Infant GrowthIMiCNCT05119166
International Milk Composition (IMiC) Consortium
An observational study of Infant Growth and Maternal Health, run by University of Manitoba at 1 site in Canada.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 15 years and older
- Conditions the study is for
- Infant Growth, Maternal Health, Infant Nutrition
- What is being tested?
- Vitamin B3, Azithromycin and Fortified food supplement
- Type of treatment
- Pill or oral medicine
- How many people
- 1,000 participants
- Where
- 1 siteCanada
- Study dates
- 17 Nov 2019to 30 Oct 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 15 years and older
- All sexes
- Child, Adult, Older adult
Study population: CHILD Study: observational study of healthy term infants from Canada, Multi-ethnic (~70% Caucasian; 30% others: Asian, First Nations, Black, other) ELICIT Study: factorial RCT study design, cohorts from Haydom, Tanzania, predominantly of Black and East African descent VITAL Study: 3-arm RCT study design, cohorts from Karachi, Pakistan, predominantly of Asian descent MISAMEIII Study: 2x2 cross-over RCT study design, cohorts from Hounde District, Burkina Faso, predominantly of Black and West African descent
Who may be able to join
- 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).
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Canada1 site
Manitoba Interdisciplinary Lactation Centre (MILC)
Winnipeg, Manitoba, R3E3P4
About this study
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.
Read the detailed description
Human Milk Composition: Milk is a highly complex biofluid that has evolved over millions of years to nourish infants and protect them from infection while their immune system matures. In addition to delivering complete nutrition (i.e. macronutrients and micronutrients), milk provides bioactive components that further support infant growth, development and health. These include immunoglobulins, antibodies, hormones, growth factors, prebiotic oligosaccharides, and probiotic bacteria. Milk composition is specifically adapted to each mammalian species depending on the growth requirements of their young offspring. For example, the average energy content of human milk is around 70 kcal/100g, compared to 38 kcal/100g in donkey milk and 171 kcal/100g in mouse milk. Mice produce just 2 milk oligosaccharides, while humans produce over 150. Even among humans, milk composition is highly variable - for example, energy content can range from 57-83 kcal/100g and oligosaccharide concentrations range from 5-25 g/L.
Surprisingly little is known about the determinants and consequences of this variation. The investigators will study the following milk components in the IMiC Consortium to understand variability between individual women and across different geographic settings, and their associations with infant growth. In addition, to guide these analyses, a review of human milk components and infant growth will be undertaken by the IMiC members during Year 1 of the Project.
Priority Components (to be analyzed in all samples):
Macronutrients include carbohydrates (primarily lactose), proteins and lipids. Lipids provide about 50% of the energy content in human milk. The vast majority (98%) of milk lipids are triacylglycerides, with the remainder consisting of diacylglycerides, monoacylglycerides, free fatty acids, phospholipids and cholesterol. The fatty acid profile of human milk varies in relation to maternal diet and genetics, particularly in the long-chain polyunsaturated fatty acids (LCPUFAs), such as arachidonic and docosahexaenoic acids, which contribute to immune function and neurodevelopment.
Micronutrient quality and concentrations can be compromised by maternal malnutrition. Micronutrients in milk include minerals (e.g. Zinc, Calcium, Phosphorus, Magnesium, Iodine, Selenium) and vitamins (A, B1, B2, B6, B12, C, D, E; folate, choline).
Immunoglobulins (Ig) are transferred in human milk, including IgA, IgM and IgG. Infants are born with immature adaptive immunity, and rely on these maternal antibodies for defense against pathogens. Soluble IgA (sIgA) is the predominant antibody of human milk; sIgA-antigen complexes are taken up by intestinal dendritic cells, allowing for antigen recognition.
Cytokines are multifunctional peptides can cross the intestinal barrier, where they influence immune activity. Milk-borne cytokines include anti-inflammatory transforming growth factor (TGF)-b, interleukins (IL)-10 and IL-7, and proinflammatory tumor necrosis factor (TNF)-a, IL-6, IL-8, and interferon (IFN)-g.
Lactoferrin is an iron binding glycoprotein with antimicrobial activity against many bacteria, viruses, and fungi. Osteopontin is an extensively phosphorylated acidic glycoprotein that is present at high concentrations in human milk. It affects immune functions, intestinal development, and brain development.
