Clinical trials: Human Milk
Allergy
Acceptability and Palatability Study of Paediatric Amino Acid Feed
Product acceptability and palatability data from a minimum of 15 participants are required to submit an application to the Advisory Committee on Borderline Substances (ACBS) and the Health Service Executive (HSE) for Ireland for…
- Trial name
- NCT06547346
- Testing
- Alfamino Junior
- Where
- United Kingdom
- Volunteers
- 15 people
- Sponsor
- Société des Produits Nestlé (SPN)
VLBW - Very Low Birth Weight Infant
Feeding Study in VLBW Premature Infants
A multi-center, single-blind, randomized, controlled, parallel-designed, prospective trial to compare growth between preterm infants fed one of three study human milk fortifiers added to human milk
- Trial name
- NCT05744193
- Testing
- Exempt Infant Formula
- Where
- 6 sites in United States
- Volunteers
- 22 people
- Sponsor
- Mead Johnson Nutrition
Premature Infant
Effect of Increased Enteral Protein on Body Composition of Preterm Infants
The study hypothesis is that, in human milk-fed extremely preterm infants, higher protein intake compared to usual protein intake reduces percent body fat (%BF) at 3 months of age.
- Trial name
- NCT03586102
- Testing
- High protein supplementation, Standard protein supplementation
- Where
- United States
- Volunteers
- 56 people
- Sponsor
- University of Alabama at Birmingham
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
Human Milk, Premature Birth of Newborn
Noninferiority Trial of Liquid Human Milk Fortifier (HMF) Hydrolyzed Protein Versus Liquid HMF With Supplemental Liquid Protein
Breast milk is readily accepted as the ideal source of nutrition for almost all infants, including premature or very low birth weight infants.
- Trial name
- NCT03001479
- Testing
- Similac Human Milk Fortifier Hydrolyzed Protein Concentrated Liquid
- Where
- United States
- Volunteers
- 78 people
- Sponsor
- St. Louis University
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
Replacement Therapy in Preterm Infants
Efficacy and Safety of Bile Salt Stimulated Lipase (BSSL) as Replacement Therapy in Infant Formula for Preterm Infants
The purpose of this study is to evaluate the efficacy in preterm infants following treatment with BSSL when administered in infant formula.
- Trial name
- NCT00658905
- Testing
- rhBSSL
- Where
- 6 sites in Italy
- Volunteers
- 33 people
- Sponsor
- Swedish Orphan Biovitrum
Preterm Infant, Feeding Disorder Neonatal
Oropharyngeal Administration of Mother's Milk in Preterm Infants and Gastrointestinal Motility
Mother's milk does not come in contact with the oropharyngeal pouch of preterm infants during gavage feeding. We hypothesized that stimulation of the oropharyngeal pouch using small amount of the mother's milk 5 minutes before…
- Conditions
- Preterm Infant, Feeding Disorder Neonatal, Gastrointestinal Motility Disorder
- Trial name
- OPAMM (NCT03552510)
- Testing
- Oro-pharyngeal Administration of Mother's Milk
- Where
- Egypt
- Volunteers
- 20 people
- Sponsor
- Mansoura University Children Hospital
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
Diabetes Mellitus, Type1diabetes
The Effect of Human Milk Oligosaccharides in Children With Type 1 Diabetes Mellitus
Type 1 diabetes mellitus (DM) is an autoimmune disease characterized by absolute insulin deficiency, defined as insulin-dependent diabetes mellitus and develops due to autoimmune damage of beta cells in the pancreas.
- Trial name
- NCT05521061
- Testing
- 2-fucosyllactose
- Where
- Turkey (Türkiye)
- Volunteers
- 111 people
- Sponsor
- Ege University
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
Neonatal Abstinence Syndrome
Clinical Trial to Decrease Length of Stay in Infants With Neonatal Abstinence Syndrome With an Exclusive Human Milk Diet
A clinical trial to evaluate length of stay, growth velocity and clinical outcomes in infants with neonatal abstinence syndrome receiving an exclusive human milk diet.
- Trial name
- NCT04508348
- Testing
- Human Milk, Standard of Care
- Where
- 2 sites in United States
- Volunteers
- 19 people
- Sponsor
- The University of Texas Health Science Center at San Antonio
Respiratory Infections
Role of Human Milk Bank in the Protection of Severe Respiratory Disease in Very Low Birth Weight Premature Infants
Acute respiratory infections are the leading cause of hospitalization in premature infants worldwide. Severity rates are particularly high in developing countries.
- Trial name
- NCT01390753
- Testing
- Human donor milk
- Where
- Argentina
- Volunteers
- 300 people
- Sponsor
- Fundacion Infant
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
Prematurity
Milk And Growth In Children (MAGIC) Born Very Preterm: A Randomized Trial
The goal of this multi-center randomized, parallel group trial is to determine the effect of human milk diets ranging between 180 and 200 mL/kg/day on the body composition outcomes of moderately preterm infants born between 27…
- Trial name
- MAGIC (NCT06420531)
- Testing
- Human milk
- Where
- 4 sites in United States
- Volunteers
- 486 people
- Sponsor
- University of Alabama at Birmingham
Hepatitis B, Tenofovir
Tenofovir in Pregnancy to Prevent Mother to Child Transmission of Hepatitis B.
Hepatitis B virus (HBV) can be asymptomatic for years but can also lead to chronic hepatitis, hepatocellular carcinoma, and liver failure and death and cannot be eradicated with the current therapy.
- Conditions
- Hepatitis B, Tenofovir, Pregnancy
- Trial name
- PK-TDF (NCT04114890)
- Testing
- Tenofovir Disoproxil Fumarate
- Where
- Thailand
- Volunteers
- 27 people
- Sponsor
- University of Oxford
Human Milk Nutrition
Determinants of the Nutritional Composition of Donor Human Milk
Human milk is the most complete and correct way to feed a newborn, as it provides all the nutrients and bioactive factors essential for adequate growth and neurodevelopment.
- Trial name
- NCT06904924
- Where
- Portugal
- Volunteers
- 80 people
- Sponsor
- Universidade do Porto