Clinical trials: Human Milk
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
Healthy
Safety Study of Human Milk Oligosaccharides in Healthy Adults
First-in-human phase 1 study conducted in healthy adult male and female volunteers to determine the safety and tolerability of increasing doses of PBCLN-003, which are concentrated human milk oligosaccharides (HMO).
- Trial name
- NCT05516225
- Testing
- PBCLN-003
- Where
- United States
- Volunteers
- 32 people, healthy volunteers welcome
- Sponsor
- Prolacta Bioscience
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)
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
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
Infant Nutrition
Study Evaluating Growth and Tolerance of Infant Formula Containing HMOs
The primary objective of this clinical study is to investigate the suitability of an infant formula containing five different human milk oligosaccharides to support normal physical growth (evaluated per weight gain), in…
- Trial name
- NCT03513744
- Testing
- human milk oligosaccharides
- Where
- 9 sites in Germany, Italy and 1 more
- Volunteers
- 340 people, healthy volunteers welcome
- Sponsor
- Jennewein Biotechnologie GmbH
Healthy Infants
Efficacy of Two HMOs in Chinese Infants
This is a randomized, controlled, double-blind, intervention trial of healthy male and female term infants to evaluate the efficacy of the 2 HMOs on beneficially modulating the gut microbiota, gut maturation, gut barrier…
- Trial name
- NCT06361719
- Testing
- Experimental Group (EG), Control Group (CG)
- Where
- China
- Volunteers
- 262 people, healthy volunteers welcome
- Sponsor
- Société des Produits Nestlé (SPN)
Hypercholesterolemia
The Effect of Shuhua Milk Fortified With Plant Sterol Esters on Serum Cholesterol in Human
The purpose of this study is to determine whether YiLi Xinhuo Shuhua Milk is effective in reducing the serum cholesterol in human with hypercholesterolemia.
- Trial name
- NCT02475018
- Testing
- Milk fortified with plant sterol esters, Plain milk
- Where
- China
- Volunteers
- 179 people
- Sponsor
- Inner Mongolia Yili Industrial Group Co., Ltd
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
Infectious Diseases, Healthy Subjects
Effect of the Consumption of a Fermented Milk on Common Infections in Shift-workers
This single-center, randomized, double-blind and controlled study aims to examine the effect of a fermented dairy product containing the probiotic Lactobacillus casei DN-114 001 (Actimel® = tested product) on the incidence of…
- Conditions
- Infectious Diseases, Healthy Subjects, Respiratory Tract Infections, Sore Throat
- Trial name
- NCT01033799
- Testing
- Fermented dairy product containing the probiotic Lactobacillus casei DN-114 001 (Actimel®), Non fermented dairy product (control)
- Where
- Germany
- Volunteers
- 1,000 people, healthy volunteers welcome
- Sponsor
- Danone Global Research & Innovation Center
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.
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.
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)
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
Low Birth Weight Infants
The Influence by Dietary Human Milk Oligosaccharide in Low Birth Weight Infants
This study aims to investigate the concentration of various growth factors and cytokines in blood, and to examine the gut microbiota of low birth weight infants fed with formulas with or without Human Milk Oligosaccharide (HMO)…
- Trial name
- NCT05203900
- Testing
- Infant formula with Human Milk Oligosaccharide, Infant formula without Human Milk Oligosaccharide
- Where
- Thailand
- Volunteers
- 60 people
- Sponsor
- Meiji Co., Ltd.
Breast Milk Collection
Odour Characteristics of Human Breast Milk of Chinese Mothers
It is well known that breast milk exerts many positive effects on the general health, growth and development of infants. When breastfeeding is not possible, infant formula is considered to be an effective substitute to satisfy…
- Trial name
- NCT05133466
- Where
- China
- Volunteers
- 90 people, healthy volunteers welcome
- Sponsor
- Heilongjiang Feihe Dairy Co. Ltd.
Breast Milk
Human Milk Profiles and Dietary Intake of Chinese Lactating Mothers During Early Lactation Period in Shanghai
This study aims to investigate breast milk composition and dietary habits of Chinese lactating mothers. Further understanding of the composition of human milk will help to understand the nutritional needs of mothers and their…
- Trial name
- MuRu (NCT02070562)
- Where
- China
- Volunteers
- 120 people, healthy volunteers welcome
- Sponsor
- Dumex Baby Food Co., Ltd.
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)
Growth, Tolerance
Human Milk Oligosaccharides (HMOs) Post-market 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, Disorder of Intestine
- Trial name
- NeHMO DACH (NCT05150288)
- Testing
- HMO-supplemented infant formula
- Where
- 17 sites in Austria, Germany and 1 more
- Volunteers
- 106 people, healthy volunteers welcome
- Sponsor
- Société des Produits Nestlé (SPN)
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