Growth factors and hormones in human milk have wide-ranging effects on the infant intestinal tract, vasculature, nervous system, and endocrine system. Some act locally on the neonatal intestine and many are absorbed into systemic circulation through the 'leaky' infant gut. Epidermal growth factor (EGF) is critical to the maturation and healing of the intestinal mucosa. Insulin-like growth factor (IGF) promotes tissue growth. The metabolic hormones leptin, insulin, adiponectin and ghrelin regulate energy conservation, appetite and infant BMI.
Human milk oligosaccharides (HMOs) are the third most abundant component of human milk. Over 100 different HMOs have been identified. These structurally diverse carbohydrates are not digested by the infant, but are metabolized by the infant's gut bacteria, providing a selective substrate to help shape the developing microbiome. In addition, HMOs serve as soluble decoy receptors and prevent pathogen attachment to infant mucosal surfaces, lowering the risk for viral and bacterial infections. HMOs may also modulate epithelial and immune cell responses and provide the infant with sialic acid, an important nutrient for brain development. In the CHILD cohort the investigators have observed that, beyond genetic secretor status, HMO composition is associated with ethnicity, lactation stage, parity, geographic location, season of collection, and breastfeeding exclusivity.
Omics approaches will be applied to broadly assess the complete spectrum of peptides, proteins, lipids, and metabolites in human milk. Targeted metabolomics analyses to be conducted using the Biocrates platform (~500 metabolites), untargeted metabolomic analyses to be conducted by Sapient Bioanalytics via mass spectrometry.
Microbes are present in human milk. Culture-dependent and independent (sequencing-based) studies have confirmed the presence of bacteria and fungi in milk from healthy mothers. In the CHILD cohort, the investigators have found that milk microbiota composition differs by infant sex, method of feeding, maternal BMI, and maternal atopy. It is estimated that breastfed infants receive 10^4-10^6 bacteria per day, providing a source of live microbes to seed the infant gut, oral cavity and airways. Studies demonstrating strain similarities between maternal gut, milk, and infant gut support this hypothesis, and find that Bifidobacterium spp. constitute the majority of shared taxa between maternal milk and infant stool. Given the central role of the gut microbiome in infant growth, metabolism and protection from infectious disease, including in low to middle income (LMIC) settings, it is critical to understand the origins of these fundamentally important gut microbes early in life.
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.
- Conditions
- Infant Growth, Maternal Health, Infant Nutrition
- Being tested
- Vitamin B3, Azithromycin, Fortified food supplement
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Vitamin B3Dietary supplement
Also called Nicotinamide
ELICIT Study: Factorial design RCT of nicotinamide (vitamin B3) to mothers and infants, and antimicrobial prophylaxis (Azithromycin) to infants.
AzithromycinBiological
ELICIT Study: Factorial design RCT of nicotinamide (vitamin B3) to mothers and infants, and antimicrobial prophylaxis (Azithromycin) to infants.
VITAL Pakistan Study: 3-arm RCT of fortified food supplement (protein energy) during lactation, with or without azithromycin prophylaxis for infant.
Fortified food supplementDietary supplement
VITAL Study: 3-arm RCT of fortified food supplement (protein energy) during lactation, with or without azithromycin prophylaxis for infant.
MISAMEIII Study: 2x2 cross-over efficacy RCT of fortified food supplement (folic acid/iron +/- peanut spread) during pregnancy and/or lactation; unmasked (open label).
