Clinical trials: Human Milk Microbiome
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
Bacterial Communities
Sources of Bacterial Contamination in Human Milk Samples From the MiLC Trial
This observational study is a sub-study of the MiLC Trial (ClinicalTrials.gov Identifier: NCT03123874). Our objective is to characterize the bacterial communities of women's breasts, hands, their pump and milk collection kit, and…
- Trial name
- NCT03371511
- Where
- United States
- Volunteers
- 52 people, healthy volunteers welcome
- Sponsor
- Cornell University
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
Malnutrition Pregnancy, Malnutrition in Children
Early Life Malnutrition, Environmental Enteric Dysfunction and Microbiome Trajectories
Malnutrition in women of reproductive age remains a public health concern in Sub-Saharan Africa (SSA). Malnutrition during pregnancy affects foetal growth with a tendency of the exposed infants to also develop it.
- Conditions
- Malnutrition Pregnancy, Malnutrition in Children, Malnutrition (Calorie), Environmental Enteric Dysfunction
- Trial name
- UZBCS-2 (NCT07195006)
- Testing
- Malnutrition in pregnancy as exposure, Poor WASH living conditions as exposure
- Where
- Zimbabwe
- Volunteers
- 368 people, healthy volunteers welcome
- Sponsor
- University of Zimbabwe
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
Obesity
The Effects of Natural Sugars in Breast Milk on Healthy Infant Growth and Development
This study will investigate the effects of breastfeeding and breastmilk composition on infant gut microbiome development as well as obesity and cognitive outcomes.
- Trial name
- NCT04434027
- Where
- United States
- Volunteers
- 221 people, healthy volunteers welcome
- Sponsor
- University of Southern California
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
Preterm Birth, Neurodevelopmental Disorders
Guangzhou Preterm and Term Birth Cohort Study
The Guangzhou Preterm-Term Birth Cohort (GPTBC) is a prospective observational study of how early-life nutrition, environmental exposures, and family factors relate to the health and development of preterm and term infants and…
- Conditions
- Preterm Birth, Neurodevelopmental Disorders, Overweight, Obesity
- Trial name
- GPTBC (NCT07756177)
- Testing
- No Intervention: Observational Cohort
- Where
- China
- Volunteers
- 200 people, healthy volunteers welcome
- Sponsor
- Sun Yat-sen University
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
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, 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
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
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
Irritable Bowel Syndrome
An Intervention Study Using HMOs to Improve IBS Symptoms
There is now strong evidence implicating the human gut microbiota in many gastrointestinal diseases, including irritable bowel syndrome (IBS).
- Trial name
- GUT-HEAL-IBS (NCT06281600)
- Testing
- Human milk oligosaccharide
- Where
- United Kingdom
- Volunteers
- 44 people
- Sponsor
- Glenn Gibson
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
Study Focus: Weaning Gut Microbiota
Human Milk Oligosaccharides' Impact on Maturation of the Gut Microbiota
Human milk oligosaccharides (HMOs) are the third largest component of human milk after fat and milk sugar (lactose). HMOs play an important role in selecting the gut microbiota (GM) in newborn breastfed infants.
- Trial name
- Milkome (NCT07026526)
- Where
- Denmark
- Volunteers
- 18 people, healthy volunteers welcome
- Sponsor
- Technical University of Denmark
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
Microbiome, Stress
Investigating the Detection of Bovine and Soy Proteins in Human Milk
This study is a randomized, cross-over, dietary intervention research design comprising a 5-day run-in period, two 3-day dietary interventions, and a 2-day washout period.
- Conditions
- Microbiome, Stress, Food Allergy in Infants
- Trial name
- NCT04851340
- Testing
- Cow's Milk, Soy Milk
- Where
- United States
- Volunteers
- 38 people, healthy volunteers welcome
- Sponsor
- University of Idaho
Microbial Colonization, Preterm Birth
Matching Donor Human Milk On Maternal Secretor Status (MMOMSS) Study
This study will evaluate the impact of matching donor human milk to the maternal secretor status of very preterm infants (<34 weeks gestation) on the gut microbiome.
- Trial name
- MMOMSS (NCT04130165)
- Testing
- Matched donor human milk
- Where
- Canada
- Volunteers
- 13 people
- Sponsor
- University of Manitoba
Pediatric Obesity
Pediatric Obesity and the Infant Microbiome (BEACH)
The impact of breastfeeding on the infant microbiome in vaginally and Cesarean delivered offspring from obese and normal weight mothers.
- Trial name
- BEACH (NCT02843087)
- Where
- United States
- Volunteers
- 83 people, healthy volunteers welcome
- Sponsor
- University of Florida