Clinical trials: Human Milk
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
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)
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)
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
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.
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)
VLBW - Very Low Birth Weight Infant
Feeding Study in VLBW Premature Infants
A multi-center, single-blind, randomized, controlled, parallel-designed, prospective trial to compare growth between preterm infants fed one of three study human milk fortifiers added to human milk
- Trial name
- NCT05744193
- Testing
- Exempt Infant Formula
- Where
- 6 sites in United States
- Volunteers
- 22 people
- Sponsor
- Mead Johnson Nutrition
Premature Infant, Low Birthweight Infant
Feeding Tolerance and Growth of Preterm Infants Consuming a Supplement Containing Two Human Milk Oligosaccharides (HMOs)
The goal of this post-market study is to describe the effect of a liquid supplement containing 2 specific human milk oligosaccharides (HMOs), 2'-fucosyllactose [2'FL] and lacto-N-neotetraose [LNnT], on feeding tolerance, growth…
- Trial name
- NCT06212427
- Testing
- HMO supplement
- Where
- 6 sites in Austria, Germany
- Volunteers
- 188 people
- 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
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
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
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)
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
Irritable Bowel Syndrome, IBS - Irritable Bowel Syndrome
Human Milk Oligosaccharides (HMOs) for Irritable Bowel Syndrome (IBS)
To assess the effects of a Human Milk Oligosaccharide mix given once daily for 12 weeks on stool consistency and abdominal pain compared to placebo in individuals with Irritable Bowel Syndrome (IBS).
- Trial name
- HIBS (NCT05205785)
- Testing
- Human Milk Oligosaccharide Mix
- Where
- Ireland
- Volunteers
- 204 people
- Sponsor
- dsm-firmenich Switzerland AG
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)
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
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.
Colic
Human Milk Oligosaccharide (HMO) Supplementation in Colic Management
Efficacy and tolerability of a composition comprising of HMO in a supplement format on colic management: a double-blind, randomized, placebo-controlled trial
- Trial name
- NCT05554991
- Testing
- HMO, Parental reassurance and support
- Where
- 7 sites in Italy, Spain
- Volunteers
- 5 people
- 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