| Study group | Role | What they receive |
|---|---|---|
| Canadian Healthy Infant Longitudinal Development (CHILD) Cohort Study | The CHILD Cohort Study is a prospective longitudinal birth cohort study. It is an observational study of healthy term infants in Canada (Vancouver, Edmonton, Manitoba, Toronto). The birth years were between 2009-2012, and is currently at the 8 year postnatal follow up phase. IMiC will receive 400 breast milk samples from 400 dyads (100/site) that were taken between 3-4 months postnatal. | |
| The Early Life Interventions for Childhood Growth and Development in Tanzania (ELICIT) Study | (NCT03268902). ELICIT is a randomized controlled trial (RCT) evaluating the efficacy of antimicrobials and nicotinamide in increasing growth in the setting of Rural Tanzania. It is factorial design RCT of nicotinamide (vitamin B3) to mothers and infants, and antimicrobial prophylaxis to infants. IMiC will receive 400 breast milk samples from 200 dyads, 2 samples per dyad taken at 1 \& 5 months postnatal. Receives: Dietary Supplement: Vitamin B3; Biological: Azithromycin | |
| VITAL Pakistan | Two Randomized Controlled Trials: Mumta (Nutritional support for lactating women with or without azithromycin)PW - NCT04012177 and MumtaLW - NCT03564652 VITAL is a community-based, randomized control, assessor blinded trial in peri-urban settings of Karachi, Pakistan to study the impact of Lipid-based Nutritional Supplement for Pregnant and Lactating women which is balanced energy-protein (BEP) dietary supplement, a locally produced ready-to-use nutritional product for lactating women (LW) and single prophylaxis dose of Azithromycin for infants, on growth of infants over the period of six months since birth compared to current standard of care. IMiC will receive 600 breast milk samples from 200 dyads, 3 samples per dyad taken at 0-1, 1-2 \& 2-3 months. Receives: Biological: Azithromycin; Dietary Supplement: Fortified food supplement | |
| Micronutriments pour la Santé de la Mère et de l'Enfant (MISAME)-3 study (NCT03533712) | MISAME-3 is a randomized controlled clinical trial in the setting of Rural Burkina Faso. A BEP supplement provides less than 25% of protein of the total energy content, and includes different vitamins and minerals. The first part of an exploratory study will determine which type of BEP supplement (bar, drink, biscuit, soup or paste) is most accepted by pregnant women. Subsequently, two products will be tested for longer-term acceptability and at-home use (phase 1). The effect of the most suitable supplement will be tested in a controlled clinical trial (phase 2). The intervention group will receive the dietary supplement during pregnancy and/or lactation, while the control group complies with the standard iron and folic acid tablets following the national guidelines. IMiC will receive 600 breast milk samples from 200 dyads, 3 samples per dyad taken at 0-1, 1-2 \& 3-4 months. Receives: Dietary Supplement: Fortified food supplement |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: This outcome is anticipated to reach completion in December 2021.
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.
Measured: This outcome is anticipated to reach completion in April 2022.
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.
Measured: This outcome is anticipated to reach completion in December 2021.
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.
Measured: This outcome is anticipated to reach completion in October 2023.
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
Measured: This outcome is anticipated to reach completion in October 2023.
Secondary outcomes (1)
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.
Measured: This outcome is anticipated to reach completion in October 2023.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Nov 2021
- Study start17 Nov 2019
- Primary completion30 Oct 2026 (estimated)
- Study completion30 Oct 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (26)Papers the sponsor has linked to this study.
- Other trials for Infant GrowthStudies 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
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 1,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Manitoba
- Sponsor type
- University, hospital or other
- Collaborators
- Bill and Melinda Gates Foundation, Stanford University, The University of Western Australia, University of Idaho, Ludwig-Maximilians - University of Munich, Johns Hopkins University, Cedars-Sinai Medical Center, Sapient Bioanalytics, University of California, Davis, University of California, San Diego, University of Virginia, Aga Khan University, University Ghent, University of California, Berkeley, University Health Network, Toronto, USDA Beltsville Human Nutrition Research Center, Antigen Discovery Inc, USDA, Western Human Nutrition Research Center
- Responsible party
- Sponsor
- Investigators
- Meghan B Azad, Principal investigator, University of Manitoba, CHILD Cohort StudyEstomih Mduma, Study director, Haydom Lutheran Hospital, ELICIT TrialFyezah Jehan, Principal investigator, Aga Khan University Pakistan, VITAL TrialLaeticia Celine Toe, Study director, Institut de Recherche en Science de la Santa, MISAMEIII TrialPJ Subbarao, Study director, SickKids, CHILD StudyYasir Shafiq, Principal investigator, Aga Khan University Pakistan, VITAL TrialMark D DeBoer, Principal investigator, University of Virginia, VITAL TrialPatrick Kolsteren, Principal investigator, Ghent University, MISAMEIII Trial
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05119166
- Sponsor's protocol ID
- HS23767
- Other IDs
- H2020:161
- Acronym
- IMiC
- Status last verified
- May 2026
- First submitted
- 1 Nov 2021
- Last updated
- 7 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Data to be shared: final, annotated datasets and associated documentation (protocols, questionnaires, codebooks, data dictionaries, etc.). Data will be deposited into an open access data repository.
