Skip to content

Evolutionary and Sociocultural Aspects of Human Milk Composition

Status
UNKNOWN
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT02670278
Acronym
INSPIRE
Enrollment
960
Registered
2016-02-01
Start date
2014-05-31
Completion date
Unknown
Last updated
2016-02-01

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Breast Milk Collection

Brief summary

It is well-known that breastfeeding protects infants from illness, especially in the poorest regions of the world. The full nature of this protective effect, however, is less well understood. A major barrier to understanding is the fact that almost nothing is known about the factors that influence the considerable variation in milk composition around the globe, or about the effects of this variation on infant health. This INSPIRE project represents the first comprehensive investigation of the global differences in human milk composition along with the various microbial, evolutionary, environmental, and sociocultural factors that might influence both milk composition and infant health. An international, interdisciplinary collaboration of physiologists, nutritional scientists, anthropologists, microbiologists, and mathematicians will collect biological data from breastfeeding women and their infants, in concert with extensive anthropologic and ecological data, in both developed (US, Spain, Sweden) and developing countries (Central African Republic, Gambia, Ghana, Peru, and Kenya). To test the possibility of a correlation between milk oligosaccharide composition, milk microbiota, and the gastrointestinal microbiome of infants, milk samples and infant fecal samples will be analyzed using state-of-the-art biochemical and genomic techniques. This study will allow important cross-cultural comparisons of milk composition and infant feeding practices; it also will utilize sophisticated computational methods to integrate the extensive, diverse body of combined biological and anthropological data to elucidate the relationships among sociocultural factors, evolutionary history, environmental exposures, microbial constituents and milk composition. The researchers predict that what is considered normal milk composition in one population may not support optimal health in another. This information is crucial to the humanitarian quest to understand how infant nutrition and overall health can be improved around the world. In addition, this project will provide extensive research training opportunities for undergraduate, graduate and postdoctoral scientists.

Interventions

None listed

Sponsors

Washington State University
Lead SponsorOTHER

Study design

Time perspective
CROSS_SECTIONAL

Eligibility

Sex/Gender
ALL
Age
1 Months to No maximum
Healthy volunteers
No

Inclusion criteria

* Breastfeeding or pumping at least 5 times daily (to assure adequate milk production) * Self-reported healthy women and infants * ≥ 18 yr of age (maternal) * 1-3 mo postpartum

Exclusion criteria

* Current indication of breast infection (e.g., breast pain, discomfort, lumps, mastitis with fever, red streaks, or hard red portions of the breast) * Breast pain that the woman does not consider normal for lactation/breastfeeding * Any antibiotics to mother or infant in the previous month (30 days) * Infant has had signs/symptoms of acute illness in the previous 7 days including the following: fever, diarrhea (≥ 3 excessively loose stools in a day), vomiting not associated with feeding, severe cough, rapid breathing

Design outcomes

Primary

MeasureTime frameDescription
Microbial community structure of milk1-3 months postpartumSequencing of microbial 16S gene via MiSeq; data will be analyzed as relative abundances of bacteria from phylum to genus; how milk microbial profiles are related to milk oligosaccharide and infant fecal microbiomes will be explores using multivariate ecological analyses.

Secondary

MeasureTime frameDescription
Sociocultural data of women, including dietary intake patterns and microbial exposures1-3 months postpartumCollected via surveys; multivariate analysis will be conducted to relate these factors to variation in primary outcomes - particularly microbial community structure of milk.
Microbial community structure of infant feces1-3 months of lifeSequencing of microbial 16S gene via MiSeq; data will be analyzed as relative abundances of bacteria from phylum to genus; relationships with milk microbiome and oligosaccharide profiles will be explored using multivariate ecological analyses.
Oligosaccharide profiles of milk1-3 months postpartumTotal and individual oligosaccharide concentrations will be determined; how oligosaccharide profiles are related to milk and infant microbiomes will be explores using multivariate ecological analyses.

Other

MeasureTime frameDescription
Maternal genomic variation related to via SNP analysis and/or genome-wide association studies1-3 months postpartumFunding not yet obtained; when garnered, we will explore relationships between maternal genomics and milk oligosaccharide profiles.

Countries

United States

Contacts

Primary ContactMichelle K McGuire, PhD
smcguire@wsu.edu208-596-5032
Backup ContactMark A McGuire, PhD
mmcguire@uidaho.edu208-301-2334

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 13, 2026