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Clinical Trials in Denmark / NCT05111990
Active, not recruiting Observational

Human Milk and Its Effect on Infant's Metabolism and Infant Gut Microbiome

NCT05111990 · tracked via the Priya Life Science Denmark tracker
Sponsor
University of Aarhus
Phase
Observational
Started
2019-06-01
Last updated
2026-04-29

Condition(s) studied

Breast Milk CollectionHuman Milk/BreastfeedingHuman Milk MicrobiomeInfant Gut Microbiome

Study summary

This protocol explains the MAINHEALTH cohort. The study examine the influence of maternal health parameters on human breast milk composition and integrates milk phenotype with infant metabolism and infant gut microbial content and metabolism.

Eligibility

Sex
FEMALE
Min age
—
Max age
—
Healthy volunteers
Accepted
Inclusion Criteria related to mother: * Residing in Aarhus area * Above 18 years of age * BMI above 18.5 kg/m2 * Intention to breastfeed the first four to six months following birth * Be able to communicate in Danish Exclusion Criteria related to mother: * Smoking * Multiple gestation * Suffering from the following chronic diseases that demands medical treatment: diabetes mellitus, celiac disease, inflammatory bowel disease (Chrohn's disease or ulcerosa colitis) * Taking medicaments for irritable bowel syndrome * Taking medicine for metabolic disorders * Taking medicine for psychological disorders * Have had gastric bypass surgery * Planned caesarean section * Received antibiotics after week 12 in their pregnancy * Utilizing significant amount of infant formula following birth Inclusion Criteria related to infant: * Infants born after gestational age 37 weeks * Infants with a birth weight between 2500 g and 5000 g Exclusion Criteria related to infant: • Inborn errors of metabolism

Primary outcome measure(s)

  • Metabolite profile of human milk — Birth to 3 months
    Human milk metabolites by Nuclear Magnetic Resonance (NMR) spectroscopy. Data will be analysed as absolute concentrations of milk metabolites; how milk metabolite profiles are related to mother's blood chemistry, milk microbial profiles, milk oligosaccharides, infant urine metabolome, and infant fecal microbiomes will be explored using multivariate analyses.

Trial sites (1)

FacilityCityRegionStatus
Aarhus University Aarhus Denmark

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT05111990 on ClinicalTrials.gov ↗ ← All trials in Denmark