Mother-Infant Cohort Study in Malaysia and China
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: No intervention - mother-infant cohort study.
- Who it may be relevant to
- Registry conditions: Gut Microbiota, Gastrointestinal Symptoms, Temperament, Eczema. Basic parameters: 18 years — 45 years · Female.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Malaysia
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
Breastmilk, Infant Gut Microbiome and the Impact on Infant Health: a Prospective Mother-Infant Cohort Study in Malaysia and China
Overview
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).
Detailed description
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.
Interventions
- Other No intervention - mother-infant cohort study
There are no interventions because it is a mother-infant cohort study
Primary outcome measures
- Breastmilk microbiome [Time frame: from birth to 12 months]
- Gut microbiome [Time frame: from birth to 12 months]
Secondary outcome measures (7)
- Temperament [Time frame: 12 months]
- Gastrointestinal symptoms [Time frame: from birth to 12 months]
- Eczema symptoms [Time frame: from birth to 12 months]
- Asthma symptoms [Time frame: from birth to 12 months]
- Infant diet [Time frame: from birth to 12 months]
- Infant height [Time frame: from birth to 12 months]
- Infant weight [Time frame: from birth to 12 months]
Eligibility 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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: Yes
Study design
- Observational model
- Cohort
Study locations
Malaysia · 1 center
- Private hospital — Kajang
Publications
- Gartstein MA, Rothbart MK. Studying infant temperament via the Revised Infant Behavior Questionnaire. Infant Behavior and Development. 2003;26(1):64-86. https://doi.org/10.1016/S0163-6383(02)00169-8
- van Tilburg MA, Rouster A, Silver D, Pellegrini G, Gao J, Hyman PE. Development and Validation of a Rome III Functional Gastrointestinal Disorders Questionnaire for Infants and Toddlers. J Pediatr Gastroenterol Nutr. 2016 Mar;62(3):384-6. doi: 10.1097/MPG.0000000000000962. PMID 26308319
- Williams HC, Burney PG, Hay RJ, Archer CB, Shipley MJ, Hunter JJ, Bingham EA, Finlay AY, Pembroke AC, Graham-Brown RA, et al. The U.K. Working Party's Diagnostic Criteria for Atopic Dermatitis. I. Derivation of a minimum set of discriminators for atopic dermatitis. Br J Dermatol. 1994 Sep;131(3):383-96. doi: 10.1111/j.1365-2133.1994.tb08530.x. PMID 7918015
- Castro-Rodriguez JA, Holberg CJ, Wright AL, Martinez FD. A clinical index to define risk of asthma in young children with recurrent wheezing. Am J Respir Crit Care Med. 2000 Oct;162(4 Pt 1):1403-6. doi: 10.1164/ajrccm.162.4.9912111. PMID 11029352
- Eow SY, Gan WY, Jiang T, Loh SP, Lee LJ, Chin YS, Than LTL, How KN, Thong PL, Liu Y, Zhao J, Chen L. MYBIOTA: A birth cohort on maternal and infant microbiota and its impact on infant health in Malaysia. Front Nutr. 2022 Sep 27;9:994607. doi: 10.3389/fnut.2022.994607. eCollection 2022. PMID 36238465
Identifiers
NCT: NCT04919265 · SANYUANUPM