Clinical trials: Human Milk, Breast Milk
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.
Body Weight, Obesity & Overweight
Breastmilk and the Link to Overweight/Obesity and Maternal Diet in the Mother-breastmilk-child Triad
The prospective 5-month follow-up study will involve 150 mother-infant dyads grouped based on maternal baseline BMI category (normal weight, overweight, obesity).
- Conditions
- Body Weight, Obesity & Overweight, Human Milk/Breastfeeding, Body Composition
- Trial name
- BLOOM-Triad (NCT07457515)
- Where
- 4 sites in Canada, Poland
- Volunteers
- 165 people, healthy volunteers welcome
- Sponsor
- Warsaw University of Life Sciences
Neurodevelopmental Outcomes of VLBW Infants
Donor Human Milk and Neurodevelopmental Outcomes in Very Low Birthweight (VLBW) Infants
Breastfeeding is an important health-promoting behavior. Human milk is the ideal diet for all infants, optimizes intellect, and provides protection against infectious and atopic diseases in childhood as well as decreasing risks…
- Trial name
- NCT01232725
- Testing
- Donor Human Milk
- Where
- United States
- Volunteers
- 121 people
- Sponsor
- Tarah T Colaizy
PreTerm Birth, Human Milk
Protein Balance and Body Composition in Preterm Infants
The adequacy of the quality of protein supply could influence the rate and the relative composition of weight gain in very low birth weight preterm infants.
- Trial name
- NCT03013374
- Where
- Italy
- Volunteers
- 30 people
- Sponsor
- Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico
Docosahexaenoic Acid Content of the Participants, Docosahexaenoic Acid Content of the Breast Milk
Effectiveness of Nutritional Resources for Milk Donors
Maternal diet influences breast milk nutritional profile; however, a national survey undertaken by the researchers revealed that non-for-profit donor milk banks in the U.K. do not provide specific dietary information to donors.
- Trial name
- VITAMIN (NCT07042009)
- Testing
- Nutritional resources, Milk docosahexaenoic acid levels
- Where
- United Kingdom
- Volunteers
- 60 people, healthy volunteers welcome
- Sponsor
- University of Roehampton
Lactation
Growth Hormones and Cells in Human Milk Depending on Gestational Age
Human breast milk contains growth factors including neurotrophins and cells with neuroprotective potential. Concerning growth factors milk of preterms differs significantly from term milk.
- Trial name
- BMProfile (NCT02662517)
- Where
- Germany
- Volunteers
- 43 people, healthy volunteers welcome
- Sponsor
- University Hospital of Cologne
Sports Nutrition, Protein Supplementation
Acute Whey Protein And Casein Supplementation: Effect On Protein Metabolism After Resistance Exercise
The proteins of human breast milk are the most important endocrine signaling system that promotes neonatal growth by increasing the release of insulin, insulin-like growth factor-1 (IGF-1), and the leucine-mediated mammalian…
- Trial name
- NCT04648384
- Testing
- Blend Protein Supplementation, Resistance Exercise
- Where
- Brazil
- Volunteers
- 10 people, healthy volunteers welcome
- Sponsor
- University of Sao Paulo
Breast Feeding
Human Milk Composition in Indian Mothers
Nutritional profile of mother's milk is influenced by various factors including environmental, dietary and nutritional status of the mother.
- Trial name
- NCT03061929
- Where
- 8 sites in India
- Volunteers
- 248 people, healthy volunteers welcome
- Sponsor
- Abbott Nutrition
Pregnancy, Physical Activity
Effect of Physical Activity in Pregnancy on Maternal and Fetal Human Milk Oligosaccharides: a Pilot Study
This prospective observational study investigates the interaction of maternal physical activity (PA) and body composition during pregnancy with prenatal Human Milk Oligosaccharide (HMO) concentrations, and assesses associations…
- Trial name
- NCT05496712
- Where
- Austria
- Volunteers
- 230 people, healthy volunteers welcome
- Sponsor
- Medical University of Graz
Infant, Premature, Diseases
Multisensory Early Oral Administration of Human Milk (M-MILK) for Very Preterm Infants
The goal of this clinical trial is to learn if the multisensory early oral administration of human milk (M-MILK) intervention helps infants who are born younger than 32 weeks gestational age (very preterm infants).
- Trial name
- M-MILK RCT (NCT07216664)
- Testing
- Multisensory early oral administration of human milk
- Where
- 2 sites in United States
- Volunteers
- 125 people
- Sponsor
- Loyola University
Premature Infant
Effect of Increased Enteral Protein on Body Composition of Preterm Infants
The study hypothesis is that, in human milk-fed extremely preterm infants, higher protein intake compared to usual protein intake reduces percent body fat (%BF) at 3 months of age.
- Trial name
- NCT03586102
- Testing
- High protein supplementation, Standard protein supplementation
- Where
- United States
- Volunteers
- 56 people
- Sponsor
- University of Alabama at Birmingham
Preterm Infants
Protocol-driven Nutrition in Preterm Infants
The project is a national, prospective, multicenter, interventional pilot project focused on protocol-driven nutrition in preterm infants in the Czech republic.
- Trial name
- NCT07364500
- Testing
- Nutrition plan supported by advanced clinical nutrition software
- Where
- 5 sites in Czechia
- Volunteers
- 400 people
- Sponsor
- Institute of Health Information and Statistics of the Czech Republic
Healthy Volunteers
Human Milk Oligosaccharide-Based Synbiotic Supplement for Intestinal Microbiota Dysbiosis
Background: Human intestines are home to a complex gut flora, also called microbiome; this is a natural occurring community of bacteria, fungi, yeast, and viruses.
- Trial name
- NCT06615986
- Testing
- Cardiosyn
- Where
- United States
- Volunteers
- 46 people
- Sponsor
- National Heart, Lung, and Blood Institute (NHLBI)
Healthy, Gestational Diabetes Mellitus
Elucidation of Breast Milk Composition and Structure Over the First Year of Lactation: UC Davis Lactation Study
This observational study is designed to determine how sugars, lipids and proteins in breast milk vary among mothers; is affected by maternal diet, health and microbiota and vary over the course of lactation.
- Conditions
- Healthy, Gestational Diabetes Mellitus, Type 2 Diabetes Mellitus
- Trial name
- NCT01817127
- Where
- United States
- Volunteers
- 395 people, healthy volunteers welcome
- Sponsor
- University of California, Davis
Premature Infants
Post-Discharge Growth and Development of Infants Who Received Targeted Fortification in the NICU
Extremely low birth weight (ELBW) infants are at risk for slow growth, metabolic abnormalities, and poor neurodevelopmental outcomes.
- Trial name
- NCT04190875
- Where
- United States
- Volunteers
- 120 people, healthy volunteers welcome
- Sponsor
- Baylor College of Medicine
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 - 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
Low; Birthweight, Breast Feeding, Exclusive
Indonesia After Discharge LBW Infant HMF Supplementation Study
Low birth weight (LBW) infant (1800-2449 gram) will be given the new human milk fortifier (HMF) which contains protein, lipid, carbohydrate and micronutrients after discharge.
- Conditions
- Low; Birthweight, Breast Feeding, Exclusive, Gestational Age and Weight Conditions
- Trial name
- DAHLIA (NCT04954807)
- Testing
- human milk fortified
- Where
- 4 sites in Indonesia
- Volunteers
- 163 people, healthy volunteers welcome
- Sponsor
- Universitas Indonesia
Breastfeeding, Exclusive, Breastfeeding
Donor Breast Milk and Breastfeeding Rates
The purpose of this pilot study is to determine if a randomized controlled study comparing a human milk diet versus a formula supplemented diet in late preterm and term infants in the neonatal intensive care unit (NICU) is…
- Trial name
- NCT04572581
- Testing
- Donor Breast Milk
- Where
- 2 sites in United States
- Volunteers
- 32 people
- Sponsor
- University of California, Los Angeles
Fatty Acid Desaturases, Polymorphism, Single Nucleotide
Genetic Variants Modulate Association Between Dietary n-3 LCPUFAs and DHA Proportion in Breast Milk
DHA is important for the development of brain and retina in newborns. Considering that exclusive breast feeding for at least 4 ~6 months are globally recommended, plus it is well known that nutrient requirement is determined by…
- Conditions
- Fatty Acid Desaturases, Polymorphism, Single Nucleotide, Milk, Human
- Trial name
- NCT03842891
- Where
- Taiwan
- Volunteers
- 193 people, healthy volunteers welcome
- Sponsor
- China Medical University Hospital