Breast Milk Collection Clinical Trial
— MAINHEALTHOfficial title:
The Influence of Maternal Health on Human Breast Milk Composition With Potential Downstream Effects on Infant Metabolism and Gut Colonization
Verified date | May 2023 |
Source | University of Aarhus |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
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.
Status | Active, not recruiting |
Enrollment | 168 |
Est. completion date | April 30, 2028 |
Est. primary completion date | February 28, 2027 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | Female |
Age group | N/A and older |
Eligibility | 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 |
Country | Name | City | State |
---|---|---|---|
Denmark | Aarhus University | Aarhus |
Lead Sponsor | Collaborator |
---|---|
University of Aarhus | Aarhus University Hospital, Arla Foods, University of Copenhagen |
Denmark,
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. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | Metabolite profile of human milk by Liquid Chromatography-Mass Spectrometry (LC-MS) analysis | Human milk metabolites by LC-MS-based metabolomics. Data will be analysed as absolute concentrations of milk metabolites; how milk metabolite profiles are related to milk microbial profiles, milk oligosaccharides, infant urine metabolome, and infant fecal microbiomes will be explored using multivariate analyses. | Birth to 3 months | |
Secondary | Milk proteome profile | Human milk proteome by LC-MS-based, bottom-up proteomics. Data will be analysed as relative abundances of milk proteins. | Birth to 3 months | |
Secondary | Milk protein post-translational modification (PTM) profile | Post-translational modifications of human milk proteins is analysed by LC-MS-based and 2D- gel-based proteomics. Data will be analysed as relative abundances of milk protein PTMs. | Birth to 3 months | |
Secondary | Milk glycome profile | Human milk glycome by LC-MS-based glycomics. Data will be analysed as relative abundances of milk glycans. | Birth to 3 months | |
Secondary | Microbial structure of human milk | Human milk microbiome by nanopore sequencing. Data will be analysed as relative abundances of bacteria from phylum to genus levels. | Birth to 3 months | |
Secondary | Microbial structure of infant feces | Infant fecal microbiome by nanopore sequencing. Data will be analysed as relative abundances of bacteria from phylum to genus levels. | Birth to 5 years of age | |
Secondary | Microbial structure of infant oral cavity | Oral cavity microbiome by nanopore sequencing. Data will be analysed as relative abundances of bacteria from phylum to genus levels. | 30 days postpartum | |
Secondary | Microbial structure of mother's skin microbiome | Skin microbiome by nanopore sequencing. Data will be analysed as relative abundances of bacteria from phylum to genus levels. | 30 days postpartum | |
Secondary | Metabolite profile of infant fecal material | Infant fecal metabolome by NMR-based metabolomics. Data will be analysed as absolute concentrations of fecal metabolites | Birth to 5 years of age | |
Secondary | Infant metabolism investigated by infant urine metabolomics | Infant urine metabolome by NMR-based metabolomics. Data will be analysed as absolute concentrations of urine metabolites | Birth to 3 months of age | |
Secondary | Microbial structure of maternal vagina and rectum to investigate vertical transmission of bacteria to infant during birth | Vertical transmission of microbiome from mother to infant. Vaginal and rectal microbiome by nanopore sequencing. Data will be analysed as relative abundances of bacteria from phylum to genus levels. | During birth | |
Secondary | Mother's 24-h dietary recall (myfood24) | Aggregated nutrient intake data (e.g. proteins, vitamins, fibers, omega-3-fatty acids) | During pregnancy (Gestational age 30), 30, 60, and 90 days postpartum. In each case two times within a week (one weekday and one weekend day). |
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