Healthy Clinical Trial - Elucidation of Breast Milk Composition &

Status Active, not recruiting

Clinical Trial Summary

This observational study is designed to determine how sugars, lipids and proteins in breast milk vary among mothers; is affected by maternal diet, health and microbiota and vary over the course of lactation. Additionally, the study is designed to determine how the structure and composition of complex milk sugars, maternal health status and diet influence the development and maintenance of infant gut microflora.

Clinical Trial Description

This study's objectives include: 1) develop a better understanding of the composition and structures of breast milk over the early stages of lactation with specific emphasis on the glycans and lipids; 2) how glycan diversity relates to maternal and infant gut microbiota with an emphasis on bifidobacteria species; 3)how milk composition and structure relate to maternal health and diet. These samples will be analyzed using comprehensive gas and liquid chromatographic methods, nuclear magnetic resonance (NMR) spectroscopy and mass spectrometry (MS); and next generation sequencing, terminal restriction fragment length polymorphism and quantitative polymerase chain reaction. There are several cohorts to the main study. Gestational Diabetes Mellitus Cohort. The aim of this study is to investigate the differences between milk composition, infant and maternal gut microbiota from women with and without gestational diabetes mellitus or type 2 diabetes vs. controls. Fresh Milk Study. The aim of this study is to elucidate the relationship between the expression of glycan metabolizing genes of mammary epithelial cells and levels of milk glycans. RNA Study. The aim of this study is to compare the RNA of milk fat globule membrane crescents in human milk against epithelial expression profiles in non-human primate milk. Skin Study. The aim of this study is to provide skin samples from healthy term infants to act as the control group for a different study with preterm infants. Breast Milk, Gut Microbiome, and Immunity (BMMI) Project. The aim of this study is to provide healthy control samples for the BMMI project. The BMMI project is a multi-investigative project designed to elucidate how maternal nutrient status, and milk composition and structure influence infant gut microbiome from participants in developing countries. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT01817127
Study type	Observational
Source	University of California, Davis
Contact
Status	Active, not recruiting
Phase
Start date	April 1, 2009
Completion date	September 4, 2028

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Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.

Elucidation of Breast Milk Composition and Structure Over the First Year of Lactation: UC Davis Lactation Study

Clinical Trial Summary

Clinical Trial Description

Study Design

Related Conditions & MeSH terms