Gut MicrobiotaNCT04919265
Mother-Infant Cohort Study in Malaysia and China
An observational study of Gut Microbiota and Gastrointestinal Symptoms, run by Universiti Putra Malaysia at 1 site in Malaysia.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 45 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Gut Microbiota, Gastrointestinal Symptoms, Temperament
- How many people
- 200 participants
- Where
- 1 siteMalaysia
- Study dates
- 3 Jun 2022to Dec 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 45 years
- Women only
- Healthy volunteers accepted
- Adult
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.
Who may be able to join
- 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
Who cannot join
- 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 locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Malaysia1 site, 1 recruiting
- Recruiting
Private hospital
Kajang, Selangor, 43000
Private hospital
About this study
Official title: Breastmilk, Infant Gut Microbiome and the Impact on Infant Health: a Prospective 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).
Read the 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.
- Conditions
- Gut Microbiota, Gastrointestinal Symptoms, Temperament, Eczema, Asthma, Breast Milk Collection
- Being tested
- No intervention - mother-infant cohort study
- Keywords
- Gut microbiota, Mother-infant cohort study, Breastmilk
- Medical subject headings
- Eczema, Asthma, Breast Milk Expression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
No intervention - mother-infant cohort studyOther
There are no interventions because it is a mother-infant cohort study
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: No intervention - mother-infant cohort study |
What is being measured
The primary outcome is the main question the study is designed to answer.
Breastmilk microbiome
Breastmilk microbiota composition is determined by using 16S rRNA gene sequencing
Measured: from birth to 12 months
Gut microbiome
Gut microbiome diversity profile is analysed from the stool by using qPCR and sequencing approaches analysis
Measured: from birth to 12 months
Secondary outcomes (7)
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.
Measured: 12 months
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.
Measured: from birth to 12 months
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.
Measured: from birth to 12 months
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.
Measured: from birth to 12 months
Infant diet
breastfeeding duration in months
Measured: from birth to 12 months
Infant height
height in cm
Measured: from birth to 12 months
Infant weight
weight in kg
Measured: from birth to 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jun 2021
- Study start3 Jun 2022
- Primary completionDec 2025 (estimated)
- Study completionDec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Gut MicrobiotaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Universiti Putra Malaysia
- Sponsor type
- University, hospital or other
- Collaborators
- Guilin University of Technology, China, National Engineering Center of Dairy for Maternal and Child Health, Beijing
- Responsible party
- Principal investigator, Gan Wan Ying, Universiti Putra Malaysia
- Investigators
- Wan Ying Gan, PhD, Principal investigator, Universiti Putra MalaysiaTie Min Jiang, Principal investigator, Guilin University of TechnologyLi Jun Chen, PhD, Study director, Beijing Sanyuan Foods Co Ltd
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04919265
- Sponsor's protocol ID
- SANYUANUPM
- Status last verified
- Dec 2024
- First submitted
- 19 May 2021
- Last updated
- 13 Dec 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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
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.
PubMed 26308319Williams 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.
PubMed 7918015Castro-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.
PubMed 11029352Eow 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.
PubMed 36238465
Study at a glance
From the registry record, last updated by the sponsor on 13 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Breastmilk, Infant Gut Microbiome and the Impact on Infant Health: a Prospective Mother-Infant Cohort Study in Malaysia and China
- ClinicalTrials.gov ID
- NCT04919265
- Acronym / sponsor ID
- SANYUANUPM
- Conditions
- Gut Microbiota, Gastrointestinal Symptoms, Temperament, Eczema, Asthma, Breast Milk Collection
- Keywords
- Gut microbiota, Mother-infant cohort study, Breastmilk
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Universiti Putra MalaysiaUniversity, hospital or other
- Collaborators
- Guilin University of Technology, China, National Engineering Center of Dairy for Maternal and Child Health, Beijing
- Study start
- 3 Jun 2022 (actual)
- Primary completion
- Dec 2025 (estimated)
- Study completion
- Dec 2026 (estimated)
- First posted
- 9 Jun 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Mother and Infant | – | Other: No intervention - mother-infant cohort studyThe cohort will be followed for 2 years with 8 follow-up measurement points of the infants until the age of 1 year. |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
- 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.
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| No intervention - mother-infant cohort studyThere are no interventions because it is a mother-infant cohort study | Other | Mother and Infant |
Primary outcome
Breastmilk microbiome
Time frame: from birth to 12 months
Breastmilk microbiota composition is determined by using 16S rRNA gene sequencing
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
7 secondary outcomes
Temperament
Time frame: 12 months
Gastrointestinal symptoms
Time frame: from birth to 12 months
Eczema symptoms
Time frame: from birth to 12 months
Asthma symptoms
Time frame: from birth to 12 months
Infant diet
Time frame: from birth to 12 months
Infant height
Time frame: from birth to 12 months
Infant weight
Time frame: from birth to 12 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Dec 2024.
- BackgroundGartstein 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: PubMed 26308319van 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.
- Background: PubMed 7918015Williams 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.
- Background: PubMed 11029352Castro-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.
- Derived from this study: PubMed 36238465Eow 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Wan Ying Gan, PhD principal investigator
Universiti Putra Malaysia
Tie Min Jiang principal investigator
Guilin University of Technology
Li Jun Chen, PhD study director
Beijing Sanyuan Foods Co Ltd
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Gut Microbiota and Gastrointestinal Symptoms, run by Universiti Putra Malaysia at 1 site in Malaysia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 13 Dec 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Malaysia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Shiang Yen Eow, PhD student (017-6803715, cescvin423@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Breastmilk microbiome (time frame: from birth to 12 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04919265, which also lists 5 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Dec 2024; AzTrials last refreshed its copy on 7 Nov 2026.