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Evolutionary and Sociocultural Aspects of Human Milk Composition (INSPIRE)

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ClinicalTrials.gov Identifier: NCT02670278
Recruitment Status : Unknown
Verified January 2016 by Washington State University.
Recruitment status was:  Recruiting
First Posted : February 1, 2016
Last Update Posted : February 1, 2016
Sponsor:
Information provided by (Responsible Party):
Washington State University

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.

Condition or disease
Breast Milk Collection

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Study Type : Observational
Estimated Enrollment : 960 participants
Time Perspective: Cross-Sectional
Study Start Date : May 2014
Estimated Primary Completion Date : August 2018

Group/Cohort
US-Washington, Idaho
healthy breastfeeding women and their infants
US-California
healthy breastfeeding women and their infants
Sweden
healthy breastfeeding women and their infants
Spain
healthy breastfeeding women and their infants
Peru
healthy breastfeeding women and their infants
Kenya
healthy breastfeeding women and their infants
Ethiopia-rural
healthy breastfeeding women and their infants
Ethiopia-urban
healthy breastfeeding women and their infants
The Gambia-rural
healthy breastfeeding women and their infants
The Gambia-urban
healthy breastfeeding women and their infants
Ghana
healthy breastfeeding women and their infants



Primary Outcome Measures :
  1. Microbial community structure of milk [ Time Frame: 1-3 months postpartum ]
    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.


Secondary Outcome Measures :
  1. Sociocultural data of women, including dietary intake patterns and microbial exposures [ Time Frame: 1-3 months postpartum ]
    Collected via surveys; multivariate analysis will be conducted to relate these factors to variation in primary outcomes - particularly microbial community structure of milk.

  2. Microbial community structure of infant feces [ Time Frame: 1-3 months of life ]
    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.

  3. Oligosaccharide profiles of milk [ Time Frame: 1-3 months postpartum ]
    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.


Other Outcome Measures:
  1. Maternal genomic variation related to via SNP analysis and/or genome-wide association studies [ Time Frame: 1-3 months postpartum ]
    Funding not yet obtained; when garnered, we will explore relationships between maternal genomics and milk oligosaccharide profiles.


Biospecimen Retention:   Samples With DNA
milk, feces, saliva


Information from the National Library of Medicine

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Ages Eligible for Study:   1 Month and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Healthy breastfeeding women and their infants
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02670278


Contacts
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Contact: Michelle K McGuire, PhD 208-596-5032 smcguire@wsu.edu
Contact: Mark A McGuire, PhD 208-301-2334 mmcguire@uidaho.edu

Locations
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United States, Washington
School of Biological Sciences Recruiting
Pullman, Washington, United States, 99164
Contact: Michelle McGuire, PhE         
Sponsors and Collaborators
Washington State University
Investigators
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Principal Investigator: Michelle K McGuire, PhD Washington State University

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Washington State University
ClinicalTrials.gov Identifier: NCT02670278     History of Changes
Other Study ID Numbers: 24300409
First Posted: February 1, 2016    Key Record Dates
Last Update Posted: February 1, 2016
Last Verified: January 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No