Publications
Andreas NJ, Kampmann B, Mehring Le-Doare K. Human breast milk: A review on its composition and bioactivity. Early Hum Dev. 2015 Nov;91(11):629-35. doi: 10.1016/j.earlhumdev.2015.08.013. Epub 2015 Sep 12.
PubMed 26375355Ballard O, Morrow AL. Human milk composition: nutrients and bioactive factors. Pediatr Clin North Am. 2013 Feb;60(1):49-74. doi: 10.1016/j.pcl.2012.10.002.
PubMed 23178060Bode L. Human milk oligosaccharides: every baby needs a sugar mama. Glycobiology. 2012 Sep;22(9):1147-62. doi: 10.1093/glycob/cws074. Epub 2012 Apr 18.
PubMed 22513036Azad MB, Robertson B, Atakora F, Becker AB, Subbarao P, Moraes TJ, Mandhane PJ, Turvey SE, Lefebvre DL, Sears MR, Bode L. Human Milk Oligosaccharide Concentrations Are Associated with Multiple Fixed and Modifiable Maternal Characteristics, Environmental Factors, and Feeding Practices. J Nutr. 2018 Nov 1;148(11):1733-1742. doi: 10.1093/jn/nxy175.
PubMed 30247646Innis SM. Impact of maternal diet on human milk composition and neurological development of infants. Am J Clin Nutr. 2014 Mar;99(3):734S-41S. doi: 10.3945/ajcn.113.072595. Epub 2014 Feb 5.
PubMed 24500153Dror DK, Allen LH. Overview of Nutrients in Human Milk. Adv Nutr. 2018 May 1;9(suppl_1):278S-294S. doi: 10.1093/advances/nmy022.
PubMed 29846526Dawod B, Marshall JS. Cytokines and Soluble Receptors in Breast Milk as Enhancers of Oral Tolerance Development. Front Immunol. 2019 Jan 22;10:16. doi: 10.3389/fimmu.2019.00016. eCollection 2019.
PubMed 30723472Garofalo R. Cytokines in human milk. J Pediatr. 2010 Feb;156(2 Suppl):S36-40. doi: 10.1016/j.jpeds.2009.11.019.
PubMed 20105664Demmelmair H, Prell C, Timby N, Lonnerdal B. Benefits of Lactoferrin, Osteopontin and Milk Fat Globule Membranes for Infants. Nutrients. 2017 Jul 28;9(8):817. doi: 10.3390/nu9080817.
PubMed 28788066Jiang R, Lonnerdal B. Biological roles of milk osteopontin. Curr Opin Clin Nutr Metab Care. 2016 May;19(3):214-9.
PubMed 27504516Chan D, Goruk S, Becker AB, Subbarao P, Mandhane PJ, Turvey SE, Lefebvre D, Sears MR, Field CJ, Azad MB. Adiponectin, leptin and insulin in breast milk: associations with maternal characteristics and infant body composition in the first year of life. Int J Obes (Lond). 2018 Jan;42(1):36-43. doi: 10.1038/ijo.2017.189. Epub 2017 Aug 14.
PubMed 28925410Young BE, Patinkin Z, Palmer C, de la Houssaye B, Barbour LA, Hernandez T, Friedman JE, Krebs NF. Human milk insulin is related to maternal plasma insulin and BMI: but other components of human milk do not differ by BMI. Eur J Clin Nutr. 2017 Sep;71(9):1094-1100. doi: 10.1038/ejcn.2017.75. Epub 2017 May 17.
PubMed 28513622Moossavi S, Miliku K, Sepehri S, Khafipour E, Azad MB. The Prebiotic and Probiotic Properties of Human Milk: Implications for Infant Immune Development and Pediatric Asthma. Front Pediatr. 2018 Jul 24;6:197. doi: 10.3389/fped.2018.00197. eCollection 2018.
PubMed 30140664Musilova S, Rada V, Vlkova E, Bunesova V. Beneficial effects of human milk oligosaccharides on gut microbiota. Benef Microbes. 2014 Sep;5(3):273-83. doi: 10.3920/BM2013.0080.
