Clinical trials: Human Milk/Breastfeeding
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
Vitamin D Deficiency
Impact of Vitamin D Status on Bones in Breastfed Infants
Vitamin D deficiency is widespread and linked to decreased bone mineral content. Little data exists regarding the vitamin D status and the relationship of 25-hydroxyvitamin D (25-OHD) status to functional bone health outcomes in…
- Trial name
- NCT00697294
- Testing
- Tri-Vi-Sol
- Where
- 3 sites in United States
- Volunteers
- 80 people, healthy volunteers welcome
- Sponsor
- Baylor College of Medicine
Preterm Birth, Breast Milk Expression
Targeting Human Milk Fortification to Improve Preterm Infant Growth and Brain Development
This study is a randomized trial comparing 2 methods of human milk fortification for preterm infants in the neonatal intensive care unit (NICU).
- Conditions
- Preterm Birth, Breast Milk Expression, Nutrition Disorder, Infant, Brain Development Abnormality
- Trial name
- NCT03977259
- Testing
- Individually targeted fortification
- Where
- United States
- Volunteers
- 130 people
- Sponsor
- Brigham and Women's Hospital
Premature Infant, Breast Milk Expression
Growth and Nutritional Status of Very Low Birth Weight Infants Fed a High Protein Exclusive Human Milk Diet
The purpose of this two-arm investigation is to determine if growth patterns of very low birth weight infants (VLBW) (birth weight 750-1500 grams) fed human milk (maternal or donor) supplemented with a human milk-based fortifier…
- Trial name
- MedolacHMF (NCT03839173)
- Testing
- Human milk based human milk fortifier
- Where
- United States
- Volunteers
- 51 people
- Sponsor
- Augusta University
Vitamin D Deficiency, Rickets
Vitamin D Supplementation in Breastfeeding Women
Adequate vitamin D is essential for proper infant growth and development. However, human milk is low in vitamin D, and most infants do not receive recommended supplementation.
- Conditions
- Vitamin D Deficiency, Rickets, Infant Nutrition Disorders
- Trial name
- NCT01240265
- Testing
- Vitamin D3
- Where
- United States
- Volunteers
- 80 people, healthy volunteers welcome
- Sponsor
- Mayo Clinic
Preterm, Very Low Birth Weight Infant
Weight Gain in Extremely Premature Infant With Targeted Versus Adjusted Fortification
Investigation about the effect on weight gain in extremely low birth weight preterm with individualized fortification, according to human milk analysis versus fortification adjusted according to urea serum concentration.
- Conditions
- Preterm, Very Low Birth Weight Infant, Feeding, Breast, Food, Fortified
- Trial name
- FORTIN (NCT04982133)
- Testing
- Protein supplementation based on plasma urea concentration every other week or human milk analysis on experiment
- Where
- Spain
- Volunteers
- 38 people, healthy volunteers welcome
- Sponsor
- Hospital Universitario La Paz
Prematurity
Fact-based Nutrition for Infants and Lactating Mothers
Human milk (HM) is the ideal source of nutrients for infants, but its composition is highly variable. When not enough own mother's milk (OMM) is available, the administration of pasteurized donor human milk (DHM) is considered…
- Trial name
- NUTRISHIELD (NCT05646940)
- Where
- Spain
- Volunteers
- 86 people, healthy volunteers welcome
- Sponsor
- Instituto de Investigacion Sanitaria La Fe
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
Adiposity, Body Composition, Beneficial
Growth and Body Composition in Breastfed Infants - Study on Age of Introduction of Complementary Foods in Iceland
The purpose of this prospective cohort study is to investigate breast-milk and breastfeeding among infants who are exclusively and partially breastfed at 6 months of age in terms of characteristics that are hypothesised to…
- Conditions
- Adiposity, Body Composition, Beneficial, Growth Acceleration
- Trial name
- IceAge2 (NCT02586571)
- Testing
- Breastfeeding
- Volunteers
- 100 people
- Sponsor
- University of Iceland
Breast Milk Collection
Human Milk Sample Composition in Israeli Mothers and Correlation With Their Diet
The study will collect human milk from 100 mother of term infants 2-3m after delivery and from 50 mothers of preterm infants 14 and 30 days after delivery.
