International Milk Composition (IMiC) Consortium
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 1,000
- 试验地点
- 2
- 主要终点
- Create a harmonized dataset of human milk composition and relevant maternal, infant and environmental data from 1000 dyads
研究概览
简要总结
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.
详细描述
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).
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 15 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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).
排除标准
- •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.
研究组 & 干预措施
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.
干预措施: Vitamin B3 (Dietary Supplement)
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.
干预措施: Azithromycin (Biological)
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.
干预措施: Azithromycin (Biological)
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.
干预措施: Fortified food supplement (Dietary 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.
干预措施: Fortified food supplement (Dietary Supplement)
结局指标
主要结局
Create a harmonized dataset of human milk composition and relevant maternal, infant and environmental data from 1000 dyads
时间窗: 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 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).
时间窗: 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 standardized protocol for the comprehensive analysis of human milk composition using state-of-the-art methods in expert laboratories
时间窗: 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 an integrated analysis of this dataset
时间窗: 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
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.
时间窗: 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.
次要结局
- A secondary objective of IMiC will be to support data integration across sites to answer important questions.(This outcome is anticipated to reach completion in October 2023.)