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Metabolism, Breastmilk, and Microbiome

NCT03522597 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 2050

Last updated 2025-08-24

No results posted yet for this study

Summary

The objective of this pilot study is to compare breast milk composition in mothers of three different metabolic states (normal weight, obese, and gestational diabetic) and to determine the extent to which breastmilk components are transmitted to the infant gut and are associated with the anthropometric and body composition changes in their infants during the first 6 months of life. It is hypothesized that 1) different maternal metabolic states will be associated with differences in breastmilk microbial communities and breastmilk biochemical features, 2) differences in these breastmilk biomarkers will be transmitted to infants and 3) breastmilk microbial and metabolic features will be associated with infant growth outcomes.

Conditions

Sponsors & Collaborators

  • University of Oklahoma

    collaborator OTHER

  • Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

    collaborator NIH

  • University of Minnesota

    lead OTHER

Principal Investigators

  • Cheryl A Gale, M.D. · University of Minnesota

  • Ellen W Demerath, Ph.D. · University of Minnesota

Eligibility

Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2018-06-01
Primary Completion
2025-07-01
Completion
2025-07-01

Countries

  • United States

Study Locations

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Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03522597 on ClinicalTrials.gov