- Trial name
- NCT02596295
- Where
- Israel
- Volunteers
- 120 people, healthy volunteers welcome
- Sponsor
- Enzymotec
Visfatin Levels in Maternal Milk Samples, Birth Weight
Levels of Visfatin/NAMPT in Human Milk
Visfatin, released in maternal milk at different concentrations related to the maternal conditions, could act as a biomarker with a prognostic/predictive value to determine different newborn clinical conditions, particularly the…
- Trial name
- VISFAMILK (NCT06487286)
- Testing
- observational study
- Where
- Italy
- Volunteers
- 30 people
- Sponsor
- Paolo Manzoni Study Group
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
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
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
Medication Systems, Breast Feeding
The Feasibility of Drug Delivery to Infants During Breastfeeding
Parents commonly find giving medicines to babies, using oral syringes or spoons, difficult and emotionally stressful. In developing countries, additional stress arises due to hygiene difficulties and the lack of clean water.
- Conditions
- Medication Systems, Breast Feeding, Milk, Human, Infant, Newborn
- Trial name
- FEDD (NCT03799367)
- Testing
- Drug delivery during breastfeeding
- Where
- United Kingdom
- Volunteers
- 26 people
- Sponsor
- Cambridge University Hospitals NHS Foundation Trust
Necrotising Enterocolitis Neonatal
Effects of Implementation of a Care Bundle on Rates of NEC and Own Mother's Milk Feeding in the East Midlands
Necrotising enterocolitis (NEC) is a life-threatening gut disease in babies born early. Feeding preterm babies their own mother's milk prevents NEC.
- Trial name
- EMNODN-NEC (NCT05934123)
- Testing
- EMNODN NEC Care Bundle
- Where
- United Kingdom
- Volunteers
- 53,600 people
- Sponsor
- University Hospitals of Derby and Burton NHS Foundation Trust
Breastfeeding, Exclusive
Synergistic Activity of Human Milk Nutrients and Infant Cognition
Purpose: To establish a whole food, egg, as a viable study material to supplement mothers and infants with nutrients that support optimal brain development. There will be 84 breastfeeding dyads, 3 months postnatal.
- Trial name
- NCT03838536
- Testing
- Whole Egg Powder, Egg White Powder
- Where
- United States
- Volunteers
- 84 people, healthy volunteers welcome
- Sponsor
- University of North Carolina, Chapel Hill
Healthy Infants
Efficacy of Two HMOs in Chinese Infants
This is a randomized, controlled, double-blind, intervention trial of healthy male and female term infants to evaluate the efficacy of the 2 HMOs on beneficially modulating the gut microbiota, gut maturation, gut barrier…
- Trial name
- NCT06361719
- Testing
- Experimental Group (EG), Control Group (CG)
- Where
- China
- Volunteers
- 262 people, healthy volunteers welcome
- Sponsor
- Société des Produits Nestlé (SPN)
Newborns, Breast Milk Expression
Newborns Supplemented With Gentle-UHT Donor Milk
This study evaluates the effects of providing breastfeeding mothers with Gentle-UHT donor human milk (GHM) after discharge to bridge the gap during delayed onset lactation, to support an exclusive human milk diet and continued…
- Trial name
- NCT04492579
- Testing
- Gentle-UHT donor human milk supplementation
- Where
- United States
- Volunteers
- 31 people, healthy volunteers welcome
- Sponsor
- LactaLogics, Inc
Pregnancy, Lactation
The Role of Human Milk in Development of Breast Fed Child's Intestinal Microbiota
The ideal food for normal infants is human milk. In addition, breast milk has been shown to be a continuous source of commensal, and⁄or probiotic bacteria to the infant gut where they play a key role in the initiation and…
- Trial name
- MYMILK (NCT01548313)
- Where
- Slovenia
- Volunteers
- 294 people, healthy volunteers welcome
- Sponsor
- University of Ljubljana