PubMed 24913838Wang B. Molecular mechanism underlying sialic acid as an essential nutrient for brain development and cognition. Adv Nutr. 2012 May 1;3(3):465S-72S. doi: 10.3945/an.112.001875.
PubMed 22585926
Study at a glance
From the registry record, last updated by the sponsor on 7 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- International Milk Composition (IMiC) Consortium
- ClinicalTrials.gov ID
- NCT05119166
- Acronym / sponsor ID
- IMiC / HS23767
- Conditions
- Infant Growth, Maternal Health, Infant Nutrition
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 1,000 participants (estimated)
- Lead sponsor
- University of ManitobaUniversity, hospital or other
- Collaborators
- Bill and Melinda Gates Foundation, Stanford University, The University of Western Australia, University of Idaho, Ludwig-Maximilians - University of Munich, Johns Hopkins University, Cedars-Sinai Medical Center, Sapient Bioanalytics, University of California, Davis, University of California, San Diego, University of Virginia, Aga Khan University, University Ghent, University of California, Berkeley, University Health Network, Toronto, USDA Beltsville Human Nutrition Research Center, Antigen Discovery Inc, USDA, Western Human Nutrition Research Center
- Study start
- 17 Nov 2019 (actual)
- Primary completion
- 30 Oct 2026 (estimated)
- Study completion
- 30 Oct 2026 (estimated)
- First posted
- 15 Nov 2021 (actual)
- 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.
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.
Detailed description
Human Milk Composition: Milk is a highly complex biofluid that has evolved over millions of years to nourish infants and protect them from infection while their immune system matures. In addition to delivering complete nutrition (i.e. macronutrients and micronutrients), milk provides bioactive components that further support infant growth, development and health. These include immunoglobulins, antibodies, hormones, growth factors, prebiotic oligosaccharides, and probiotic bacteria. Milk composition is specifically adapted to each mammalian species depending on the growth requirements of their young offspring. For example, the average energy content of human milk is around 70 kcal/100g, compared to 38 kcal/100g in donkey milk and 171 kcal/100g in mouse milk. Mice produce just 2 milk oligosaccharides, while humans produce over 150. Even among humans, milk composition is highly variable - for example, energy content can range from 57-83 kcal/100g and oligosaccharide concentrations range from 5-25 g/L.
Surprisingly little is known about the determinants and consequences of this variation. The investigators will study the following milk components in the IMiC Consortium to understand variability between individual women and across different geographic settings, and their associations with infant growth. In addition, to guide these analyses, a review of human milk components and infant growth will be undertaken by the IMiC members during Year 1 of the Project.
Priority Components (to be analyzed in all samples):
Macronutrients include carbohydrates (primarily lactose), proteins and lipids. Lipids provide about 50% of the energy content in human milk. The vast majority (98%) of milk lipids are triacylglycerides, with the remainder consisting of diacylglycerides, monoacylglycerides, free fatty acids, phospholipids and cholesterol. The fatty acid profile of human milk varies in relation to maternal diet and genetics, particularly in the long-chain polyunsaturated fatty acids (LCPUFAs), such as arachidonic and docosahexaenoic acids, which contribute to immune function and neurodevelopment.
Micronutrient quality and concentrations can be compromised by maternal malnutrition. Micronutrients in milk include minerals (e.g. Zinc, Calcium, Phosphorus, Magnesium, Iodine, Selenium) and vitamins (A, B1, B2, B6, B12, C, D, E; folate, choline).
Immunoglobulins (Ig) are transferred in human milk, including IgA, IgM and IgG. Infants are born with immature adaptive immunity, and rely on these maternal antibodies for defense against pathogens. Soluble IgA (sIgA) is the predominant antibody of human milk; sIgA-antigen complexes are taken up by intestinal dendritic cells, allowing for antigen recognition.
Cytokines are multifunctional peptides can cross the intestinal barrier, where they influence immune activity. Milk-borne cytokines include anti-inflammatory transforming growth factor (TGF)-b, interleukins (IL)-10 and IL-7, and proinflammatory tumor necrosis factor (TNF)-a, IL-6, IL-8, and interferon (IFN)-g.
Lactoferrin is an iron binding glycoprotein with antimicrobial activity against many bacteria, viruses, and fungi. Osteopontin is an extensively phosphorylated acidic glycoprotein that is present at high concentrations in human milk. It affects immune functions, intestinal development, and brain development.
Growth factors and hormones in human milk have wide-ranging effects on the infant intestinal tract, vasculature, nervous system, and endocrine system. Some act locally on the neonatal intestine and many are absorbed into systemic circulation through the 'leaky' infant gut. Epidermal growth factor (EGF) is critical to the maturation and healing of the intestinal mucosa. Insulin-like growth factor (IGF) promotes tissue growth. The metabolic hormones leptin, insulin, adiponectin and ghrelin regulate energy conservation, appetite and infant BMI.
Human milk oligosaccharides (HMOs) are the third most abundant component of human milk. Over 100 different HMOs have been identified. These structurally diverse carbohydrates are not digested by the infant, but are metabolized by the infant's gut bacteria, providing a selective substrate to help shape the developing microbiome. In addition, HMOs serve as soluble decoy receptors and prevent pathogen attachment to infant mucosal surfaces, lowering the risk for viral and bacterial infections. HMOs may also modulate epithelial and immune cell responses and provide the infant with sialic acid, an important nutrient for brain development. In the CHILD cohort the investigators have observed that, beyond genetic secretor status, HMO composition is associated with ethnicity, lactation stage, parity, geographic location, season of collection, and breastfeeding exclusivity.
Omics approaches will be applied to broadly assess the complete spectrum of peptides, proteins, lipids, and metabolites in human milk. Targeted metabolomics analyses to be conducted using the Biocrates platform (~500 metabolites), untargeted metabolomic analyses to be conducted by Sapient Bioanalytics via mass spectrometry.
Microbes are present in human milk. Culture-dependent and independent (sequencing-based) studies have confirmed the presence of bacteria and fungi in milk from healthy mothers. In the CHILD cohort, the investigators have found that milk microbiota composition differs by infant sex, method of feeding, maternal BMI, and maternal atopy. It is estimated that breastfed infants receive 10^4-10^6 bacteria per day, providing a source of live microbes to seed the infant gut, oral cavity and airways. Studies demonstrating strain similarities between maternal gut, milk, and infant gut support this hypothesis, and find that Bifidobacterium spp. constitute the majority of shared taxa between maternal milk and infant stool. Given the central role of the gut microbiome in infant growth, metabolism and protection from infectious disease, including in low to middle income (LMIC) settings, it is critical to understand the origins of these fundamentally important gut microbes early in life.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Canadian Healthy Infant Longitudinal Development (CHILD) Cohort Study | – | –The CHILD Cohort Study is a prospective longitudinal birth cohort study. It is an observational study of healthy term infants in Canada (Vancouver, Edmonton, Manitoba, Toronto). The birth years were between 2009-2012, and is currently at the 8 year postnatal follow up phase. IMiC will receive 400 breast milk samples from 400 dyads (100/site) that were taken between 3-4 months postnatal. |
| The Early Life Interventions for Childhood Growth and Development in Tanzania (ELICIT) Study | – | Dietary Supplement: Vitamin B3, Biological: Azithromycin(NCT03268902). ELICIT is a randomized controlled trial (RCT) evaluating the efficacy of antimicrobials and nicotinamide in increasing growth in the setting of Rural Tanzania. It is factorial design RCT of nicotinamide (vitamin B3) to mothers and infants, and antimicrobial prophylaxis to infants. IMiC will receive 400 breast milk samples from 200 dyads, 2 samples per dyad taken at 1 \& 5 months postnatal. |
| VITAL Pakistan | – | Biological: Azithromycin, Dietary Supplement: Fortified food supplementTwo Randomized Controlled Trials: Mumta (Nutritional support for lactating women with or without azithromycin)PW - NCT04012177 and MumtaLW - NCT03564652 VITAL is a community-based, randomized control, assessor blinded trial in peri-urban settings of Karachi, Pakistan to study the impact of Lipid-based Nutritional Supplement for Pregnant and Lactating women which is balanced energy-protein (BEP) dietary supplement, a locally produced ready-to-use nutritional product for lactating women (LW) and single prophylaxis dose of Azithromycin for infants, on growth of infants over the period of six months since birth compared to current standard of care. IMiC will receive 600 breast milk samples from 200 dyads, 3 samples per dyad taken at 0-1, 1-2 \& 2-3 months. |
| Micronutriments pour la Santé de la Mère et de l'Enfant (MISAME)-3 study (NCT03533712) | – | Dietary Supplement: Fortified food supplementMISAME-3 is a randomized controlled clinical trial in the setting of Rural Burkina Faso. A BEP supplement provides less than 25% of protein of the total energy content, and includes different vitamins and minerals. The first part of an exploratory study will determine which type of BEP supplement (bar, drink, biscuit, soup or paste) is most accepted by pregnant women. Subsequently, two products will be tested for longer-term acceptability and at-home use (phase 1). The effect of the most suitable supplement will be tested in a controlled clinical trial (phase 2). The intervention group will receive the dietary supplement during pregnancy and/or lactation, while the control group complies with the standard iron and folic acid tablets following the national guidelines. IMiC will receive 600 breast milk samples from 200 dyads, 3 samples per dyad taken at 0-1, 1-2 \& 3-4 months. |
Who may qualify
- Ages
- 15 years and older
- Sex
- All
- Age groups
- Child, Adult, Older adult
- Study population
- CHILD Study: observational study of healthy term infants from Canada, Multi-ethnic (~70% Caucasian; 30% others: Asian, First Nations, Black, other) ELICIT Study: factorial RCT study design, cohorts from Haydom, Tanzania, predominantly of Black and East African descent VITAL Study: 3-arm RCT study design, cohorts from Karachi, Pakistan, predominantly of Asian descent MISAMEIII Study: 2x2 cross-over RCT study design, cohorts from Hounde District, Burkina Faso, predominantly of Black and West African descent
Key inclusion criteria (4 listed)
- 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).
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Vitamin B3Also: NicotinamideELICIT Study: Factorial design RCT of nicotinamide (vitamin B3) to mothers and infants, and antimicrobial prophylaxis (Azithromycin) to infants. | Dietary supplement | The Early Life Interventions for Childhood Growth and Development in Tanzania (ELICIT) Study |
| AzithromycinELICIT Study: Factorial design RCT of nicotinamide (vitamin B3) to mothers and infants, and antimicrobial prophylaxis (Azithromycin) to infants. VITAL Pakistan Study: 3-arm RCT of fortified food supplement (protein energy) during lactation, with or without azithromycin prophylaxis for infant. | Biological | The Early Life Interventions for Childhood Growth and Development in Tanzania (ELICIT) Study, VITAL Pakistan |
| Fortified food supplementVITAL Study: 3-arm RCT of fortified food supplement (protein energy) during lactation, with or without azithromycin prophylaxis for infant. MISAMEIII Study: 2x2 cross-over efficacy RCT of fortified food supplement (folic acid/iron +/- peanut spread) during pregnancy and/or lactation; unmasked (open label). | Dietary supplement | Micronutriments pour la Santé de la Mère et de l'Enfant (MISAME)-3 study (NCT03533712), VITAL Pakistan |
Primary outcome
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).
Time frame: This outcome is anticipated to reach completion in December 2021.
The result of this outcome will be measured by the completion of governance structure and data sharing agreements with all partners.
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.
Time frame: This outcome is anticipated to reach completion in April 2022.
The result of this outcome will be measured by the completion of all milk samples collected, stored and catalogued at MILC.
Create a standardized protocol for the comprehensive analysis of human milk composition using state-of-the-art methods in expert laboratories
Time frame: This outcome is anticipated to reach completion in December 2021.
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.
Create a harmonized dataset of human milk composition and relevant maternal, infant and environmental data from 1000 dyads
Time frame: This outcome is anticipated to reach completion in October 2023.
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.
Create an integrated analysis of this dataset
Time frame: This outcome is anticipated to reach completion in October 2023.
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
1 secondary outcome
A secondary objective of IMiC will be to support data integration across sites to answer important questions.
Time frame: This outcome is anticipated to reach completion in October 2023.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 May 2026.
- Background: PubMed 26375355Andreas NJ, Kampmann B, Mehring Le-Doare K. Human breast milk: A review on its composition and bioactivity. Early Hum Dev. 2015 Nov;91(11):629-35. doi: 10.1016/j.earlhumdev.2015.08.013. Epub 2015 Sep 12.
