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Search / Trial NCT06107933

Developmental Impacts of Microplastics Exposure in Early Life

Launched by JOHNS HOPKINS BLOOMBERG SCHOOL OF PUBLIC HEALTH · Oct 24, 2023

Trial Information

Current as of June 26, 2025

Recruiting

Keywords

Microplastic Breastmilk Infant Microplastic Exposure Gut Microbiome Fecal Metabolome

ClinConnect Summary

This clinical trial, titled "Developmental Impacts of Microplastics Exposure in Early Life," is studying how tiny plastic particles, known as micro- and nano-plastics, may affect the development of infants. Researchers want to find out what types of these plastics are found in breast milk, mothers' blood, and infants' stool samples. They will also explore whether the amount of plastic in mothers' breast milk is related to the amount found in their infants' stool. Additionally, the study aims to identify which lifestyle and environmental factors contribute to the amount of plastics mothers may have in their bodies, and whether exposure to these plastics affects infants' growth and birth weight.

To participate in this study, mothers must be about one month postpartum and planning to exclusively breastfeed for at least six months. Participants will be asked to complete questionnaires about their medical history and lifestyle, provide blood, stool, and breast milk samples, and attend a clinical visit for measurements like height and weight. The study is currently looking for participants living in Denver and Boulder, Colorado, and aims to understand the impacts of environmental factors on infant health. This research could help improve our understanding of how exposure to microplastics might influence early development.

Gender

FEMALE

Eligibility criteria

  • Inclusion Criteria:
  • All gender expressions
  • Mothers at 1 or 3 months postpartum (± 2 weeks)
  • Intent to exclusively breastfeed for ≥ 6 months
  • Nulliparous and singleton births
  • Receiving only breast milk from the mother, with no formula supplementation
  • Exclusion Criteria:
  • Physical, mental, or cognitive disability that prevents participation; current incarceration
  • Chronic conditions in mother and/or infant (e.g., heart disease, cancer, autoimmune disease, diabetes, intestinal bowel syndrome/disease), conditions diagnosed for the first time during pregnancy (e.g. gestational diabetes), neurological conditions in mother and/or infant (e.g. epilepsy, seizures), psychological conditions in mother and/or infant (e.g. bipolar disorder), or neurological/psychological conditions diagnosed in mother during or immediately after pregnancy (e.g. postpartum depression)
  • Previously diagnosed with any major illness (e.g., intrauterine growth restriction, birth asphyxia, cancer) or eating disorder or previous gastric band surgery
  • Maternal antibiotic use during pregnancy or the postpartum period. Infant antibiotic use at any time during life or taking medications that could affect plastic exposure or the microbiome, such as medications administered via a plastic syringe.
  • Use of any breast pump except the Silicon Breast Pump for the 14 days prior to the clinical visit.
  • PHQ9 score greater than or equal to 10 indicating clinically relevant symptoms of moderate or worse depression
  • Infants who are intersex
  • Smoking, drug use (including marijuana use), or alcohol abuse

About Johns Hopkins Bloomberg School Of Public Health

The Johns Hopkins Bloomberg School of Public Health is a leading institution dedicated to advancing public health research and education. Renowned for its rigorous academic programs and commitment to improving global health outcomes, the School conducts innovative clinical trials that address pressing health challenges. With a focus on evidence-based practices, multidisciplinary collaboration, and community engagement, the Bloomberg School leverages its extensive resources and expertise to contribute to the development of effective public health interventions and policies. Through its research endeavors, the School aims to enhance population health and inform health policy both locally and globally.

Locations

Boulder, Colorado, United States

Baltimore, Maryland, United States

Patients applied

0 patients applied

Trial Officials

Tanya L Alderete, PhD

Principal Investigator

Johns Hopkins Bloomberg School of Public Health

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported