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NCT Number: NCT04919265

Mother-Infant Cohort Study in Malaysia and China

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).

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Key information

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

No intervention - mother-infant cohort study

Other

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

Primary outcomes

  1. Breastmilk microbiome

    Time frame: from birth to 12 months

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

  2. Gut microbiome

    Time frame: from birth to 12 months

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

Secondary outcomes

  1. Temperament

    Time frame: 12 months

    Infant temperament is assessed using Revised Infant Behavior Questionnaire (IBQ-R) (Gartstein & Rothbart, 2003). It consists of 91 items with 14 subscales, including activity level, distress to limitations, high pleasure, low pleasure, soothability, falling reactivity, cuddliness, perceptual sensitivity, sadness, approach, and vocal reactivity. Mothers are requested to report their infants' behaviors during specific events in the past week using a 7-point scale, ranging from 1 (never) to 7 (always). Total scores of each dimensions range from 1 to 7, with a higher dimension score indicates higher tendency towards the dimension.

  2. Gastrointestinal symptoms

    Time frame: from birth to 12 months

    Mothers are required to complete the Rome IV Diagnostic Questionnaire for Pediatric Functional Gastrointestinal Disorders-Toddler (R4PDQ-toddler) about their child's GI symptoms (Van Tilburg et al., 2016). Those who fulfill criteria for the last 3 months with symptom onset at least 6 months prior to diagnosis are considered as having gastrointestinal problem.

  3. Eczema symptoms

    Time frame: from birth to 12 months

    The presence of eczema in infants will be determined based on five questions of the UK Working Party's Diagnostic Criteria for Atopic Dermatitis (Williams et al., 1994) with response options "yes" or "no". Total scores range from 0 to 5. Higher score indicates presence of eczema. Eczema in infants will be identified by the presence of an itchy skin condition plus 2 or more of the followings: (1) History of involvement of skin creases such as folds of elbows, behind the knees, fronts of ankles cheeks, or around the neck, (2) A history of atopic disease in a first-degree relative, (3) A history of a general dry skin, and (4) Visible flexural eczema.

  4. Asthma symptoms

    Time frame: from birth to 12 months

    The Asthma Predictive Index (API) (Castro-Rodríguez et al., 2000) is used to determine the likelihood of infants who may develop asthma. A positive API score requires recurrent episodes of wheezing during the first 3 years of life and 1 of 2 major criteria (physician-diagnosed eczema or parental asthma) or 2 of 3 minor criteria (physician-diagnosis allergic rhinitis, wheezing without colds, or peripheral eosinophilia ≥4%). A loose index (<3 episodes/y and 1 of the major or 2 of the minor criteria) and a stringent index (≥3 episodes/year and 1 of the major or 2 of the minor criteria) are available.

  5. Infant diet

    Time frame: from birth to 12 months

    breastfeeding duration in months

  6. Infant height

    Time frame: from birth to 12 months

    height in cm

  7. Infant weight

    Time frame: from birth to 12 months

    weight in kg

Study contacts

Contact information is provided by the study sponsor or research team.

Shiang Yen Eow, PhD student

CONTACT

[email protected]

017-6803715

Wan Ying Gan, PhD

CONTACT

[email protected]

012-3564352

Sponsors and collaborators

Lead sponsor

Universiti Putra Malaysia

Other

Collaborators

  • Guilin University of Technology, China
  • National Engineering Center of Dairy for Maternal and Child Health, Beijing

Registry information

Official study title

Breastmilk, Infant Gut Microbiome and the Impact on Infant Health: a Prospective Mother-Infant Cohort Study in Malaysia and China

Important dates

Study start
2022
Primary completion
2025
Study completion
2026
First posted
Jun 9, 2021
Registry last updated
Dec 13, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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