- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05111990
Human Milk and Its Effect on Infant's Metabolism and Infant Gut Microbiome (MAINHEALTH)
The Influence of Maternal Health on Human Breast Milk Composition With Potential Downstream Effects on Infant Metabolism and Gut Colonization
Study Overview
Status
Detailed Description
The birth of a living human being is the result of an approximately nine-month pregnancy in which the developing foetus has taken exactly the building blocks necessary to grow and develop from its mother. However, growth and development continues in multiple dimensions at an increasing pace after birth. The nutrition in the first 1,000 days from conception to the child's 2nd birthday plays a pivotal role in shaping the future health of the child. Yet, little is known of how breast milk components vary due to maternal factors or of the biological mechanisms behind the beneficial actions of many breast milk nutrients. The investigators propose to overcome these obstacles by combining specialties to give a more complete account of what breast milk is (major and minor milk constituents and microbiota), how it affects the infants directly or indirectly through breast milk-gut microbiome interactions and by which mechanisms. In this study longitudinal samples from 200 mother-infant dyads during the first year of life across three groups of pregestational maternal BMI; normal weight (BMI 18.5-24.99), overweight (BMI 25-30), and obese (BMI >30) are collected. The samples give a comprehensive record of what the infant has ingested (milk samples) and how the infant and infant gut microbiome responds to this (infant urine and feces). Maternal diet in pregnancy and at milk sample deliveries are recorded through a 24h online food recall and diary system. Maternal health attributes will, besides BMI, be analysed through clinical blood biochemistry parameters. Follow-up samples and infant dietary intake as the infant grows allow investigating how early life diet shaped infant growth and gut colonization more long term. The investigators have formed an experienced team of scientists within metabolomics, microbiology and medicine, holding leading positions within their respective fields in Denmark. The novelty in the study is the interdisciplinarity, unique study design and the emphasis to integrate a number of dynamic measurements thereby offering the ability to identify the factors in breast milk affecting infant metabolism and gut colonization. Knowing this enable the optimization of infant formula.
The research questions asked in this project are three-fold.
- First, the investigators want to determine the variability of breast milk nutrients by application of multi-omics (metabolomics, proteomics and glycomics). The production of human breast milk has a high maternal metabolic cost. Thus, hypothesis is that maternal health attributes (metabolic dysfunction or obesity) influence which breast milk nutrients are made available to the infant.
- Second, the investigators want to establish the microbiome of breast milk. Maternal obesity can lead to an apparent gut microbial ecology and increases the risk of obesity for the child. Thus, the hypothesis is that maternal obesity confers distinct microorganisms to the infant.
- Third, the investigators want to identify biological mechanisms for how breast milk nutrients are metabolised in the infants. Infants exclusively breast-feeding offer total compliance. Thus, the hypothesis is that by deconstructing breast milk components and markers of infant metabolism through comprehensive analysis of infant urine and feces, bioactivity of breast milk nutrients can be elucidated.
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
-
-
-
Aarhus, Denmark, 8200
- Aarhus University
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
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
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
---|
Maternal pre-gestational BMI 18.5<25
|
Maternal pre-gestational BMI 25<30
|
Maternal pre-gestational BMI >30
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Metabolite profile of human milk
Time Frame: 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.
|
Birth to 3 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Metabolite profile of human milk by Liquid Chromatography-Mass Spectrometry (LC-MS) analysis
Time Frame: Birth to 3 months
|
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
|
Milk proteome profile
Time Frame: Birth to 3 months
|
Human milk proteome by LC-MS-based, bottom-up proteomics.
Data will be analysed as relative abundances of milk proteins.
|
Birth to 3 months
|
Milk protein post-translational modification (PTM) profile
Time Frame: Birth to 3 months
|
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
|
Milk glycome profile
Time Frame: Birth to 3 months
|
Human milk glycome by LC-MS-based glycomics.
Data will be analysed as relative abundances of milk glycans.
|
Birth to 3 months
|
Microbial structure of human milk
Time Frame: Birth to 3 months
|
Human milk microbiome by nanopore sequencing.
Data will be analysed as relative abundances of bacteria from phylum to genus levels.
|
Birth to 3 months
|
Microbial structure of infant feces
Time Frame: Birth to 5 years of age
|
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
|
Microbial structure of infant oral cavity
Time Frame: 30 days postpartum
|
Oral cavity microbiome by nanopore sequencing.
Data will be analysed as relative abundances of bacteria from phylum to genus levels.
|
30 days postpartum
|
Microbial structure of mother's skin microbiome
Time Frame: 30 days postpartum
|
Skin microbiome by nanopore sequencing.
Data will be analysed as relative abundances of bacteria from phylum to genus levels.
|
30 days postpartum
|
Metabolite profile of infant fecal material
Time Frame: Birth to 5 years of age
|
Infant fecal metabolome by NMR-based metabolomics.
Data will be analysed as absolute concentrations of fecal metabolites
|
Birth to 5 years of age
|
Infant metabolism investigated by infant urine metabolomics
Time Frame: Birth to 3 months of age
|
Infant urine metabolome by NMR-based metabolomics.
Data will be analysed as absolute concentrations of urine metabolites
|
Birth to 3 months of age
|
Microbial structure of maternal vagina and rectum to investigate vertical transmission of bacteria to infant during birth
Time Frame: 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
|
Mother's 24-h dietary recall (myfood24)
Time Frame: 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).
|
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).
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Ulrik K Sundekilde, PhD, University of Aarhus
Publications and helpful links
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- 1-10-72-296-18
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Breast Milk Collection
-
Ospedale Buon Consiglio FatebenefratelliUniversity of SalernoRecruiting
-
University of TurkuRecruiting
-
Heilongjiang Feihe Dairy Co. Ltd.Recruiting
-
Chinese University of Hong KongUnknown
-
Heilongjiang Feihe Dairy Co. Ltd.CompletedBreast Milk Collection
-
EnzymotecCompletedBreast Milk CollectionIsrael
-
Washington State UniversityUnknownBreast Milk CollectionUnited States
-
Istanbul UniversityRecruiting
-
Vilnius UniversityUniversity of CagliariCompleted
-
Zhujiang HospitalRecruitingHealthy | Feces | Breast-milk CollectionChina