Clinical trials: Human Milk/Breastfeeding
Breastmilk, Breastmilk Expression
Comparison of Macronutrient Content of Breast Milk Collected From Mothers Using Three Different Milking Methods
The aim of this study is to compare the macronutrient content of mature milk obtained from mothers using three different methods: hand milking, manual pumping and electric machine.
- Conditions
- Breastmilk, Breastmilk Expression, Breastmilk Collection, Human Milk/Breastfeeding
- Trial name
- NCT07046962
- Testing
- Intervention Type Device: Manual pump expressing breast milk, Intervention Type Device: Hand pumping breast milk, Intervention Type Device: Electric pumping breast milk
- Where
- Turkey (Türkiye)
- Volunteers
- 31 people, healthy volunteers welcome
- Sponsor
- Sakarya University
Mastitis
Use of Probiotic Lactobacilli for the Treatment of Lactational Mastitis
A total of 300 women with lactational infectious mastitis will daily ingest 9 log10 cfu of Lactobacillus salivarius HN6, Lactobacillus reuteri CR20 or Lactobacillus fermentum LC40 for 4 weeks.
- Trial name
- NCT00716183
- Testing
- Lactobacillus salivarius HN6, Lactobacillus reuteri CR20, Lactobacillus fermentum LC40
- Where
- Spain
- Volunteers
- 300 people
- Sponsor
- Universidad Complutense de Madrid
Breast Feeding
eHealth for Breastfeeding Support - the HOTSPOT Trial
This is a voluntary research study to test use of a phone app that is intended to support breastfeeding specifically for African American and Black people. This is called a "pilot" study because the app is still in development.
- Trial name
- NCT06378320
- Testing
- App access and Text message, App access only
- Where
- 3 sites in United States
- Volunteers
- 20 people, healthy volunteers welcome
- Sponsor
- University Hospitals Cleveland Medical Center
Breastfeeding
Gestational Diabetes and Antenatal Human Milk Expression
Exclusive breastfeeding is global recognized as the optimal infant feeding. Hong Kong is committed to promoting, protecting and supporting the global movement for successful breastfeeding.
- Trial name
- NCT05851651
- Testing
- Antenatal milk expression and breastfeeding self-efficacy enhancement
- Where
- 2 sites in Hong Kong
- Volunteers
- 246 people
- Sponsor
- The University of Hong Kong
Neonatal Hypoglycemia, Metabolic Complication
Pasteurised Donor Human Milk Supplementation for Term Babies
PRESENT is a multi-center randomised controlled trial that aims to assess whether access to pasteurized donor human milk as supplementary nutrition in the first five days of life for term infants born to women with diabetes in…
- Conditions
- Neonatal Hypoglycemia, Metabolic Complication, Cows Milk Allergy, Hospital Length of Stay
- Trial name
- PRESENT (NCT06993103)
- Testing
- Standard care Cow's milk based formula, Dietary Supplement: PDHM Pasteurised Donor Human Milk
- Where
- 4 sites in Australia
- Volunteers
- 1,444 people
- Sponsor
- The University of Queensland
Healthy, Gestational Diabetes Mellitus
Elucidation of Breast Milk Composition and Structure Over the First Year of Lactation: UC Davis Lactation Study
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.
- Conditions
- Healthy, Gestational Diabetes Mellitus, Type 2 Diabetes Mellitus
- Trial name
- NCT01817127
- Where
- United States
- Volunteers
- 395 people, healthy volunteers welcome
- Sponsor
- University of California, Davis
Neonatal Hypoglycemia
Effectiveness of Donor Human Milk Supplementation for the Treatment of Hypoglycemia in the Breastfed Infant
The purpose of this study is to compare if newborn infant hypoglycemia can be improved with bottle supplementation of commercially-sterilized donor human milk compared to standard infant formula.
- Trial name
- NCT04030312
- Testing
- Bottle Supplementation--Commercially-Sterilized Donor Human Milk, Bottle Supplementation--Standard Infant Formula
- Where
- United States
- Volunteers
- 18 people, healthy volunteers welcome
- Sponsor
- University of Nebraska
Prematurity
Human Milk Cream as a Caloric Supplement in Pre-Term Infants
Human milk is commonly considered to have 20 calories per ounce (kcal/oz). However, studies show that up to 65% of human milk may be less than the expected 20 kcal/oz which can greatly affect an infant's growth.
- Trial name
- NCT01487928
- Testing
- Human Milk Cream
- Where
- 2 sites in United States
- Volunteers
- 78 people
- Sponsor
- Baylor College of Medicine
Human Milk Nutrient Reference Values
Establishing Global Reference Values for Human Milk
The primary purpose of the proposed research is to establish Reference Values (RVs) for micronutrients (MN) and macronutrients in human milk.
