Clinical trials: Infant Gut Microbiome
Jaundice, Neonatal
Research of Diagnostic Value for BMJ Infants
Breast milk jaundice (BMJ) is the main cause of neonatal hyperbilirubinemia. Excessive serum unconjugated bilirubin level will not only cause the interruption or early termination of breastfeeding, but also cause kernicterus.
- Trial name
- NCT04527536
- Testing
- Neonatal hyperbilirubinemia
- Volunteers
- 300 people
- Sponsor
- Shanghai First Maternity and Infant Hospital
Gut Microbiome, Linear Growth
Effects of Complementary Feeding on Infant Growth and Gut Health
This study plans to learn more about how consuming different foods during the time of early complementary feeding (~5 to 12 months) affects growth and the development of bacteria living inside your baby's gut through school-age.
- Trial name
- MINT (NCT05012930)
- Testing
- Baby Foods - Meat, Baby Foods - Dairy, Baby Foods - Plant
- Where
- United States
- Volunteers
- 267 people, healthy volunteers welcome
- Sponsor
- University of Colorado, Denver
Healthy, Microbial Colonization
The Development and Health of the Intestinal Flora During the First Year of Life
In this research study (PREVENT 1), Alba Health, in collaboration with academic institutions (Uppsala University, COPSAC and University of Antwerp) is investigating the association between the developing gut microbiota…
- Trial name
- PREVENT (NCT06285630)
- Testing
- Observational, no intervation will be made
- Where
- Sweden
- Volunteers
- 300 people
- Sponsor
- Alba Health AB
Infantile Colic
Effect of Probiotics on Infantile Colic Symptoms
The aim of this clinical trial is to assess the impact of B. lactis B94 on participants with infantile colic. It is hypothesized that participants given the probiotic formula will have a significant reduction in their crying…
- Trial name
- EPIC (NCT06385054)
- Testing
- Probiotic
- Where
- 10 sites in France
- Volunteers
- 70 people
- Sponsor
- Lallemand Health Solutions
Infant Formula, Breast Milk
Effects of Breast Milk Simulated Infant Formula
Objective：The aim of this trial is to assess effects of Kieember and Yashili infant formula on body growth, behavior development, intestinal comfort, infectious diseases, allergic diseases, the absorption of nutrients and gut…
- Trial name
- NCT05295030
- Testing
- Breast milk, Kieember Infant formula, Ruibuen®, Yashili Infant formula, Ruibuen®
- Where
- China
- Volunteers
- 179 people, healthy volunteers welcome
- Sponsor
- Sun Yat-sen University
Very Preterm Infants
Feeding the Preterm Gut Microbiota - Impact of Infant-feeding on Preterm Gut Microbiota Development
Preterm infants are especially vulnerable to gut microbiota disruption and dysbiosis since their early gut microbiota is less abundant and diverse.
- Trial name
- FEEDMI (NCT03663556)
- Testing
- Infant-feeding
- Where
- 2 sites in Portugal
- Volunteers
- 60 people, healthy volunteers welcome
- Sponsor
- Universidade do Porto
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
Obesity, Metabolic Syndrome
Milk Types and Fish Oil in 9- to 12-Month-Old Infants
The objective of this intervention study is to examine the effect of whole cow's milk versus infant formula as primary milk sources with or without supplements of n-3 LCPUFA for growth, nutritional status, development, risk…
- Conditions
- Obesity, Metabolic Syndrome, Growth, Blood Pressure
- Trial name
- NCT00379171
- Testing
- Cow's milk with fish oil, Cow's milk without fish oil, Formula with fish oil
- Volunteers
- 100 people, healthy volunteers welcome
- Sponsor
- University of Copenhagen
Fecal Gut Microbiota
National Cohort Study on Infant Gut Microbiota and Nutrition
This study plans to collect 106,667 fecal samples from Chinese infants and children under 6 years old, with multi-dimensional stratification based on geographic location, mode of delivery, antibiotic exposure, and developmental…
- Trial name
- NCT07705685
- Testing
- Fecal sample collection and gut microbiome profiling
- Where
- China
- Volunteers
- 106,667 people
- Sponsor
- DiproBio (Shanghai) Co., Ltd.
Obesity, Childhood, Antibiotic Side Effect
Microbiome, Antibiotics, and Growth Infant Cohort
This cross-disciplinary study will assemble and longitudinally follow a large, diverse birth cohort to determine the relationships between early life antibiotic exposure, microbiome development, growth, antibodies, and…
- Trial name
- MAGIC (NCT03001167)
- Where
- United States
- Volunteers
- 509 people
- Sponsor
- Children's Hospital of Philadelphia
Healthy Infants
Colonisation Resistance Study
This study is initiated to investigate the effect of infant formulas with added specific prebiotic oligosaccharides on the reduction of specific potential pathogens and/or toxins.
