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

NCT05111990 | Active Not Recruiting

• 1 other identifier: 1-10-72-296-18
• Study Type: observational
• Target: 168
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Breast Milk Collection; Human Milk/Breastfeeding; Human Milk Microbiome; Infant Gut Microbiome

Keywords

milk metabolites, multi-omics, gut microbiome

Outcome Measures

Primary Outcomes (1)

• Metabolite profile of human milk

  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.

  Birth to 3 months

Secondary Outcomes (12)

• Metabolite profile of human milk by Liquid Chromatography-Mass Spectrometry (LC-MS) analysis

  Birth to 3 months

• Milk proteome profile

  Birth to 3 months

• Milk protein post-translational modification (PTM) profile

  Birth to 3 months

• Milk glycome profile

  Birth to 3 months

• Microbial structure of human milk

  Birth to 3 months

Study Arms (3)

Maternal pre-gestational BMI 18.5<25

Maternal pre-gestational BMI 25<30

Maternal pre-gestational BMI >30

Eligibility Criteria

• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Residence in Aarhus area is necessary and Aarhus University Hospital has to be the place of giving birth. This is due to samples being collected by midwifes during labor and when study personnel collect samples in study participants' homes.

You may qualify if:

• 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

You may not qualify if:

• 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
• Infants born after gestational age 37 weeks
• Infants with a birth weight between 2500 g and 5000 g
• Inborn errors of metabolism

Sponsors & Collaborators

• University of Aarhus: lead
• University of Copenhagen: collaborator
• Arla Foods: collaborator
• Aarhus University Hospital: collaborator

Study Sites (1)

Aarhus University

Aarhus, 8200, Denmark

Location

Related Publications (1)

• Overgaard Poulsen K, Astono J, Jakobsen RR, Uldbjerg N, Fuglsang J, Nielsen DS, Sundekilde UK. Influence of maternal body mass index on human milk composition and associations to infant metabolism and gut colonisation: MAINHEALTH - a study protocol for an observational birth cohort. BMJ Open. 2022 Nov 2;12(11):e059552. doi: 10.1136/bmjopen-2021-059552.

  PMID: 36323479 BACKGROUND

Biospecimen

Retention: SAMPLES WITH DNA

Blood sample (mother, Gestational age (GA) week 20-24) Vaginal swap (Copan Eswab; mother at birth) Rectum swap (Copan Eswab; mother at birth) Breast milk (3, 30, 60, 90 days postpartum) Urine (infant; 30, 60, 90 days postpartum) Feces (infant; 30, 60, 90 days and 1, 2, 3, 4, and 5 years postpartum) Saliva (Copan Eswab; infant 30 days postpartum) Breast skin (Copan Eswab; mother 30 days postpartum)

MeSH Terms

Conditions

Breast Milk Expression

Condition Hierarchy (Ancestors)

Breast Feeding; Feeding Behavior; Behavior

Study Officials

• Ulrik K Sundekilde, PhD

  University of Aarhus

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 24, 2021
• First Posted: November 8, 2021
• Study Start: June 1, 2019
• Primary Completion (Estimated): February 28, 2027
• Study Completion (Estimated): April 30, 2028
• Last Updated: April 29, 2026

Record last verified: 2026-04

Locations

DK (1)