Clinical trials: Human Milk Microbiome
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
Infantile Colic, Breast Feeding
The Role of Human Milk Oligosaccharides and Microbiomes on Infantile Colic and Atopic Dermatitis in Term Infants
Background: Human milk oligosaccharides (HMO) and microbiota are both key factors for infants to shape the gut flora and develop the immune system.
- Conditions
- Infantile Colic, Breast Feeding, Atopic Dermatitis, Infant Formula
- Trial name
- NCT05992493
- Where
- Taiwan
- Volunteers
- 300 people, healthy volunteers welcome
- Sponsor
- National Cheng-Kung University Hospital
Very Low Birth Weight Baby, Early Nutrition and the Preterm Infant
Optimizing Nutrition and Milk (Opti-NuM) Project
Early nutrition critically influences growth, neurodevelopment and morbidity among infants born of very low birth weight (VLBW), but current one-size-fits-all feeding regimes do not optimally support these vulnerable infants.
- Conditions
- Very Low Birth Weight Baby, Early Nutrition and the Preterm Infant, Nutritional Requirements, Human Milk Fortification
- Trial name
- Opti-NuM (NCT06870981)
- Testing
- Opti-NuM is an observational secondary use of data/samples study, the investigators will analyze information and specimens from the MaxiMoM platform RCTs. No interventions form part of this study.
- Where
- 6 sites in United States, Canada
- Volunteers
- 1,100 people
- Sponsor
- The Hospital for Sick Children
Infant, Very Low Birth Weight
Growth and Microbiome Development in Very Low Birth Weight Infants Fed Primarily Mother's Own Milk vs. Donor Human Milk
A study to compare growth, development of the intestinal bacterial environment, and other short term outcomes in groups of babies fed primarily their own mother's milk compared to those who receive primarily donor human milk.
- Trial name
- NCT02573779
- Testing
- Observational - no intervention
- Where
- 2 sites in United States
- Volunteers
- 125 people
- Sponsor
- Baylor College of Medicine
Breast Milk Collection, Human Milk/Breastfeeding
Human Milk and Its Effect on Infant's Metabolism and Infant Gut Microbiome
This protocol explains the MAINHEALTH cohort. The study examine the influence of maternal health parameters on human breast milk composition and integrates milk phenotype with infant metabolism and infant gut microbial content…
- Conditions
- Breast Milk Collection, Human Milk/Breastfeeding, Human Milk Microbiome, Infant Gut Microbiome
- Trial name
- MAINHEALTH (NCT05111990)
- Where
- Denmark
- Volunteers
- 168 people, healthy volunteers welcome
- Sponsor
- University of Aarhus
Healthy Newborn Infants
Resilience to Antibiotic-induced Obesogenic Microbiota: Discovering Mechanism of Microbiota Modulation
The aim is to study whether the microbiota of children who are exposed to antibiotics at birth could be modified by synbiotic supplement and thereby reduce the risk of obesity, chronic diseases and respiratory tract infections.
- Trial name
- ReCoverHealth (NCT06974994)
- Testing
- Synbiotic Supplement
- Where
- Finland
- Volunteers
- 125 people
- Sponsor
- Turku University Hospital
Microbial Colonization
Comparing Impacts of Donor Human Milk to Formula Supplementation on the Gut Microbiome of Full-term Infants
The goal of this pilot randomized controlled trial (RCT) is to examine donor human milk (DHM) as a clinical intervention targeted at achieving beneficial microbiome signatures in full-term infants who are exposed to intrapartum…
- Trial name
- PPDHM (NCT05815433)
- Testing
- Donor Human Milk - Nutritional Replacement
- Where
- Canada
- Volunteers
- 105 people, healthy volunteers welcome
- Sponsor
- University of Calgary
Autism Spectrum Disorder, Neurodevelopmental Disorders
Combined Human Milk Oligosaccharides (HMOs) and Probiotics Intervention for Children With Autism
This research project will investigate if a supplement containing a unique combination of prebiotics and probiotics can influence behaviour in children diagnosed with autism spectrum disorder.
- Conditions
- Autism Spectrum Disorder, Neurodevelopmental Disorders, Anxiety
- Trial name
- NCT05151601
- Testing
- Experimental
- Where
- Australia
- Volunteers
- 60 people
- Sponsor
- The University of Queensland
Prematurity; Extreme, Feeding Disorder Neonatal
Early Protein Supplementation in Extremely Preterm Infants Fed Human Milk
The central hypothesis of this clinical trial is that, in extremely preterm infants, protein-enriched human milk diets compared to usual human milk diets during the first 2 weeks after birth increase fat-free mass (FFM)-for-age Z…
- Conditions
- Prematurity; Extreme, Feeding Disorder Neonatal, Breast Milk Expression, Growth Failure
- Trial name
- NCT04325308
- Testing
- Protein-enriched human milk diet, Usual human milk diet
- Where
- United States
- Volunteers
- 150 people
- Sponsor
- University of Alabama at Birmingham
Infant Development, Stress
Multisensory Early Oral Administration of Human Milk in Preterm Infants
The aims of this pilot are to determine the feasibility and acceptability of the Multisensory early oral administration of human milk (M-MILK) intervention, recruitment, retention, and obtain data for sample size estimation.
- Trial name
- M-MILK (NCT06230848)
- Testing
- Multisensory Early Oral Administration of Human Milk (M-MILK)
- Where
- United States
- Volunteers
- 14 people
- Sponsor
- Loyola University
Healthy Mothers, Healthy Infants
Maternal High Fibre Fermented Diet Effect on Breastfed Infant Gut Microbiome
Breastfeeding is recommended for babies from birth to six months old because breast milk provides all the nutrients babies need for growth and development.
- Trial name
- MumBabyGut (NCT06977113)
- Testing
- High Fibre Fermented Food Diet, Control Habitual Diet
- Where
- United Kingdom
- Volunteers
- 56 people, healthy volunteers welcome
- Sponsor
- University of Glasgow
Very Low Birth Weight Baby, Premature Birth
Human-derived Human Milk Fortifiers (H2MF), Gut Microbiota and Oxidative Stress in Premature Infants
This is a randomized controlled trial of a human-derived human milk fortifier (H2MF) vs standard bovine-derived human milk fortifier (HMF) evaluating fecal microbiota and fecal and urinary biomarkers of oxidative stress in…
- Conditions
- Very Low Birth Weight Baby, Premature Birth, Microbial Colonization, Oxidative Stress
- Trial name
- NCT03214822
- Testing
- H2MF
- Where
- Canada
- Volunteers
- 30 people
- Sponsor
- University of Manitoba
Healthy Infants
HMOs on Infant Gut Microbiota Modulation and Development of the Immune System in Healthy Infants
The goal of this clinical trial is to learn how a mixture of human milk oligosaccharides impacts the development of the infant microbiota, the immune maturation and how the interaction between the microbiota and immune maturation…
- Trial name
- BELIEF (NCT06631937)
- Testing
- Human Milk Oligosaccharides
- Where
- 2 sites in Denmark
- Volunteers
- 334 people, healthy volunteers welcome
- Sponsor
- University of Aarhus
Breast Feeding, Human Microbiome
Human Milk and Infant Intestinal Microbiome Study
This study will explore the effects of skin-to-skin contact (SSC) between mothers and their babies on the infant intestinal microbiome, the maternal skin microbiome and the breast milk microbiome.
- Trial name
- NCT03181269
- Testing
- Intervention education
- Where
- United States
- Volunteers
- 6 people, healthy volunteers welcome
- Sponsor
- University of Virginia