions

Vaginitis; Breast Milk Expression

Condition Hierarchy (Ancestors)

Vaginal Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases; Breast Feeding; Feeding Behavior; Behavior

Study Officials

• Min T Liong, PhD

  Universiti Sains Malaysia

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: August 8, 2021
• First Posted: August 13, 2021
• Study Start: December 1, 2020
• Primary Completion: November 30, 2021
• Study Completion: November 30, 2021
• Last Updated: March 18, 2022

Record last verified: 2022-03

Data Sharing

• IPD Sharing: Will not share

Locations

MY (1)