Clinical Trials

Mother-Infant Cohort Study in Malaysia and China

Study Purpose

This mother-infant cohort study aims to determine the geographic differences in the microbial profiles in breast milk from mothers living in Malaysia and China that are potentially important determinants of infant development. It also aims to determine the impact of gut microbiome on infant health (temperament, gastrointestinal symptoms, eczema symptoms, and asthma symptoms).

Recruitment Criteria

Accepts Healthy Volunteers Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms	Yes
Study Type An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes. An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes. Searching Both is inclusive of interventional and observational studies.	Observational
Eligible Ages	18 Years - 45 Years
Gender	Female

More 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

Trial Details

Trial ID: This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.	NCT04919265
Phase Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans. Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data. Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs. Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.
Lead Sponsor The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.	Universiti Putra Malaysia
Principal Investigator The person who is responsible for the scientific and technical direction of the entire clinical study.	Wan Ying Gan, PhDTie Min JiangLi Jun Chen, PhD
Principal Investigator Affiliation	Universiti Putra MalaysiaGuilin University of TechnologyBeijing Sanyuan Foods Co Ltd
Agency Class Category of organization(s) involved as sponsor (and collaborator) supporting the trial.	Other
Overall Status	Recruiting
Countries	Malaysia
Conditions The disease, disorder, syndrome, illness, or injury that is being studied.	Gut Microbiota, Gastrointestinal Symptoms, Temperament, Eczema, Asthma, Breast Milk Collection

Additional Details

Gut microbiota plays a critical role in children's developmental pathways especially in the first 1000 days of life. A number of pre- and post-natal factors were known to affect gut microbiota in infants during their first year of life including mode of delivery, infant feeding practices, dietary intake, and human milk composition. However, there is no mother-infant cohort study comparing gut microbiota profile and breastmilk composition of mothers living in Malaysia and China. Recent studies showed that gut microbiota was associated with infant health including temperament, gastrointestinal disorders, eczema, and asthma. However, little is known about the gut microbiome and the factors that contribute to microbial variation in the gut of South East Asian children. Increased awareness on the importance of gut health helps establish pre-natal and post-natal factors that promote healthy development and functioning of immune system, gastrointestinal health, and metabolism in infants. This study is a prospective cohort study involving pregnant women in the first trimester of pregnancy. Data will be collected from the eligible pregnant women during their first trimester (8-12 weeks of gestation), second trimester (24 weeks of gestation), third trimester (34 weeks of gestation) and follow-up infants and mothers postnatally after birth (1-5 days after delivery), at 10-15 days, 1 month, 4 months and 12 months of age with a total of 8 follow-ups of mother-infant biological samples and related research data. Mothers will be interviewed on socio-demographic background and information on pre-natal and post-natal factors such as obstetric history, exposure to antibiotics/prebiotics/probiotics/ paracetamol, pre-pregnancy body BMI, gestational weight gain, GDM, physical activity, food security, smoking during pregnancy/second-hand exposure, dietary intake, stress during pregnancy, home settings, pet keeping, and post-natal depression. Mothers will also be interviewed on their infants' sex, birth order, gestational age, mode of delivery, body weight, length, and head circumferences, second hand smoke exposure, exposure to antibiotics/prebiotics/probiotics/paracetamol, infant feeding practices, dietary intake, and dietary diversity. Anthropometric measurements of mothers and infants will be conducted at every visit. Blood, fecal, saliva, and urine samples of mothers and infants will also be collected. All bio-specimens are stored at -80°C until they are transported to National Engineering Center of Dairy for Maternal and Child Health, Beijing, China for further analysis.

Arms & Interventions

Arms

: Mother and Infant

The cohort will be followed for 2 years with 8 follow-up measurement points of the infants until the age of 1 year.

Interventions

Other: - No intervention - mother-infant cohort study

There are no interventions because it is a mother-infant cohort study

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

International Sites

Private hospital, Kajang 10941913, Selangor 1733037, Malaysia

Status

Recruiting

Address

Private hospital

Kajang 10941913, Selangor 1733037, 43000

Site Contact