Study on mother-infant gut health in Malaysia and China
Breastmilk, Infant Gut Microbiome and the Impact on Infant Health: a Prospective Mother-Infant Cohort Study in Malaysia and China
Universiti Putra Malaysia · NCT04919265
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.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 200 (estimated) |
| Ages | 18 Years to 45 Years |
| Sex | Female |
| Sponsor | Universiti Putra Malaysia (other) |
| Locations | 1 site (Kajang, Selangor) |
| Trial ID | NCT04919265 on ClinicalTrials.gov |
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.
Who should consider this trial
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.
Not a fit: Patients who may not benefit from this study include those with immune deficiencies, multiple pregnancies, or congenital abnormalities in their newborns.
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 performed: 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.
Eligibility criteria
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 this trial is running
Kajang, Selangor
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Gut Microbiota, Gastrointestinal Symptoms, Temperament, Eczema, Asthma, Breast Milk Collection, Gut microbiota, Mother-infant cohort study