Maternal Health Clinical Trial
— IMiCOfficial title:
International Milk Composition (IMiC) Consortium
The IMiC Consortium will analyze milk from 1000 mother-infant dyads across 4 diverse settings (Tanzania, Pakistan, Burkina Faso and Canada). Samples will be stored centrally at the Manitoba Interdisciplinary Lactation Centre (MILC) biorepository and distributed to multiple laboratories for analysis of macronutrients, micronutrients, oligosaccharides, growth factors, immunoglobulins, cytokines, metabolites and microbes. Data will be harmonized and stored in a central database, and diverse statistical methods will be applied for data integration and analysis.
Status | Recruiting |
Enrollment | 1000 |
Est. completion date | October 31, 2024 |
Est. primary completion date | April 30, 2024 |
Accepts healthy volunteers | |
Gender | All |
Age group | 15 Years and older |
Eligibility | Inclusion Criteria: - CHILD Study: Full term healthy infant; singleton pregnancy; English literary - ELICIT Study: Adult mothers, child <14 days, lives within 25km of Haydom - VITAL Study: Lactating, biological mothers - MISAMEIII Study: Confirmed (pregnancy test/ultrasound) pregnant women 15-40 years old, informed consent, self, parents or husband (for minors; assent). Exclusion Criteria: - CHILD Study: IVF; congenital abnormality; preterm delivery - ELICIT Study: Multiple gestation, birth defects/neonatal illness, weight <1.5g, no intention to breastfeed, will move from area within 18 months - VITAL Study: Use of any ointments or topical solutions immediately prior to sampling, non-consent - MISAMEIII Study: Peanut allergy, gestational age <20weeks, women who will not deliver babies in or live in study area by delivery date. |
Country | Name | City | State |
---|---|---|---|
Canada | Manitoba Interdisciplinary Lactation Centre (MILC) | Winnipeg | Manitoba |
Lead Sponsor | Collaborator |
---|---|
University of Manitoba | Aga Khan University, Antigen Discovery Inc, Bill and Melinda Gates Foundation, Cedars-Sinai Medical Center, Johns Hopkins University, Ludwig-Maximilians - University of Munich, Sapient Bioanalytics, Stanford University, The University of Western Australia, University Ghent, University Health Network, Toronto, University of California, Berkeley, University of California, Davis, University of California, San Diego, University of Idaho, University of Virginia, USDA Beltsville Human Nutrition Research Center, USDA, Western Human Nutrition Research Center |
Canada,
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* Note: There are 25 references in all — Click here to view all references
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Create an international consortium of 4 birth cohorts in Tanzania, Pakistan, Burkina Faso and Canada (Field Site Partners), human milk scientists (Laboratory Partners), and data scientists and biostatisticians (Data Science Partners). | The result of this outcome will be measured by the completion of governance structure and data sharing agreements with all partners. | This outcome is anticipated to reach completion in December 2021. | |
Primary | Create a centralized biorepository of human milk samples from the Field Site Partners, housed at the Manitoba Interdisciplinary Lactation Centre (MILC) at the University of Manitoba in Winnipeg, Manitoba, Canada. | The result of this outcome will be measured by the completion of all milk samples collected, stored and catalogued at MILC. | This outcome is anticipated to reach completion in April 2022. | |
Primary | Create a standardized protocol for the comprehensive analysis of human milk composition using state-of-the-art methods in expert laboratories | The result of this outcome will be measured by the completion of list of target milk components; agreements with laboratories; standard operating procedures (SOPs) for sample collection, processing, shipping and analysis. | This outcome is anticipated to reach completion in December 2021. | |
Primary | Create a harmonized dataset of human milk composition and relevant maternal, infant and environmental data from 1000 dyads | The result of this outcome will be measured by complete, clean, accessible, dataset meeting FAIR (Findable, Accessible, Interoperable, Reusable: www.gofair.org) Guiding Principles, including milk composition data and relevant metadata for all included dyads. | This outcome is anticipated to reach completion in October 2023. | |
Primary | Create an integrated analysis of this dataset | Create an integrated analysis of this dataset, addressing research questions such as:
What are the ranges and distributions of analytes in human milk in different geographic settings? How are various components in human milk correlated with each other? How is breast milk composition influenced by maternal, environmental and sociodemographic factors? The result of this outcome will be measured by answering the above research questions, compiled in reports and open access academic publications |
This outcome is anticipated to reach completion in October 2023. | |
Secondary | A secondary objective of IMiC will be to support data integration across sites to answer important questions. | A secondary objective of IMiC will be to support data integration across sites to answer important questions related to 1) the impact of maternal health and nutrition interventions on breast milk composition, and 2) its relation to infant health, growth and development. Each site will own its own data and will also be independently addressing these same questions by site, as originally intended in their own grants/studies. | This outcome is anticipated to reach completion in October 2023. |
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