Actively Recruiting

Age: 0Days - 45Years
All Genders
Healthy Volunteers
ID07568561

Maternal Methyl-Nutrient Status During Pregnancy and Its Association With Infant Neurodevelopment: Exploring Potential Mechanisms

Led by Far Eastern Memorial Hospital · Updated on 2026-05-29

240

Participants Needed

2

Research Sites

N/A

Total Duration

On this page

Sponsors

F

Far Eastern Memorial Hospital

Lead Sponsor

F

Fu Jen Catholic University

Collaborating Sponsor

AI-Summary

What this Trial Is About

Researchers are studying how maternal methyl-nutrient levels during pregnancy affect infant brain development and growth. This observational study focuses on nutrients like choline, folate, betaine, and vitamin B12, measuring their intake and blood levels at different pregnancy stages. It also explores genetic, metabolic, and gut microbiome factors to understand how these may influence child development up to 24 months old. Pregnant women aged 20 to 45 receiving care and planning to deliver at a specific hospital are enrolled. Throughout pregnancy, researchers collect dietary information, blood, and stool samples each trimester. At birth, newborn measurements and samples including cord blood and meconium are taken. Children are then followed and assessed for neurodevelopment at 6, 12, and 24 months using well-recognized developmental scales. Participants will visit the study site regularly for sample collection and developmental testing. Researchers analyze blood markers, DNA methylation, gene expression, and gut bacteria to build a detailed picture of influences on early brain development. The study lasts from early pregnancy through the child's first two years, aiming to guide future nutrition recommendations during pregnancy and early childhood.

CONDITIONS

Brief Title

Maternal Methyl-Nutrient Status and Infant Neurodevelopment Study

Who Can Participate

Age: 0Days - 45Years
All Genders
Healthy Volunteers

Eligibility Criteria

Eligible

You may qualify if you...

  • Pregnant women aged 20 to 45 years
  • Singleton pregnancy
  • Receiving routine prenatal care at the study site and planning to deliver at Far Eastern Memorial Hospital
  • Newborns delivered by mothers who participate in this study
Not Eligible

You will not qualify if you...

  • Diagnosed with major chronic diseases such as chronic kidney disease stage 3 or above, liver cirrhosis, or cancer
  • Alcohol consumption during pregnancy
  • Diagnosed with eating disorders or psychiatric conditions that may affect nutrition assessment
  • Newborns diagnosed with congenital anomalies, epilepsy, or severe brain injury
  • Newborns unable to complete neurodevelopmental assessments at 6 months, 1 year, and 2 years at the study site
  • Infants whose mothers have eating disorders or psychiatric conditions affecting nutrition assessment

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

Participants are screened during routine prenatal care visits.

Monitoring

Duration - Approximately 9 months (duration of pregnancy)

Participants are observed throughout pregnancy with assessments of maternal dietary intake, blood and stool samples collected each trimester to evaluate methyl-nutrient status and metabolic biomarkers.

Visits coincide with routine prenatal care in each trimester

Diagnostic Evaluation

Duration - At birth

At birth, infant anthropometric measurements are taken and biological samples including meconium and cord blood are collected for analysis.

1 visit (in-person) at delivery

Long-term Monitoring

Duration - Up to 24 months post-birth

Infants undergo neurodevelopmental assessments at 6, 12, and 24 months of age, with stool samples collected at multiple timepoints to study gut microbiota composition.

3 visits at 6, 12, and 24 months with additional stool sample collections

Trial Site Locations

Total: 2 locations

1

Far Eastern Memorial Hospital

New Taipei City, Taiwan

Not Yet Recruiting

2

Far Eastern Memorial Hospital

New Taipei City, Taiwan

Actively Recruiting

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Research Team

C

CHI MAN KUOK

How is the study designed?

Study Type

OBSERVATIONAL

Masking

N/A

Allocation

N/A

Model

N/A

Primary Purpose

N/A

Number of Arms

1

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