- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02332382
The Influence of Mother Nutrition on Breast Milk Microbiome (Breast Milk)
The Influence of Mother Nutrition on the Composition of Fatty Acid, Oligosacharides and Its Effect on Breast Milk Microbiome
The research subject
Health organizations around the world have determined that breastfeeding is the most critical source of nutrition for newborns in the first weeks and months of their lives. A mother's breast milk contains unique nutritious components and other nonnutritive elements that help promote healthy baby growth and development (1, 2). Recent studies show that a mother's breast milk contains components that vary from each specimen. There are great evidences that maternal and environmental factors have a strong influence on the composition of breast milk. Fatty acids, the second most common component found in breast milk, show extreme sensitivity to maternal nutrition (3, 4).
Latest studies show that breast milk also contains bacterial communities that may have health implications of newborn. The structure of these bacterial communities also varied greatly between subjects (5) .
In the research, we propose to investigate the connection between maternal nutrition, different fatty acids and their role in the growth and development of bacterial populations existing in breast milk.
Study Overview
Status
Conditions
Study Type
Enrollment (Anticipated)
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
Inclusion Criteria:Healthy lactating women, breast feeding for the first 3 months after delivery
Exclusion Criteria: No compliance, sickness, drug consumption
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Study Plan
How is the study designed?
Design Details
- Observational Models: Case-Only
- Time Perspectives: Prospective
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
Change in breast milk composition in relation to nutritional intake
Time Frame: 3 months
|
3 months
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start
Primary Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- 1424-14-SMC
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Clinical Trials on Breast Milk, Composition, Microbiome
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Arkansas Children's Hospital Research InstituteCompletedEffect of Diet on Breast Milk CompositionUnited States
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James LewisNational Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)Completed
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University of Veterinary and Animal Sciences, Lahore...University of Education, Lahore; Friesland campina Engro PakistanCompletedMilk Intervention on Body Composition and School AttendancePakistan
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Sun Yat-sen UniversityCompletedComparative Nutrient Composition of Preterm and Term Human MilkChina
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Cornell UniversityNational Institute of Diabetes and Digestive and Kidney Diseases (NIDDK); United... and other collaboratorsCompletedBacterial Growth | Human Milk MicrobiomeUnited States
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University of UlsterUniversity of Leeds; ABC Nutritionals; Sensus B.V. (Royal Cosun), Roosendaal,...RecruitingBiomarkers of B-vitamin Status and Gut Microbiome CompositionUnited Kingdom
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North Carolina State UniversityActive, not recruitingImmune Cells Activity | Metabolic Health | Food Acceptance | Microbiome CompositionUnited States
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Pennington Biomedical Research CenterRecruitingEnergy Expenditure | Metabolism | Metabolic Flexibility | Infant Formula | Human Milk, Breast Milk | Infant Body Composition and MetabolismUnited States