Clinical trials: Human Milk Microbiome
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
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
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
Breastfeeding
Effects of 5-Methyltetrahydrofolic Acid Supplementation on Maternal Health and One-Carbon Metabolism During Lactation
This double-blind, randomized, placebo-controlled parallel trial evaluates the effects of maternal 5-methyltetrahydrofolate (5-MTHF) supplementation during breastfeeding.
- Trial name
- OCMS (NCT07508917)
- Testing
- 5-MTHF Supplementation
- Where
- 2 sites in Spain
- Volunteers
- 36 people
- Sponsor
- Fundació Sant Joan de Déu
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
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
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
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