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)
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
Breast Feeding
Human Milk Composition in Indian Mothers
Nutritional profile of mother's milk is influenced by various factors including environmental, dietary and nutritional status of the mother.
- Trial name
- NCT03061929
- Where
- 8 sites in India
- Volunteers
- 248 people, healthy volunteers welcome
- Sponsor
- Abbott Nutrition
Subjects in Need of a Human Milk Fortifier (HMF), Growth
Renoir: A Randomised, Double-blind, Controlled Trial to Evaluate the Effects of a New Human Milk Fortifier on Growth and Tolerance in Preterm Infants.
Preterm birth (birth before start of the 37th week of gestation) is a major determinant of neonatal morbidity and mortality and has long-term adverse consequences for health and neurodevelopment.
- Conditions
- Subjects in Need of a Human Milk Fortifier (HMF), Growth, Tolerance, Safety
- Trial name
- Renoir (NCT03315221)
- Testing
- Test product, Control product
- Where
- 15 sites in France, Germany and 2 more
- Volunteers
- 207 people
- Sponsor
- Nutricia Research
Weight Loss
Effects of Human Milk Oligosaccharide Ingestion on Weight Loss and Markers of Health
A randomized, double-blind, placebo-controlled, parallel arm study of 2'-fucosyllactose (2'-FL) was conducted in healthy males and females between the ages of 18 and 65 at the time of consent.
- Trial name
- HMO-RCT (NCT06547801)
- Testing
- 2'-Fucosyllactose, Maltodextrin
- Where
- United States
- Volunteers
- 60 people, healthy volunteers welcome
- Sponsor
- Advanced Protein Technologies Corporation
Growth
Preterm Infants Fed a Human Milk Fortifier
This is a double-blind, randomized, multi-center, controlled, parallel study to evaluate the growth and tolerance of preterm infants fed human milk fortifier (HMF).
- Trial name
- NCT05551975
- Testing
- Control Product, Experimental Product 1, Experimental Product 2
- Where
- 14 sites in United States
- Volunteers
- 321 people
- Sponsor
- Abbott Nutrition
Preterm Milk, Term Milk
Pre/Term Milk Profiling
This study aims for an in-depth characterization of human milk of mothers who delivered prematurely to decipher differences with milk of mothers who delivered at the expected term, with a particular focus on milk proteins
- Trial name
- NCT02052245
- Where
- Switzerland
- Volunteers
- 61 people, healthy volunteers welcome
- Sponsor
- Société des Produits Nestlé (SPN)
Aging
The Impact of a Human Breast Milk Supplement on Epigenetic and Cellular Markers
This is a trial to assess the effects of the Trulacta supplement on biological age, sleep quality, immune system and wellness markers.
- Trial name
- NCT05297097
- Testing
- Trulacta breastmilk supplement
- Where
- United States
- Volunteers
- 30 people, healthy volunteers welcome
- Sponsor
- TruDiagnostic
Healthy Diet
Detection of Gut Metabolites in Mother's Milk Following Juice Intake
The goal of the biological sample collection is to assess the presence of gut metabolites in human breast milk (BM) samples obtained prospectively from healthy lactating mothers and after consumption of fruit juice.
- Trial name
- NCT04596254
- Testing
- Pomegranate Juice
- Where
- United States
- Volunteers
- 7 people, healthy volunteers welcome
- Sponsor
- Amazentis SA
Healthy Growth
Growth and Tolerance Trial on Infant Formula With HMO
The aim of the study is to compare growth of healthy infants fed an infant formula supplemented with a human milk oligosaccharide to that of infants on standard formula.
