Evolutionary and Sociocultural Aspects of Human Milk Composition (INSPIRE)

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.

Study Overview

• Status: Unknown
• Conditions: Breast Milk Collection

• Study Type: Observational
• Enrollment (Anticipated): 960

Contacts and Locations

• Study Contact: Name: Michelle K McGuire, PhD; Phone Number: 208-596-5032; Email: smcguire@wsu.edu
• Study Contact Backup: Name: Mark A McGuire, PhD; Phone Number: 208-301-2334; Email: mmcguire@uidaho.edu

Study Locations

• United States
  • Washington
    • Pullman, Washington, United States, 99164
      • Recruiting
      • School of Biological Sciences
      • Contact: Michelle McGuire, PhE

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 1 month and older (ADULT, OLDER_ADULT, CHILD)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Healthy breastfeeding women and their infants

Description

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 Plan

How is the study designed?

Number of groups / cohorts

11

Cohorts and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
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

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Washington State University
• Investigators: Principal Investigator: Michelle K McGuire, PhD, Washington State University

Publications and helpful links

General Publications

• Ruiz L, Alba C, Garcia-Carral C, Jimenez EA, Lackey KA, McGuire MK, Meehan CL, Foster J, Sellen DW, Kamau-Mbuthia EW, Kamundia EW, Mbugua S, Moore SE, Prentice AM, Gindola K D, Otoo GE, Pareja RG, Bode L, McGuire MA, Williams JE, Rodriguez JM. Comparison of Two Approaches for the Metataxonomic Analysis of the Human Milk Microbiome. Front Cell Infect Microbiol. 2021 Mar 25;11:622550. doi: 10.3389/fcimb.2021.622550. eCollection 2021.
• Ruiz L, Espinosa-Martos I, Garcia-Carral C, Manzano S, McGuire MK, Meehan CL, McGuire MA, Williams JE, Foster J, Sellen DW, Kamau-Mbuthia EW, Kamundia EW, Mbugua S, Moore SE, Kvist LJ, Otoo GE, Lackey KA, Flores K, Pareja RG, Bode L, Rodriguez JM. What's Normal? Immune Profiling of Human Milk from Healthy Women Living in Different Geographical and Socioeconomic Settings. Front Immunol. 2017 Jun 30;8:696. doi: 10.3389/fimmu.2017.00696. eCollection 2017.
• McGuire MK, Meehan CL, McGuire MA, Williams JE, Foster J, Sellen DW, Kamau-Mbuthia EW, Kamundia EW, Mbugua S, Moore SE, Prentice AM, Kvist LJ, Otoo GE, Brooker SL, Price WJ, Shafii B, Placek C, Lackey KA, Robertson B, Manzano S, Ruiz L, Rodriguez JM, Pareja RG, Bode L. What's normal? Oligosaccharide concentrations and profiles in milk produced by healthy women vary geographically. Am J Clin Nutr. 2017 May;105(5):1086-1100. doi: 10.3945/ajcn.116.139980. Epub 2017 Mar 29.
• McGuire MK, McGuire MA, Price WJ, Shafii B, Carrothers JM, Lackey KA, Goldstein DA, Jensen PK, Vicini JL. Glyphosate and aminomethylphosphonic acid are not detectable in human milk. Am J Clin Nutr. 2016 May;103(5):1285-90. doi: 10.3945/ajcn.115.126854. Epub 2016 Mar 30.

Study record dates

Study Major Dates

• Study Start: May 1, 2014
• Primary Completion (ANTICIPATED): August 1, 2018

Study Registration Dates

• First Submitted: January 20, 2016
• First Submitted That Met QC Criteria: January 27, 2016
• First Posted (ESTIMATE): February 1, 2016

Study Record Updates

• Last Update Posted (ESTIMATE): February 1, 2016
• Last Update Submitted That Met QC Criteria: January 27, 2016
• Last Verified: January 1, 2016

More Information

Terms related to this study

• Other Study ID Numbers: 24300409

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO