Clinical trial Recruiting at 1 site Observational Ages 18 to 45 Women only

Study on mother-infant gut health in Malaysia and China

Official title: Breastmilk, Infant Gut Microbiome and the Impact on Infant Health: a Prospective Mother-Infant Cohort Study in Malaysia and China

Run by Universiti Putra Malaysia · NCT04919265 · Data updated 2026-11-12

This study looks at how the types of bacteria in breast milk from mothers in Malaysia and China might affect their babies' health and development during the first year of life.

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Quick facts

Study typeObservational
Ages18 Years to 45 Years
SexWomen only
Enrollment200 (estimated)
SponsorUniversiti Putra Malaysia
Academic / other
Locations1 site (Kajang, Selangor)
StatusRecruiting
StartedJune 3, 2022
Main results expectedDecember 2025
Study endsDecember 2026
Registry record updatedDecember 13, 2024
Trial IDNCT04919265 on ClinicalTrials.gov

Is this trial a fit for you?

Likely a good fit

Ideal candidates for this study are pregnant women aged 18 to 45 who are in their first trimester and plan to attend post-natal check-ups for at least one year.

Probably not a fit

Patients who may not benefit from this study include those with immune deficiencies, multiple pregnancies, or congenital abnormalities in their newborns.

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This observational cohort study investigates the differences in breast milk microbial profiles from mothers in Malaysia and China, focusing on how these differences may influence infant health outcomes such as temperament, gastrointestinal symptoms, eczema, and asthma. Pregnant women will be followed from their first trimester through the first year of their infant's life, with multiple data collection points to assess the impact of gut microbiota on development. The study aims to enhance understanding of the prenatal and postnatal factors that contribute to healthy gut microbiome development in infants.

Why it matters

Potential benefit: If successful, this study could provide insights into how maternal health and diet influence infant gut health, potentially leading to improved health outcomes for infants.

How similar studies have gone: While there have been studies on gut microbiota and infant health, this specific cohort comparison between Malaysia and China is novel and has not been extensively tested.

Who can join: the full rules

Show full inclusion / exclusion criteria
Inclusion Criteria:

* Pregnant women aged between 18 and 45 years old
* Pregnant women who attend the antenatal check-up at the selected clinics/hospitals
* Pregnant women with the gestational age of less than 12 weeks
* Pregnant women who plan to attend post-natal check-ups for at least one year at the same clinic/hospital

Exclusion Criteria:

* Pregnant women who are diagnosed with immune deficiency
* Pregnant women who have a multiple pregnancy and preterm delivery (\<37 weeks)
* Pregnant women who plan to move out of the study area in the next one year
* Pregnant women with fetal/newborn with congenital abnormalities

Where it's running

  • Private hospital
    Kajang, Selangor, Malaysia
    Recruiting

Study contacts

  • Principal investigator: Wan Ying Gan, PhD — Universiti Putra Malaysia
  • Study coordinator: Shiang Yen Eow, PhD student
  • Email: cescvin423@hotmail.com
  • Phone: 017-6803715

Similar studies

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How to take part

  1. Review the eligibility criteria above with your treating physician.
  2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
  3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.
Last reviewed 2026-11-14 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.