- Trial name
- Stardust (NCT04066413)
- Testing
- Standard infant formula, Infant formula supplemented with HMO
- Where
- United States
- Volunteers
- 265 people, healthy volunteers welcome
- Sponsor
- FrieslandCampina
Protein Intolerance
Evaluation of Infants Fed an Extensively Hydrolyzed Infant Formula
This is a single group, non-randomized, multicenter study to assess the effects of a hypoallergenic casein hydrolysate powdered infant formula on gastrointestinal (GI) tolerance, growth and compliance in an intended use infant…
- Trial name
- NCT03884309
- Testing
- Experimental Hydrolyzed Protein Infant Formula
- Where
- 6 sites in United States
- Volunteers
- 48 people
- Sponsor
- Abbott Nutrition
Infant, Very Low Birth Weight
Evaluation of Prolact-Plus Human Milk Fortifier
Prolacta Bioscience has developed the first purely human fortifier, Prolact-Plus, that can provide a source of many of the required nutrients for premature, newborn infants, particularly protein and calories.
- Trial name
- NCT00486590
- Testing
- Prolact-Plus Human Milk Fortifier
- Where
- 4 sites in United States
- Volunteers
- 105 people
- Sponsor
- Prolacta Bioscience
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.
Respiratory Symptoms, Signs and Symptoms, Digestive
Evaluation of the Composition of Human Milk and Health Outcomes in Children
This study is an evaluation of the composition of human milk and health outcomes in children.
- Conditions
- Respiratory Symptoms, Signs and Symptoms, Digestive, Anemia
- Trial name
- NCT01431482
- Volunteers
- 245 people, healthy volunteers welcome
- Sponsor
- Mead Johnson Nutrition
Neonatal Abstinence Syndrome
Donor Human Milk in Neonatal Abstinence Syndrome
This study is designed to develop pilot data on the acceptability and benefit of donor human milk for infants undergoing pharmacologic treatment for NAS.
- Trial name
- DHM&NAS (NCT02182973)
- Testing
- donor human milk
- Where
- United States
- Volunteers
- 12 people
- Sponsor
- Neolac Inc dba Medolac Laboratories
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)
Cow's Milk Protein Allergy
Clinical Safety & Efficacy of a New Infant Formula With Specific Medical Purpose Containing Human Milk Oligosaccharides
The primary objective of the study is to show that infants with cow milk protein allergy (CMPA) fed with a new FSMP infant formula with reduced level of protein \& with 2 Human Milk Oligosaccharides (HMOs) (test formula) have a…
- Trial name
- CINNAMON (NCT03085134)
- Testing
- Test infant formula with HMOs, Control infant formula without HMOs
- Where
- 42 sites in Belgium, Hungary and 5 more
- Volunteers
- 194 people
- Sponsor
- Société des Produits Nestlé (SPN)
Child Development
Molecular Structure and Content of Human Milk Oligosaccharides (HMOs) and Its Effect on Infant Health in China
In the study, the composition and content of human milk oligosaccharides in premature delivery mothers in China will be examined to investigate the differences in oligosaccharide concentrations in preterm breast milk from…
- Trial name
- NCT04277260
- Where
- China
- Volunteers
- 120 people
- Sponsor
- Heilongjiang Feihe Dairy Co. Ltd.
Infant, Very Low Birth Weight
Randomized Study of Human-Milk Based Nutrition Versus Formula in Premature Infants
The purpose of this study is to determine whether very low birth weight infants (less than or equal to 1250g or about 2 3/4 pounds) born prematurely fed a diet of only human milk and human milk-derived nutrition have better…
- Trial name
- NCT00506584
- Testing
- Pasteurized human milk and pasteurized human milk fortifier, Human milk fortifier (bovine-based), pre-term formula, Pre-term/term formula
- Where
- 13 sites in United States, Austria
- Volunteers
- 260 people
- Sponsor
- Prolacta Bioscience
Clostridium Difficile Diarrhea
A Study of Safety of PBCLN-003 Following Antibiotic Therapy in Subjects With C.Difficile-associated Diarrhea
This Phase I double blind, randomized clinical study to evaluate the safety of human milk oligosaccharides (HMO) is designed to assess the safety and dosage ranging of PBCLN-003 in adults with Clostridium difficile-associated…
- Trial name
- NCT03793686
- Testing
- PBCLN-003
- Where
- United States
- Volunteers
- 26 people
- Sponsor
- Prolacta Bioscience