Mother-Infant Cohort Study in Malaysia and China

NCT04919265 | Recruiting

• 1 other identifier: SANYUANUPM
• Study Type: observational
• Target: 200
• Locations: 1 country
• Sites: 1

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).

Conditions

Gut Microbiota; Gastrointestinal Symptoms; Temperament; Eczema; Asthma; Breast Milk Collection

Keywords

Gut microbiota; Mother-infant cohort study; Breastmilk

Outcome Measures

Primary Outcomes (2)

• Breastmilk microbiome

  Breastmilk microbiota composition is determined by using 16S rRNA gene sequencing

  from birth to 12 months

• Gut microbiome

  Gut microbiome diversity profile is analysed from the stool by using qPCR and sequencing approaches analysis

  from birth to 12 months

Secondary Outcomes (7)

• Temperament

  12 months

• Gastrointestinal symptoms

  from birth to 12 months

• Eczema symptoms

  from birth to 12 months

• Asthma symptoms

  from birth to 12 months

• Infant diet

  from birth to 12 months

Study Arms (1)

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.

Other: No intervention - mother-infant cohort study

Interventions

No intervention - mother-infant cohort study OTHER

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

Mother and Infant

Eligibility Criteria

• Age: 18 Years - 45 Years
• Gender Eligibility Details: Pregnant women in the first trimester of pregnancy will be recruited.
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)
• 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.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Universiti Putra Malaysia: lead
• Guilin University of Technology, China: collaborator
• National Engineering Center of Dairy for Maternal and Child Health, Beijing: collaborator

Study Sites (1)

Private hospital

Kajang, Selangor, 43000, Malaysia

RECRUITING

Related Publications (5)

• 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

  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.

  PMID: 26308319 BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

• 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 DERIVED

Biospecimen

Retention: SAMPLES WITH DNA

During pregnancy: maternal blood. At delivery: mother's milk. During infancy: Mother's saliva, blood, milk, feces, and urine as well as baby's saliva, blood, feces, and urine.

MeSH Terms

Conditions

Eczema; Asthma; Breast Milk Expression

Condition Hierarchy (Ancestors)

Dermatitis; Skin Diseases; Skin and Connective Tissue Diseases; Skin Diseases, Eczematous; Bronchial Diseases; Respiratory Tract Diseases; Lung Diseases, Obstructive; Lung Diseases; Respiratory Hypersensitivity; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases; Breast Feeding; Feeding Behavior; Behavior

Study Officials

• Wan Ying Gan, PhD

  Universiti Putra Malaysia

  PRINCIPAL INVESTIGATOR

• Tie Min Jiang

  Guilin University of Technology

  PRINCIPAL INVESTIGATOR

• Li Jun Chen, PhD

  Beijing Sanyuan Foods Co Ltd

  STUDY DIRECTOR

Central Study Contacts

Shiang Yen Eow, PhD student

CONTACT

017-6803715; cescvin423@hotmail.com

Wan Ying Gan, PhD

CONTACT

012-3564352; wanying@upm.edu.my

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assoc. Prof. Dr.

Study Record Dates

• First Submitted: May 19, 2021
• First Posted: June 9, 2021
• Study Start: June 3, 2022
• Primary Completion: December 1, 2025
• Study Completion (Estimated): December 1, 2026
• Last Updated: December 13, 2024

Record last verified: 2024-12

Data Sharing

• IPD Sharing: Will not share

Locations

MY (1)