Treatment Trials

7 Clinical Trials for Various Conditions

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ACTIVE_NOT_RECRUITING
Analysis of Donor Milk
Description

The purpose of this prospective, cross-sectional, observational study is to measure the nutrient composition of donated human breastmilk purchased from commercial human milk banks in North America

UNKNOWN
Evolutionary and Sociocultural Aspects of Human Milk Composition
Description

It is well-known that breastfeeding protects infants from illness, especially in the poorest regions of the world. The full nature of this protective effect, however, is less well understood. A major barrier to understanding is the fact that almost nothing is known about the factors that influence the considerable variation in milk composition around the globe, or about the effects of this variation on infant health. This INSPIRE project represents the first comprehensive investigation of the global differences in human milk composition along with the various microbial, evolutionary, environmental, and sociocultural factors that might influence both milk composition and infant health. An international, interdisciplinary collaboration of physiologists, nutritional scientists, anthropologists, microbiologists, and mathematicians will collect biological data from breastfeeding women and their infants, in concert with extensive anthropologic and ecological data, in both developed (US, Spain, Sweden) and developing countries (Central African Republic, Gambia, Ghana, Peru, and Kenya). To test the possibility of a correlation between milk oligosaccharide composition, milk microbiota, and the gastrointestinal microbiome of infants, milk samples and infant fecal samples will be analyzed using state-of-the-art biochemical and genomic techniques. This study will allow important cross-cultural comparisons of milk composition and infant feeding practices; it also will utilize sophisticated computational methods to integrate the extensive, diverse body of combined biological and anthropological data to elucidate the relationships among sociocultural factors, evolutionary history, environmental exposures, microbial constituents and milk composition. The researchers predict that what is considered "normal" milk composition in one population may not support optimal health in another. This information is crucial to the humanitarian quest to understand how infant nutrition and overall health can be improved around the world. In addition, this project will provide extensive research training opportunities for undergraduate, graduate and postdoctoral scientists.

RECRUITING
Human Breast Milk's Role in Food Allergy Development
Description

The goal of this prospective cohort pilot study is to learn about food allergens being passed on in breast milk to breast feeding infants. The main question\[s\] it aims to answer are: * Will major allergens for milk, egg, and peanut be passed on to infants in breast milk? * Will the infants become sensitized to and develop an allergy to the food allergens found in breast milk? * Will early introduction interventions prevent the development of these food allergies? Participants will * provide breast milk sample (s) for testing for food allergens * Infants will be tested for sensitization via skin prick and blood testing * Infants will be challenge with suspected foods to determine allergy and undergo early introduction procedures

RECRUITING
Vitamin D Sulfates in Breastmilk
Description

Infants The purpose of this study is to measure breastmilk's vitamin D sulfate nutritional value in infant's saliva and digesta (gut). Breastfeeding Mothers The purpose of this study is to measure Vitamin D sulfates in freshly expressed breastmilk samples before and after 28 days of Vitamin D supplementation in lactating mothers.

RECRUITING
Early Life Feeding Exposure and Infant Immune and Health Status.
Description

Background: Although breastfeeding has known protective effects, such as preventing childhood obesity, the specific mechanisms remain unclear. Idaho has a high breastfeeding initiation rate (92%) but a significant prevalence of childhood obesity (30.5% overweight/obese). Limited research exists on the impact of maternal inflammation, maternal body mass index (BMI), C-reactive protein (CRP), and interleukin-6 (IL-6) concentrations in breastmilk on infant health outcomes, especially in healthy full-term infants. Objective: This study aims to expand understanding of the role of maternal inflammation on breastmilk composition and its effect on infant immune development. The investigators seek to investigate the relationship between maternal health status, breastmilk inflammatory concentrations, and balanced immune development in infants. Additionally, the investigators aim to explore the potential influence of early diet exposure, including maternal inflammatory status, on the risk of obesity and other inflammatory conditions. Methods: Healthy full-term infants (breastfed/formula-fed) and their mothers will be recruited. Maternal inflammation markers (BMI, CRP, IL-6) and immune markers in infants will be analyzed. Flow cytometry will assess immune populations. Correlations between maternal systemic inflammation, infant inflammation, and breastmilk inflammatory markers will be examined for breastfeeding mothers. Outcomes: The investigators hypothesize breastfed infants will display a more favorable anti-inflammatory profile. This study will identify factors influencing immune development and potential pathways linking early-life exposures to long-term health outcomes. Findings will inform strategies for promoting balanced immune development and elucidate the role of early diet exposure, including maternal inflammation, as a protective or risk factor for obesity and inflammatory conditions.

ACTIVE_NOT_RECRUITING
Maternal Obesity, Breast Milk Composition, and Infant Growth
Description

Today the majority of pregnant women in the United States are either overweight or obese at conception with their offspring having greater adiposity at birth, a 2-fold greater risk of later obesity, and neonatal insulin resistance. It was long thought that breast milk composition was fairly uniform among women, having been optimized through evolutionary time to provide adequate sole nutrition for the growing infant regardless of the environmental circumstances. However, recent evidence shows that breast milk is a highly complex fluid with significant inter-individual variation in hormonal and cytokine concentrations. Pervasive maternal obesity is an evolutionarily novel condition for the human species but little effort has yet been made to systematically examine how this novel condition is associated with breast milk adipose-tissue derived hormone and cytokine (adipocytokine) variation, or whether that variation relates to infant metabolic status. The objective of this study is to comprehensively assess the "lactational programming" hypothesis, that is, whether or not recently documented variation in breast-milk composition is related to both maternal adiposity and to infant metabolic status. The central hypothesis is that a graded, dose-response relationship between maternal adiposity and adipocytokine concentrations in breast milk exists and that milk adipocytokine concentrations are associated with altered body composition in their exclusively breast-fed offspring. The results of the study will be used to design interventions to reduce maternal weight during pregnancy and lactation and to augment lactation education materials to focus on the needs of obese breast-feeding women.

COMPLETED
Targeted Nutrition for Moderate to Late Preterm Infants
Description

This study will be comparing the postnatal growth of moderate to late preterm infants in the Neonatal Intensive Care Unit (NICU) born between gestational ages of 30 weeks 0 days to 35 weeks and 6 days who are receiving enteral feeds of mother's own breast milk using the NICU's standard nutritional fortification protocol versus a targeted nutritional fortification protocol.