Clinical trials: Human Milk, Breast Milk
Infant, Premature, Diseases
Adjustable Fortification of Human Milk Fed to Chinese Preterm Infants
This clinical trial will compare how the individualized and fortified human milk feeding will help a premature infant grow.
- Trial name
- NCT01731613
- Testing
- human milk fortifier
- Where
- China
- Volunteers
- 51 people
- Sponsor
- Peking Union Medical College Hospital
Infection, Enterocolitis, Necrotizing
Oropharyngeal Administration of Mother's Colostrum for Premature Infants (NS-72393-360)
Extremely premature (BW<1250g) infants are at high risk for morbidity and mortality. Own mother's colostrum (OMC) and milk (OMM) protect against neonatal morbidity and are rich in immune factors which may provide…
- Conditions
- Infection, Enterocolitis, Necrotizing, Ventilator-associated Pneumonia
- Trial name
- NCT02116699
- Testing
- oropharyngeal mother's milk, oropharyngeal sterile water
- Where
- 5 sites in United States
- Volunteers
- 260 people
- Sponsor
- Endeavor Health
Stool Composition
Stool Composition and Stool Characteristics in Healthy Term Infants Fed Human Milk or Infant Formulas
The primary efficacy objective was to determine and compare stool composition (stool soap and non-soap fatty acids, total fatty acids, minerals, and other stool constituents) among the feeding groups.
- Trial name
- NCT01861600
- Testing
- S-26 Gold, S-26 Gold EF1, S-26 Gold EF2
- Where
- Philippines
- Volunteers
- 375 people, healthy volunteers welcome
- Sponsor
- Société des Produits Nestlé (SPN)
Prematurity
Maternal Stress, Milk Composition, and Preterm Neurodevelopment
This study explores the associations between maternal stress, breastmilk composition, and feeding and neurodevelopment for preterm infants in the NICU and at 4 months corrected age.
- Trial name
- NCT05537454
- Where
- United States
- Volunteers
- 120 people
- Sponsor
- University of Minnesota
Bioavailability and Pharmacokinetics
Silymarin Bioavailability Study
This study seeks to evaluate and compare the pharmacokinetics of a novel micellar silymarin formulation with that of a standard silymarin formulation.
- Trial name
- NCT06882681
- Testing
- LipoMicel Milk Thistle, Unformulated Milk Thistle Extract
- Where
- Canada
- Volunteers
- 16 people, healthy volunteers welcome
- Sponsor
- Isura
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
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)
NEC, Gastroschisis
Neokare Safety and Tolerability Assessment in Neonates With GI Problems
With an increasing body of evidence to support a causal link between drinking milk that contain cow's milk protein (CMP) and the development of gastrointestinal disturbance in infants, many clinicians avoid the use of CMP…
- Conditions
- NEC, Gastroschisis, Intestinal Perforation, Atresia, Intestinal
- Trial name
- NCT05293353
- Testing
- NeoKare Breast Milk Fortifier
- Where
- United Kingdom
- Volunteers
- 50 people
- Sponsor
- University Hospital Southampton NHS Foundation Trust
Immune System Diseases, Premature Infant Disease
Oral Colostrum and Its Effect on Immune System
The purpose of this project is to increase the serum immunological defenses of premature infants less then 32 weeks of gestation by administrating colostrum in the oropharyngeal mucosa versus placebo
- Conditions
- Immune System Diseases, Premature Infant Disease, Immunoglobulin Deficiency
- Trial name
- NCT03578341
- Testing
- Orally Colostrum
- Where
- 2 sites in Mexico
- Volunteers
- 96 people
- Sponsor
- Instituto Nacional de Perinatologia Isidro Espinosa de los Reyes
Study Focus: Weaning Gut Microbiota
Human Milk Oligosaccharides' Impact on Maturation of the Gut Microbiota
Human milk oligosaccharides (HMOs) are the third largest component of human milk after fat and milk sugar (lactose). HMOs play an important role in selecting the gut microbiota (GM) in newborn breastfed infants.
- Trial name
- Milkome (NCT07026526)
- Where
- Denmark
- Volunteers
- 18 people, healthy volunteers welcome
- Sponsor
- Technical University of Denmark
Obesity
Effects of HMOs on the Faecal Microbiota and on Host Metabolism in Obese Children
The study is a randomised, placebo-controlled, double-blind, parallel study in obese children. A total of 75 obese children in the age 5 to 10 years, enrolled in a childhood obesity treatment program, will be included.
- Trial name
- NCT02786160
- Testing
- HMO, Dextropur
- Where
- Denmark
- Volunteers
- 75 people
- Sponsor
- Glycom A/S
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
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
Microbial Colonization
Impact of Quinoa Milk Fermented With Lactic Acid Bacteria From Foods on Human Oral and Intestinal Flora
The demand for alternatives to dairy products has increased in recent years and a lot of proposals for vegetable milk and yogurt products have taken place in the market.
- Trial name
- NCT04280731
- Testing
- fermented quinoa
- Where
- Sweden
- Volunteers
- 20 people, healthy volunteers welcome
- Sponsor
- Lund University
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
Low-Birth-Weight Infant, Breast Feeding
Finger Feeding as a Method of HMF Supplementation After Discharge
Human Milk Fortifier (HMF) is designed to supply additional calories, protein, vitamins and minerals to infants less than 37 weeks gestation or those less than 1500 g at birth.
- Trial name
- NCT04036240
- Testing
- Finger feeding
- Where
- 4 sites in Indonesia
- Volunteers
- 78 people
- Sponsor
- Fakultas Kedokteran Universitas Indonesia
Low Birthweight Infant, Preterm
Exploring Minor Proteins and Peptides in Human Milk: a Proteomic Analysis Across Lactation Stages
Human milk (HM) is the optimal food source for the nutrition, growth, and development of newborns. The protein fraction of HM plays a crucial role in the healthy development of infants.
- Conditions
- Low Birthweight Infant, Preterm, Very Low Birth Weight Preterms
- Trial name
- PROTEOM-MILK (NCT06787963)
- Where
- 2 sites in Spain
- Volunteers
- 150 people, healthy volunteers welcome
- Sponsor
- Maimónides Biomedical Research Institute of Córdoba
Prematurity; Extreme, Failure to Thrive in Newborn
Targeted Fortification of Donor Breast Milk in Preterm Infants
This study is a randomized controlled trial comparing standard fortification of donor breast milk to targeted fortification of donor breast milk in preterm infants.
- Conditions
- Prematurity; Extreme, Failure to Thrive in Newborn, Growth Retardation, Growth Failure
- Trial name
- NCT04294368
- Testing
- Similac Human Milk Fortifier Extensively Hydrolyzed Protein Concentrated Liquid, Similac Liquid Protein Fortifier, Nestle Microlipid
- Where
- United States
- Volunteers
- 50 people
- Sponsor
- Columbia University
Breastfeeding, Exclusive
Avocado Consumption, Nutrients in Human Milk, and Infant Cognitive Development
The goal of this interventional study is to establish a whole food, avocado, as a viable study material to supplement mothers and infants with nutrients that support optimal brain development.
- Trial name
- NCT06208085
- Testing
- Avocado
- Where
- United States
- Volunteers
- 88 people, healthy volunteers welcome
- Sponsor
- University of North Carolina, Chapel Hill