- Trial name
- ColoR (NCT01507935)
- Testing
- Regular non-hydrolysed cow's milk
- Where
- 2 sites in Thailand
- Volunteers
- healthy volunteers welcome
- Sponsor
- Danone Asia Pacific Holdings Pte, Ltd.
Maternal Exposure, Health Behavior
Brain Probiotic and LC-PUFA Intervention for Optimum Early Life
Probiotics is suggested to play several roles in promoting health, including alleviating disease symptoms, protection against atopic disease, and modulating the immune system by improving the beneficial gut microbiota…
- Conditions
- Maternal Exposure, Health Behavior, Infant Development, Child Development
- Trial name
- BRAVE (NCT03851120)
- Testing
- Probiotics and LC-PUFA (480 mg DHA), Psychosocial stimulation and healthy eating education
- Where
- Indonesia
- Volunteers
- 314 people, healthy volunteers welcome
- Sponsor
- Universitas Indonesia
Mixed Flora; Infection
Preterm Infant Gut (PINGU) - a Norwegian Multi Centre Study
Necrotizing enterocolitis (NEC) is a leading cause of morbidity and mortality among infants in the neonatal intensive care unit (NICU).
- Trial name
- PINGU (NCT02197468)
- Where
- 7 sites in Norway
- Volunteers
- 60 people
- Sponsor
- University Hospital of North Norway
Microbiota, Gut Microbiome
Flourish: Exploring the Early Infant Gut Microbiome
The goal of this clinical trial is to learn whether microbiome analysis, education, and personalized recommendations can improve gut health and reduce early markers of immune-related conditions in infants aged 0-3 months…
- Conditions
- Microbiota, Gut Microbiome, Eczema, Microbiome
- Trial name
- NCT07333482
- Testing
- Tailored Recommendations, Consult Call, Educational Email Series
- Where
- United States
- Volunteers
- 250 people, healthy volunteers welcome
- Sponsor
- Seeding Inc
Cow's Milk Allergy
Oral Tolerance in Cow's Milk Allergy in the Infant
This study aims to determine if there is a link between cow's milk allergy in infants and regulatory T cells dysfunction that should be transient in infant acquiring oral tolerance after 12 month avoiding food and persistent in…
- Trial name
- NCT00298376
- Where
- France
- Volunteers
- 50 people, healthy volunteers welcome
- Sponsor
- Hospices Civils de Lyon
Prematurity, Intestinal Permeability
Intestinal Permeability in Preterm Infants
Necrotizing enterocolitis (NEC) is a life-threatening, gastrointestinal emergency characterized by increased intestinal permeability, affects approximately 7 to 10% of infants <1500 g birthweight, and typically occurs within 7 to…
- Trial name
- IPPI (NCT01756040)
- Testing
- Lactulose -rhamnose solution
- Where
- United States
- Volunteers
- 211 people
- Sponsor
- University of Maryland, Baltimore
Healthy Infants
Efficacy of Two HMOs in Chinese Infants
This is a randomized, controlled, double-blind, intervention trial of healthy male and female term infants to evaluate the efficacy of the 2 HMOs on beneficially modulating the gut microbiota, gut maturation, gut barrier…
- Trial name
- NCT06361719
- Testing
- Experimental Group (EG), Control Group (CG)
- Where
- China
- Volunteers
- 262 people, healthy volunteers welcome
- Sponsor
- Société des Produits Nestlé (SPN)
Gut Microbiota
Characterization of the Gastrointestinal Microbiota in Term Newborn Infants After 4 Weeks Supplementation of Probiotics
A mono center, open label, pilot study in term newborn infants. The study will investigate the effect of supplementation with probiotics on the presence of total Bifidobacterium in the infant feces.
- Trial name
- NCT04994834
- Testing
- Probiotics
- Where
- Denmark
- Volunteers
- 22 people, healthy volunteers welcome
- Sponsor
- Chr Hansen
Healthy Participants, Infants
First Complementary Foods and the Infant Gastrointestinal Microbiota
This study evaluates the effect of different complementary foods on the gastrointestinal microbiota of exclusively human milk fed infants.
- Conditions
- Healthy Participants, Infants, Gastrointestinal Microbiota
- Trial name
- NCT05492253
- Testing
- Infant fruit, Infant vegetable, Infant meat
- Where
- United States
- Volunteers
- 43 people, healthy volunteers welcome
- Sponsor
- University of Delaware
Infant Gut Microbiome
The EFFECT Study: Probiotic and HMO Supplementation in Infants
Lacto-N-tetraose (LNT) is a human milk oligosaccharide (HMO) present in human colostrum and milk. HMOs are largely undigestable and have no direct nutritive benefit to the infant, but act as a prebiotic substrate for beneficial…
- Trial name
- EFFECT (NCT03994315)
- Testing
- B. infantis EVC001, Lacto-N-tetraose (LNT)
- Where
- United States
- Volunteers
- 10 people, healthy volunteers welcome
- Sponsor
- Evolve BioSystems, Inc.