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Mother-Infant Cohort Study in Malaysia and China

NCT ID: NCT04919265

Last Updated: 2024-12-13

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

200 participants

Study Classification

OBSERVATIONAL

Study Start Date

2022-06-03

Study Completion Date

2026-12-31

Brief Summary

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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

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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.

Conditions

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Gut Microbiota Gastrointestinal Symptoms Temperament Eczema Asthma Breast Milk Collection

Keywords

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Gut microbiota Mother-infant cohort study Breastmilk

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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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.

No intervention - mother-infant cohort study

Intervention Type OTHER

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

Interventions

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No intervention - mother-infant cohort study

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

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

45 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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Guilin University of Technology, China

UNKNOWN

Sponsor Role collaborator

National Engineering Center of Dairy for Maternal and Child Health, Beijing

UNKNOWN

Sponsor Role collaborator

Universiti Putra Malaysia

OTHER

Sponsor Role lead

Responsible Party

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Gan Wan Ying

Assoc. Prof. Dr.

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Wan Ying Gan, PhD

Role: PRINCIPAL_INVESTIGATOR

Universiti Putra Malaysia

Tie Min Jiang

Role: PRINCIPAL_INVESTIGATOR

Guilin University of Technology

Li Jun Chen, PhD

Role: STUDY_DIRECTOR

Beijing Sanyuan Foods Co Ltd

Locations

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Private hospital

Kajang, Selangor, Malaysia

Site Status RECRUITING

Countries

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Malaysia

Central Contacts

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Shiang Yen Eow, PhD student

Role: CONTACT

Phone: 017-6803715

Email: [email protected]

Wan Ying Gan, PhD

Role: CONTACT

Phone: 012-3564352

Email: [email protected]

Facility Contacts

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Private hospital

Role: primary

References

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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

Reference Type BACKGROUND

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.

Reference Type BACKGROUND
PMID: 26308319 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 7918015 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 11029352 (View on PubMed)

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.

Reference Type DERIVED
PMID: 36238465 (View on PubMed)

Other Identifiers

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SANYUANUPM

Identifier Type: -

Identifier Source: org_study_id