Clinical trials: Human Milk
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
Growth, Tolerance
Human Milk Oligosaccharides (HMOs) - Post Marketing Study on Infants (NeHMO)
Human milk oligosaccharides (HMOs) represent the third largest solid component of breast milk. Technology advancements made it possible to supplement infant formulas with HMOs (2'FL, LNnT).
- Conditions
- Growth, Tolerance, Adverse Event
- Trial name
- NCT07302477
- Testing
- HMO Supplemented Infant Formula
- Where
- 4 sites in Pakistan
- Volunteers
- 125 people, healthy volunteers welcome
- Sponsor
- Société des Produits Nestlé (SPN)
Healthy
A Study of the Impact of Different Delivery Modes on Specific Macronutrient Components in Human Milk
The aim of the study is to evaluate the impact of different delivery modes on specific macronutrient components in human milk.
- Trial name
- ZoomMING (NCT05516940)
- Where
- China
- Volunteers
- 250 people, healthy volunteers welcome
- Sponsor
- Société des Produits Nestlé (SPN)
Low-Birth-Weight Infant, Premature Infants
Analyzer of Human Milk: Applicability in Clinical Practice in Order to Achieve the Best Nutrition for Infants
An observational and prospective study involving about 30 healthy lactating mothers whose preterm infant(s) is/are hospitalized at Neonatal Intensive Care Unit after childbirth and who can provide enough maternal milk (3mL) to be…
- Trial name
- MISTU (NCT02971904)
- Testing
- human milk collection
- Volunteers
- 30 people, healthy volunteers welcome
- Sponsor
- Danone Early Life Nutrition Brazil
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
Healthy
Effect of a Multinutrient-Optimized Infant Formula Supplemented With Human Milk Oligosaccharides on Infant Growth and Development: A Multicenter, Randomized, Controlled Trial
This study aims to learn about a newly developed infant formula that adds two special ingredients found in breast milk (human milk oligosaccharides, HMOs) and improves other nutrients.
- Trial name
- NCT06569797
- Testing
- Human Milk Oligosaccharide-Supplemented, Multi-Nutrient Optimized Infant Formula, Commercially Available Standard Formula, Breast Milk Feeding
- Where
- 6 sites in China
- Volunteers
- 240 people, healthy volunteers welcome
- Sponsor
- Heilongjiang Feihe Dairy Co. Ltd.
Premature
Effect of Docosahexaenoic Acid (DHA)-Enriched Human Milk in Premature Newborns
Several recent publications showed a reduction in the level of DHA and/or an increase in the arachidonic acid (AA)/DHA ratio in the milk of mother.
- Trial name
- DHARMA (NCT01062373)
- Testing
- Supplementation of lactating mothers who has delivered prematurely with DHA
- Where
- France
- Volunteers
- 2 people, healthy volunteers welcome
- Sponsor
- Institut National de la Santé Et de la Recherche Médicale, France
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
Healthy
Intervention Study Investigating the Effect of a Phospholipid Drink on Cognitive Performance in 6-8 Year Old School Children
Six week RCT intervention on the effects of phospholipid containing milk drink vs. placebo milk drink on cognitive performance in 6-8 year old school children.
- Trial name
- NCT03705572
- Testing
- Lacprodan PL20
- Volunteers
- 165 people, healthy volunteers welcome
- Sponsor
- University of Leeds
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
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
Gastroschisis
Clinical and Biological Outcomes of Human Milk and Formula Intake After Gastroschisis Repair
The purpose of this study is to determine which type of food results in a shorter hospital stay and better overall outcome for babies born with gastroschisis.
- Trial name
- NCT02575846
- Testing
- Enteral Intake - Human Milk, Enteral Intake - Formula
- Where
- United States
- Volunteers
- 4 people, healthy volunteers welcome
- Sponsor
- Duke University
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
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)
Premature Infants
Targeted Protein Fortification in Extremely Low Birth Weight Preterm Infants
While new innovations in the care of extremely premature infants have led to decreased morbidity and mortality, poor postnatal growth remains as a major challenge.
- Trial name
- NCT02943746
- Testing
- Standard Protein Diet, High Protein Diet
- Where
- United States
- Volunteers
- 118 people, healthy volunteers welcome
- Sponsor
- Baylor College of Medicine
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