Clinical trials: Human Milk
Healthy
Gastrointestinal Tolerance And General Health Status Of Healthy Term Infants Fed A New Infant Formula
The purpose of this study is to assess stool consistency, in combination with additional health-related parameters including gastrointestinal tolerance and health-related quality of life, in a large sample of Chinese infants.
- Trial name
- NCT01370967
- Testing
- Study formula feeding, Human milk feeding, Mixed feeding
- Where
- 24 sites in China
- Volunteers
- 460 people, healthy volunteers welcome
- Sponsor
- Société des Produits Nestlé (SPN)
Premature Infant
Use of a Liquid Supplement Containing 2 Human Milk Oligosaccharides (HMOs) in Preterm Infants
This is a prospective, randomized, double-blind, placebo-controlled trial in preterm infants conducted at least 4 centers in France, consisting of 2 parallel groups.
- Trial name
- NCT03607942
- Testing
- HMO supplement
- Where
- 7 sites in France
- Volunteers
- 86 people
- Sponsor
- Société des Produits Nestlé (SPN)
Healthy
Clinical Safety of a New Infant Starter Formula Containing 2 Human Milk Oligosaccharides (HMOs)
The primary objective of this clinical study is to show that infants fed a standard starter infant formula with 2 Human Milk Oligosaccharides (HMOs) have a growth in line with infants fed a standard starter infant formula without…
- Trial name
- NCT01715246
- Testing
- Infant Formula
- Where
- 2 sites in Belgium, Italy
- Volunteers
- 176 people, healthy volunteers welcome
- Sponsor
- Société des Produits Nestlé (SPN)
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
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 Volunteers
Milk Free From A1-Type β-Casein With Human Milk Oligosaccharides on Gut Health, Immunity, Cognitive Development, and Temperament in Toddlers
The aim of the study is to compare the effects of HMOs in A1-type β-casein-free formula on gut health, immunity, inflammation, gut microflora, cognitive development, and temperament compared with HMOs in conventional formula in…
- Trial name
- NCT07882043
- Testing
- a2 toddler milk with HMOs, Conventional toddler milk with HMOs
- Where
- China
- Volunteers
- 80 people, healthy volunteers welcome
- Sponsor
- a2 Milk Company Ltd.
Cognitive Change
Improved Cognitive Outcomes Associated With Feihe HMO With DHA/ARA in Infant Formula
The goal of this interventional clinical trial is to test the effectiveness of improving cognitive development in newly born infants fed with Feihe investigational formula product containing HMO, and DHA/ARA.
- Trial name
- NCT06146387
- Testing
- Investigational Formula, Control Formula, Breastfeeding
- Where
- 3 sites in China
- Volunteers
- 240 people, healthy volunteers welcome
- Sponsor
- Heilongjiang Feihe Dairy Co. Ltd.
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)
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
Iron Absorption
Iron Absorption From an Iron-fortified Follow-up Formula With Added Synbiotic or Human Milk Oligosaccharides
The co-primary objectives of this study are: 1) to investigate the effect adding a synbiotic (combination of a pre-and probiotic) to iron-fortified follow-up formula (FUF) on iron bioavailability, and 2) to investigate the effect…
- Trial name
- NCT04774016
- Testing
- Test formula A without added pre- and pro-biotic, Test formula B with synbiotic, Test formula C with HMOs
- Where
- Thailand
- Volunteers
- 82 people, healthy volunteers welcome
- Sponsor
- Société des Produits Nestlé (SPN)
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
Infant Growth
Evaluation of Human Milk Fortifiers in Preterm Infants
The purpose of this study is to assess growth of preterm infants fed human milk supplemented with one of two commercially available human milk fortifiers.
- Trial name
- NCT02307760
- Testing
- Human Milk Fortifier A, Human Milk Fortifier B
- Where
- 18 sites in United States
- Volunteers
- 164 people
- Sponsor
- Abbott Nutrition
Immunization, Human Influenza
Study of Yili Lactoferrin ShuHua Milk in the Improvement of Human Immunization
The purpose of this study is to determine whether Yili Lactoferrin ShuHua Milk are effective in reducing the occurrence of flu symptoms.
- Conditions
- Immunization, Human Influenza, Common Cold
- Trial name
- NCT01677702
- Testing
- Yili Lactoferrin ShuHua Milk (Lactoferrin 5mg/100ml), Yili Lactoferrin ShuHua Milk (Lactoferrin 10mg/100ml), Recombined low protein milk
- Where
- 2 sites in China
- Volunteers
- 240 people, healthy volunteers welcome
- Sponsor
- Inner Mongolia Yili Industrial Group Co., Ltd
Healthy Infants
The Trial of a New Infant Formula in Healthy Term Chinese Infants
The aim of this randomized, controlled, multi-center, double-blind study of healthy term infants is to test the safety and efficacy of a new infant formula with a specific blend of six human milk oligosaccharides.
- Trial name
- HexaHMO (NCT06053112)
- Testing
- New infant formula with 6 HMOs blend, Standard infant formula without 6 HMOs blend
- Where
- 5 sites in China
- Volunteers
- 326 people, healthy volunteers welcome
- Sponsor
- Junlebao Dairy Group Co., Ltd.
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.
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
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)
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
Cow Milk Allergy
Growth of Infants With Cow's Milk Allergy Fed an Amino Acid-based Formula Containing Two Human Milk Oligosaccharides
The main aim of this study is to provide longitudinal growth data in infants with moderate-to-severe cow's milk allergy fed an amino acid-based formula with two added human milk oligosaccharides.
- Trial name
- PLATYPUS (NCT03661736)
- Testing
- Food for Specific Medical Purpose
- Where
- Australia
- Volunteers
- 33 people, healthy volunteers welcome
- Sponsor
- Société des Produits Nestlé (SPN)
Healthy Infants
Second Generation Human Milk Oligosaccharides Blend Study
The aim of this trial is to show that infants fed these new formulas, containing a blend of 5 Human Milk Oligosaccharides (HMOs), allow for growth in line with infants fed formulas without HMOs.
- Trial name
- NCT03722550
- Testing
- Starter Infant Formula, Follow-up Formula, and Growing-up Milk Supplemented With a Blend of Five Human Milk Oligosaccharides, Breast-feeding, Standard Starter Infant Formula, Follow-up Formula, and Growing-up Milk
- Where
- 34 sites in Bulgaria, Hungary and 1 more
- Volunteers
- 789 people, healthy volunteers welcome
- Sponsor
- Société des Produits Nestlé (SPN)