Clinical trials: Human Milk Microbiome
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
Human Milk Microbiome, Bacterial Growth
Milk in Life Conditions (MiLC): Bacterial Composition of Human Milk Pumped and Stored in "Real-Life" Conditions
The MiLC trial is a randomized control trial of two different breast pump set-ups: mother's own and sterile. The objective of this trial is to investigate the bacterial composition of human milk pumped and stored in "real-life"…
- Trial name
- MiLC (NCT03123874)
- Testing
- Sterile pump set-up, Mother's Own pump set-up
- Where
- United States
- Volunteers
- 52 people, healthy volunteers welcome
- Sponsor
- Cornell University
Healthy Adults
Adult HMO Supplementation and the Gut Microbiome
The goal of this study is to assess the impact of Layer Origin's SuperHMO prebiotic formulation on the healthy adult gut microbiome.
- Trial name
- NCT06570330
- Testing
- SuperHMO, Non-GMO corn Maltodextrin, Rapid Absorption
- Where
- United States
- Volunteers
- 32 people, healthy volunteers welcome
- Sponsor
- Seeding Inc
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
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
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
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
Covid19, Human Milk
The Effect of Covid-19 on Breast Milk Microbiome and Its Bioactive Components
Coronavirus disease (Covid-19) is a new public health crisis threatening humanity caused by SARS-CoV-2. Although it originated in China's Hubei province in late 2019, it has spread to many countries around the world.
- Trial name
- NCT04836754
- Where
- Turkey (Türkiye)
- Volunteers
- 30 people, healthy volunteers welcome
- Sponsor
- Aysu Yıldız Karaahmet
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
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
Pregnancy
The Effect of Under-nutrition on the Human Microbiota
The purpose of this study is to determine whether a difference exists in the gut, oral, vaginal and human milk microbiome of under-nourished pregnant women as compared to healthy and obese pregnant women.
- Trial name
- NCT02021799
- Testing
- Moringa and Lactobacillus rhamnosus GR-1
- Where
- Tanzania
- Volunteers
- 77 people, healthy volunteers welcome
- Sponsor
- Western University, Canada
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
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
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
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
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
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