- Trial name
- MILQ (NCT03254329)
- Testing
- Assessment of human milk nutrient composition
- Where
- 4 sites in Bangladesh, Brazil and 2 more
- Volunteers
- 2,000 people, healthy volunteers welcome
- Sponsor
- USDA, Western Human Nutrition Research Center
Breastfeeding, Dietary Intervention
Effect of Prenatal and Postnatal Intervention Strategies on Breastfeeding Outcomes in Women With Excessive Weight (Ready, Set, Nourish Study)
This study is about preparing women with excessive weight to have better breastfeeding outcomes. By doing this study, the investigators hope to learn more about how hand expression of breast milk or colostrum during pregnancy can…
- Conditions
- Breastfeeding, Dietary Intervention, Milk Expression, Breast
- Trial name
- RSN (NCT06929091)
- Testing
- Lactation Support and ABME, Lactation Support and meal plan, Lactation Support
- Where
- United States
- Volunteers
- 240 people
- Sponsor
- Arkansas Children's Hospital Research Institute
Breast Milk Collection, Human Milk/Breastfeeding
Human Milk and Its Effect on Infant's Metabolism and Infant Gut Microbiome
This protocol explains the MAINHEALTH cohort. The study examine the influence of maternal health parameters on human breast milk composition and integrates milk phenotype with infant metabolism and infant gut microbial content…
- Conditions
- Breast Milk Collection, Human Milk/Breastfeeding, Human Milk Microbiome, Infant Gut Microbiome
- Trial name
- MAINHEALTH (NCT05111990)
- Where
- Denmark
- Volunteers
- 168 people, healthy volunteers welcome
- Sponsor
- University of Aarhus
Breastmilk Collection, Micronutrients
Breastmilk as a Source of Lactocytes
The objective of this study is to determine the suitability of lactocytes derived from human breast milk for gene expression analysis, and to explore whether there are any correlations between gene expression and the…
- Trial name
- NCT05857345
- Testing
- Collection of breastmilk
- Where
- Germany
- Volunteers
- 10 people, healthy volunteers welcome
- Sponsor
- University of Hohenheim
Breast Milk Collection
Factors Influencing the Composition of Human Milk
This study aims for characterization of different maternal, infant and environmental factors (e.g. maternal age, pregnancy duration, lactation period, baby gender, circadian rhythm, Holder pasteurisation, etc.) that influence…
- Trial name
- NCT04382989
- Testing
- Analysis of human milk composition by mid-infrared spectrophotometry
- Where
- Lithuania
- Volunteers
- 174 people, healthy volunteers welcome
- Sponsor
- Vilnius University
Breast Milk Collection
the Study of Persistent Organic Pollutants in Human Milk
The study aims to recruit eligible participants and conduct interviews, collect human milk samples, and conduct laboratory analysis of persistent organic pollutants' levels in human milk samples.
- Trial name
- NCT04102085
- Testing
- no intervention
- Where
- Hong Kong
- Volunteers
- 50 people, healthy volunteers welcome
- Sponsor
- Chinese University of Hong Kong
Food Allergy in Infants, Food Allergen Sensitisation
Human Breast Milk's Role in Food Allergy Development
The goal of this prospective cohort pilot study is to learn about food allergens being passed on in breast milk to breast feeding infants.
- Conditions
- Food Allergy in Infants, Food Allergen Sensitisation, Breast Feeding, Exclusive, Breastmilk Collection
- Trial name
- NCT06765213
- Testing
- Open Ended Oral Food Challenge, Early Introduction
- Volunteers
- healthy volunteers welcome
- Sponsor
- The University of Texas Medical Branch, Galveston
Microbial Colonization
Comparing Impacts of Donor Human Milk to Formula Supplementation on the Gut Microbiome of Full-term Infants
The goal of this pilot randomized controlled trial (RCT) is to examine donor human milk (DHM) as a clinical intervention targeted at achieving beneficial microbiome signatures in full-term infants who are exposed to intrapartum…
- Trial name
- PPDHM (NCT05815433)
- Testing
- Donor Human Milk - Nutritional Replacement
- Where
- Canada
- Volunteers
- 105 people, healthy volunteers welcome
- Sponsor
- University of Calgary
HIV, Infant Morbidity
Mitigating Infectious Morbidity and Growth Deficits in HIV Exposed Uninfected infanTs With Human Milk Oligosaccharides
Primary Objective: To evaluate the effects of synbiotics on infectious morbidity and growth while it is in place from 4 to 24 weeks of age.
- Conditions
- HIV, Infant Morbidity, Breast Feeding
- Trial name
- MIGH-T MO (NCT05282485)
- Testing
- Synbiotic, Maltodextrin
- Where
- South Africa
- Volunteers
- 140 people, healthy volunteers welcome
- Sponsor
- Columbia University
Sars-CoV2, Breastmilk
Is COVID-19 Transmitted Through Human Milk? Implications for Breastfeeding and Human Milk Banking-Study 1b
The Canadian Paediatric Society recommends breastfeeding during COVID-19 infection. Human milk is the best form of infant nutrition providing significant protection against many illnesses for term and preterm infants.
- Trial name
- NCT04453982
- Testing
- Human milk donors
- Where
- Canada
- Volunteers
- 384 people, healthy volunteers welcome
- Sponsor
- Deborah O'Connor
Breastfeeding, Exclusive, Breastfeeding
Donor Breast Milk and Breastfeeding Rates
The purpose of this pilot study is to determine if a randomized controlled study comparing a human milk diet versus a formula supplemented diet in late preterm and term infants in the neonatal intensive care unit (NICU) is…
- Trial name
- NCT04572581
- Testing
- Donor Breast Milk
- Where
- 2 sites in United States
- Volunteers
- 32 people
- Sponsor
- University of California, Los Angeles
Breast Milk Collection, Nutrition Disorder, Infant
Analysis of Donor Milk
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
- Trial name
- DOME (NCT05742815)
- Testing
- No intervention
- Where
- United States
- Volunteers
- 20 people
- Sponsor
- Augusta University