Mother-Infant Cohort Study in Malaysia and China
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexFemale
Age18-45
SponsorUniversiti Putra Malaysia
About this trial
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).
Eligibility criteria
This trial accepts healthy volunteersQualifiers
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
Disqualifiers
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
Trial 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.
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
No intervention - mother-infant cohort study
Other interventionThere are no interventions because it is a mother-infant cohort study
Treatment groups
200 Participants
are divided into 1 treatment groupGroup A: Mother and Infant1 intervention
Trial outcomes
Primary outcomes
1
Breastmilk microbiome
Breastmilk microbiota composition is determined by using 16S rRNA gene sequencing
Time frame
from birth to 12 months2
Gut microbiome
Gut microbiome diversity profile is analysed from the stool by using qPCR and sequencing approaches analysis
Time frame
from birth to 12 monthsSecondary outcomes
1
Temperament
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.
Time frame
12 months2
Gastrointestinal symptoms
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.
Time frame
from birth to 12 months3
Eczema symptoms
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.
Time frame
from birth to 12 months4
Asthma symptoms
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.
Time frame
from birth to 12 monthsSponsors and contacts
Click on the lead sponsor to view all of their trials.
Universiti Putra Malaysia
Lead sponsor
Guilin University of Technology, China
Collaborator
National Engineering Center of Dairy for Maternal and Child Health, Beijing
Collaborator
Source ClinicalTrials.gov