Breast Milk CollectionINSPIRENCT02670278
Evolutionary and Sociocultural Aspects of Human Milk Composition
An observational study of Breast Milk Collection, run by Washington State University at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 1 month and older
- Conditions the study is for
- Breast Milk Collection
- How many people
- 960 participants
- Where
- 1 siteUnited States
- Study dates
- May 2014to Aug 2018
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 1 month and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Healthy breastfeeding women and their infants
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site, 1 recruiting
- Recruiting
School of Biological Sciences
Pullman, Washington, 99164
Michelle McGuire, PhE
About this study
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.
- Conditions
- Breast Milk Collection
- Medical subject headings
- Breast Milk Expression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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 being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 1-3 months postpartum
Secondary outcomes (3)
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.
Measured: 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.
Measured: 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.
Measured: 1-3 months postpartum
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Feb 2016 (estimated)
- Study startMay 2014
- Primary completionAug 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Breast Milk CollectionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Time perspective
- Cross-sectional
- Enrolment
- 960 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Washington State University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Michelle K McGuire, PhD, Principal investigator, Washington State University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02670278
- Sponsor's protocol ID
- 24300409
- Acronym
- INSPIRE
- Status last verified
- Jan 2016
- First submitted
- 20 Jan 2016
- Last updated
- 1 Feb 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
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.
PubMed 33842385Ruiz 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.
PubMed 28713365McGuire 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.
PubMed 28356278McGuire 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.
PubMed 27030536
Study at a glance
From the registry record, last updated by the sponsor on 1 Feb 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evolutionary and Sociocultural Aspects of Human Milk Composition
- ClinicalTrials.gov ID
- NCT02670278
- Acronym / sponsor ID
- INSPIRE / 24300409
- Conditions
- Breast Milk Collection
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 960 participants (estimated)
- Lead sponsor
- Washington State UniversityUniversity, hospital or other
- Study start
- May 2014
- Primary completion
- Aug 2018 (estimated)
- First posted
- 1 Feb 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Time perspective
- Cross-sectional
- Number of arms
- 11
| Arm | Type | Receives |
|---|---|---|
| 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 |
Who may qualify
- Ages
- 1 month and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Healthy breastfeeding women and their infants
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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.
3 secondary outcomes
Sociocultural data of women, including dietary intake patterns and microbial exposures
Time frame: 1-3 months postpartum
Microbial community structure of infant feces
Time frame: 1-3 months of life
Oligosaccharide profiles of milk
Time frame: 1-3 months postpartum
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Feb 2016.
- Derived from this study: PubMed 33842385Ruiz 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.
- Derived from this study: PubMed 28713365Ruiz 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.
- Derived from this study: PubMed 28356278McGuire 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.
- Derived from this study: PubMed 27030536McGuire 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Michelle K McGuire, PhD principal investigator
Washington State University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Breast Milk Collection, run by Washington State University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 1 Feb 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Michelle K McGuire, PhD (208-596-5032, smcguire@wsu.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Microbial community structure of milk (time frame: 1-3 months postpartum). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02670278, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Feb 2016.