- Background: PubMed 23178060Ballard O, Morrow AL. Human milk composition: nutrients and bioactive factors. Pediatr Clin North Am. 2013 Feb;60(1):49-74. doi: 10.1016/j.pcl.2012.10.002.
- Background: PubMed 22513036Bode L. Human milk oligosaccharides: every baby needs a sugar mama. Glycobiology. 2012 Sep;22(9):1147-62. doi: 10.1093/glycob/cws074. Epub 2012 Apr 18.
- Background: PubMed 30247646Azad MB, Robertson B, Atakora F, Becker AB, Subbarao P, Moraes TJ, Mandhane PJ, Turvey SE, Lefebvre DL, Sears MR, Bode L. Human Milk Oligosaccharide Concentrations Are Associated with Multiple Fixed and Modifiable Maternal Characteristics, Environmental Factors, and Feeding Practices. J Nutr. 2018 Nov 1;148(11):1733-1742. doi: 10.1093/jn/nxy175.
- Background: PubMed 24500153Innis SM. Impact of maternal diet on human milk composition and neurological development of infants. Am J Clin Nutr. 2014 Mar;99(3):734S-41S. doi: 10.3945/ajcn.113.072595. Epub 2014 Feb 5.
- Background: PubMed 29846526Dror DK, Allen LH. Overview of Nutrients in Human Milk. Adv Nutr. 2018 May 1;9(suppl_1):278S-294S. doi: 10.1093/advances/nmy022.
- Background: PubMed 30723472Dawod B, Marshall JS. Cytokines and Soluble Receptors in Breast Milk as Enhancers of Oral Tolerance Development. Front Immunol. 2019 Jan 22;10:16. doi: 10.3389/fimmu.2019.00016. eCollection 2019.
- Background: PubMed 20105664Garofalo R. Cytokines in human milk. J Pediatr. 2010 Feb;156(2 Suppl):S36-40. doi: 10.1016/j.jpeds.2009.11.019.
- Background: PubMed 28788066Demmelmair H, Prell C, Timby N, Lonnerdal B. Benefits of Lactoferrin, Osteopontin and Milk Fat Globule Membranes for Infants. Nutrients. 2017 Jul 28;9(8):817. doi: 10.3390/nu9080817.
- Background: PubMed 27504516Jiang R, Lonnerdal B. Biological roles of milk osteopontin. Curr Opin Clin Nutr Metab Care. 2016 May;19(3):214-9.
- Background: PubMed 28925410Chan D, Goruk S, Becker AB, Subbarao P, Mandhane PJ, Turvey SE, Lefebvre D, Sears MR, Field CJ, Azad MB. Adiponectin, leptin and insulin in breast milk: associations with maternal characteristics and infant body composition in the first year of life. Int J Obes (Lond). 2018 Jan;42(1):36-43. doi: 10.1038/ijo.2017.189. Epub 2017 Aug 14.
- Background: PubMed 28513622Young BE, Patinkin Z, Palmer C, de la Houssaye B, Barbour LA, Hernandez T, Friedman JE, Krebs NF. Human milk insulin is related to maternal plasma insulin and BMI: but other components of human milk do not differ by BMI. Eur J Clin Nutr. 2017 Sep;71(9):1094-1100. doi: 10.1038/ejcn.2017.75. Epub 2017 May 17.
- Individual participant dataSharing planned: Yes. Data to be shared: final, annotated datasets and associated documentation (protocols, questionnaires, codebooks, data dictionaries, etc.). Data will be deposited into an open access data repository.
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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.
Meghan B Azad principal investigator
University of Manitoba, CHILD Cohort Study
Estomih Mduma study director
Haydom Lutheran Hospital, ELICIT Trial
Fyezah Jehan principal investigator
Aga Khan University Pakistan, VITAL Trial
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 Infant Growth and Maternal Health, run by University of Manitoba at 1 site in Canada.
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: under way, not looking for participants, as of the sponsor's last update on 7 May 2026. 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 Canada. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). (time frame: This outcome is anticipated to reach completion in December 2021.). The study lists 5 primary outcomes in all. 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 NCT05119166, which also lists 26 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 7 May 2026.