Clinical trials: Human Milk
Infant, Very Low Birth Weight
Quality Improvement Project - Evaluation of Current Standard of Care for Feeding Practices in the NICU
Human milk is associated with substantial benefits to infants' health and development, especially in premature infants. Some mothers are unable or unwilling to provide breast milk to their infant.
- Trial name
- NICU (NCT01204983)
- Where
- United States
- Volunteers
- 150 people
- Sponsor
- Baylor College of Medicine
Breastfeeding
is Dietary Manipulation of Human Milk Total Fat and Caloric Content Feasible?
The aim of this study is to verify whether dietary manipulations in lactating women allow increasing the fat and caloric content of human milk.
- Trial name
- NCT00408980
- Testing
- Fat and calorie controlled diet
- Volunteers
- 20 people, healthy volunteers welcome
- Sponsor
- Shaare Zedek Medical Center
Mastitis
Use of Probiotic Lactobacilli for the Treatment of Lactational Mastitis
A total of 300 women with lactational infectious mastitis will daily ingest 9 log10 cfu of Lactobacillus salivarius HN6, Lactobacillus reuteri CR20 or Lactobacillus fermentum LC40 for 4 weeks.
- Trial name
- NCT00716183
- Testing
- Lactobacillus salivarius HN6, Lactobacillus reuteri CR20, Lactobacillus fermentum LC40
- Where
- Spain
- Volunteers
- 300 people
- Sponsor
- Universidad Complutense de Madrid
Irritable Bowel Syndrome (IBS)
Effects of HMOs on Faecal Microbiota, Gastrointestinal Symptoms, Mucosal Immunity and Barrier Function in IBS Patients
The study is a randomised, placebo-controlled, double-blind parallel study in IBS patients. A total of 60 adult patients diagnosed with IBS-C, -D or -A/M according to Rome IV criteria will be included.
- Trial name
- NCT02875847
- Testing
- HMO1, HMO2, Dextropur
- Where
- Sweden
- Volunteers
- 60 people
- Sponsor
- Glycom A/S
Biological Availability
Stable Isotope Method to Assess Dietary Protein Quality
The evaluation of protein quality has been identified as the top priority question by the Food and Agricultural Organization (FAO) of the United Nations.
- Trial name
- NCT02966704
- Testing
- intrinsically labeled milk protein
- Volunteers
- 10 people, healthy volunteers welcome
- Sponsor
- Wageningen University
Lipid Depletion, Human Milk
Effect of Tube Feeding on LCPUFAs Delivery
Long-chain polyunsaturated fatty acids (LCPUFAs) docosahexaenoic (DHA) arachidonic acid (AA) are major building blocks for the lipid bilayer of neuronal and retinal membranes and play a crucial role in brain and visual…
- Conditions
- Lipid Depletion, Human Milk, Tube Feeding
- Trial name
- NCT03459209
- Testing
- tube feeding
- Where
- Italy
- Volunteers
- 10 people, healthy volunteers welcome
- Sponsor
- IRCCS Azienda Ospedaliero-Universitaria di Bologna
Infant, Premature, Diseases
Novel Human Milk Based Human Milk Fortifier
The primary objective is to assess weight gain of VLBW infants fed human milk supplemented with a novel human milk-based fortifier, in comparison to use of other fortifiers (historic controls).
- Trial name
- MHMHMF (NCT04478487)
- Testing
- Medolac human milk based human milk fortifier (MHMHMF)
- Where
- United States
- Volunteers
- 40 people
- Sponsor
- Northwest Health
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
Human Milk
The Influence of Storage Container and Defrost Process on Components in Breast Milk
Breast milk is best food for neonates and preterm infants. However many handling would be done if direct breastfeeding is not feasible, and it may result in nutrients change in human milk.
- Trial name
- NCT01932619
- Where
- Taiwan
- Volunteers
- 60 people, healthy volunteers welcome
- Sponsor
- Taichung Veterans General Hospital
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
Nursing Women
Effect of n-3 Polyunsaturated Fatty Acids Supplementation on Human Milk Composition of Lactating Women
We propose to measure the LCPUFA human milk (linolenic acid, linoleic acid, docosahexaenoic acid, arachidonic acid) according to fatty acids nature and quantities consumed by lactating women
- Trial name
- Oméga 3 (NCT01288313)
- Testing
- nutritional intervention
- Where
- 4 sites in France
- Volunteers
- 82 people, healthy volunteers welcome
- Sponsor
- University Hospital, Bordeaux
Preterm Birth, Breast Milk Expression
Targeting Human Milk Fortification to Improve Preterm Infant Growth and Brain Development
This study is a randomized trial comparing 2 methods of human milk fortification for preterm infants in the neonatal intensive care unit (NICU).
- Conditions
- Preterm Birth, Breast Milk Expression, Nutrition Disorder, Infant, Brain Development Abnormality
- Trial name
- NCT03977259
- Testing
- Individually targeted fortification
- Where
- United States
- Volunteers
- 130 people
- Sponsor
- Brigham and Women's Hospital
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
Sars-CoV2, Breastmilk
Is COVID-19 Transmitted Through Human Milk? Implications for Breastfeeding and Human Milk Banking-Study 1b
The Canadian Paediatric Society recommends breastfeeding during COVID-19 infection. Human milk is the best form of infant nutrition providing significant protection against many illnesses for term and preterm infants.
- Trial name
- NCT04453982
- Testing
- Human milk donors
- Where
- Canada
- Volunteers
- 384 people, healthy volunteers welcome
- Sponsor
- Deborah O'Connor
Infant, Low Birth Weight
Post Discharge Human Milk Fortifier in Preterm Infants
The purpose of this study is to determine whether low birth weight (LBW) infants fed human milk (HM)supplemented with a specially designed powdered human milk fortifier until 12 weeks after hospital discharge will have better…
- Trial name
- NCT00413985
- Testing
- Nutrient-enriched human milk
- Where
- 9 sites in Canada
- Volunteers
- 40 people
- Sponsor
- The Hospital for Sick Children
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
Acute Diarrhea
Human Milk Oligosaccharides and Childhood Diarrhoea
Assessment of the impact of oral Human Milk Oligosaccharides (HMO) application on acute diarrhoea and the development of prolonged and persistent diarrhoea in paediatric patients hospitalized with acute diarrhoea.
- Trial name
- NCT02896465
- Testing
- Oral rehydration solution, Zinc, Human milk oligosaccharides
- Where
- Bangladesh
- Volunteers
- 435 people
- Sponsor
- Société des Produits Nestlé (SPN)
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
Gut Microbiota, Gastrointestinal Symptoms
The Effects Of HMO On The Faecal Microbiota And On Gastrointestinal Symptoms In Healthy Volunteers
The study is a randomised, placebo-controlled, double-blind, parallel, dose-finding study with healthy volunteers. A total of 100 male and female volunteers will be included.
- Trial name
- HMO-VOL (NCT01927900)
- Testing
- HMO, Glucose
- Where
- Denmark
- Volunteers
- 100 people, healthy volunteers welcome
- Sponsor
- Glycom A/S
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