Active — Not RecruitingNot Applicable

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

Denmark168 participantsStarted 2019-06-01

Plain-language 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.

Who can participate

SexFEMALE

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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

What they're measuring

Metabolite profile of human milk

Timeframe: Birth to 3 months

Trial details

NCT IDNCT05111990

SponsorUniversity of Aarhus

Sponsor typeOTHER

Study typeOBSERVATIONAL

Primary completion2027-02-28

View on ClinicalTrials.gov More Breast Milk Collection trials