Evolutionary and Sociocultural Aspects of Human Milk Composition

Breast Milk Collection Clinical Trial

— INSPIRE  

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02670278
• Other study ID #: 24300409
• Status: Recruiting
• Phase: N/A
• First received: January 20, 2016
• Last updated: January 27, 2016
• Start date: May 2014

Study information

• Verified date: January 2016
• Source: Washington State University
• Contact: Michelle K McGuire, PhD
• Phone: 208-596-5032
• Email: smcguire[@]wsu.edu
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 960
• Est. primary completion date: August 2018
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 1 Month and older

Eligibility

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

Study Design

Time Perspective: Cross-Sectional

Related Conditions & MeSH terms

• Breast Milk Collection

Locations

Country	Name	City	State
United States	School of Biological Sciences	Pullman	Washington

Sponsors (1)

Lead Sponsor	Collaborator
Washington State University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Maternal genomic variation related to via SNP analysis and/or genome-wide association studies	Funding not yet obtained; when garnered, we will explore relationships between maternal genomics and milk oligosaccharide profiles.	1-3 months postpartum	No
Primary	Microbial community structure of milk	Sequencing 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.	1-3 months postpartum	No
Secondary	Sociocultural data of women, including dietary intake patterns and microbial exposures	Collected via surveys; multivariate analysis will be conducted to relate these factors to variation in primary outcomes - particularly microbial community structure of milk.	1-3 months postpartum	No
Secondary	Microbial community structure of infant feces	Sequencing 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.	1-3 months of life	No
Secondary	Oligosaccharide profiles of milk	Total and individual oligosaccharide concentrations will be determined; how oligosaccharide profiles are related to milk and infant microbiomes will be explores using multivariate ecological analyses.	1-3 months postpartum	No