Clinical trial NCT04919265: Mother-Infant Cohort Study 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
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Gut Microbiota
Gastrointestinal Symptoms
Temperament
Eczema
Asthma
Breast Milk Collection
Keywords: Gut microbiota
Mother-infant cohort study
Breastmilk
Lead sponsor: Universiti Putra Malaysia
Sponsor class: OTHER
Collaborators: name: Guilin University of Technology, China
name: National Engineering Center of Dairy for Maternal and Child Health, Beijing
First posted: 2021-06-09
Enrollment: 200
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Pregnant women in their first trimester of pregnancy (gestational age of less than 12 weeks) who visit the selected health clinics/hospitals will be invited to participate in this study.

Brief summary: 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.

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

Primary outcomes:
measure: Breastmilk microbiome
timeFrame: from birth to 12 months
measure: Gut microbiome
timeFrame: from birth to 12 months
Secondary outcomes:
measure: Temperament
timeFrame: 12 months
measure: Gastrointestinal symptoms
timeFrame: from birth to 12 months
measure: Eczema symptoms
timeFrame: from birth to 12 months
measure: Asthma symptoms
timeFrame: from birth to 12 months
measure: Infant diet
timeFrame: from birth to 12 months
measure: Infant height
timeFrame: from birth to 12 months
measure: Infant weight
timeFrame: from birth to 12 months
Other outcomes:
Locations:
city: Kajang
country: Malaysia
facility: Private hospital
state: Selangor
Study officials:
affiliation: Universiti Putra Malaysia
name: Wan Ying Gan, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Guilin University of Technology
name: Tie Min Jiang
role: PRINCIPAL_INVESTIGATOR
affiliation: Beijing Sanyuan Foods Co Ltd
name: Li Jun Chen, PhD
role: STUDY_DIRECTOR
References:
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citation: 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.
citation: 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.
citation: 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.