Clinical trials: Infant Gut Microbiome
Premature Birth of Newborn, Enterocolitis, Necrotizing
A Randomized Controlled Trial Investigating if Antibiotic Use in the First 48 Hours of Life Adversely Impacts the Preterm Infant Microbiome
The purpose of this study is to determine whether antibiotics given immediately after birth alter the development of the developing preterm infant's microbiome, which may further alter overall clinical outcomes.
- Trial name
- NCT02477423
- Testing
- Ampicillin, Gentamicins
- Where
- United States
- Volunteers
- 27 people, healthy volunteers welcome
- Sponsor
- University of Chicago
Colic, Inflammation
Effect of Lactobacillus Rhamnosus GG (LGG) on Infant Colic
This study will compare 2 currently marketed formulas in healthy full term babies: Nutramigen A+ (a hypoallergenic formula) and Nutramigen-Enflora (hypoallergenic formula with Lactobacillus GG (LGG)) during 3 months of formula…
- Trial name
- LGG (NCT01279265)
- Testing
- Nutramigen with Enflora, Nutramigen A+
- Where
- United States
- Volunteers
- 30 people, healthy volunteers welcome
- Sponsor
- The University of Texas Health Science Center, Houston
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
Enterocolitis, Necrotizing, Bacteremia
Antibiotic "Dysbiosis" in Preterm Infants
Prolonged antibiotic use in preterm neonates has significant consequences on the developing intestinal microbiome, metabolome and host response, predisposing the neonate to various major morbidities, including necrotizing…
- Conditions
- Enterocolitis, Necrotizing, Bacteremia, Bronchopulmonary Dysplasia, Intraventricular Hemorrhage
- Trial name
- NCT02784821
- Testing
- Antibiotic, Gastric fluid, Breast milk
- Where
- United States
- Volunteers
- 98 people
- Sponsor
- University of Florida
Cystic Fibrosis, Dysbiosis
Vitamin D and Prebiotics for Intestinal Health in Cystic Fibrosis
The study will assess if administration of high-dose vitamin D and a commonly used prebiotic (inulin) is effective to reduce gastrointestinal dysbiosis and to improve critical intestinal functions in Cystic Fibrosis with the…
- Trial name
- NCT04118010
- Testing
- Vitamin D3, Inulin
- Where
- United States
- Volunteers
- 40 people
- Sponsor
- Emory University
Infant Development, Gut Microbiome
INF108F in Infants With Food Protein Induced Proctocolitis
Single-center, randomized, double-blind, placebo-controlled trail evaluating INF108F in breastfed infants with FPIAP
- Conditions
- Infant Development, Gut Microbiome, Food Protein Induced Allergic Proctocolitis
- Trial name
- RESTORE (NCT05793112)
- Testing
- INF108F probiotic
- Where
- United States
- Volunteers
- 20 people, healthy volunteers welcome
- Sponsor
- Massachusetts General Hospital
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
Child Growth, Diversity of Microbiome
MORDOR II Burkina Faso: Longitudinal Trial
Globally, childhood mortality has shown a promising downward trend in recent years, however, many sub-Saharan countries still have relatively high child mortality rates.
- Conditions
- Child Growth, Diversity of Microbiome, Child Mortality, Resistance Bacterial
- Trial name
- GAMIN (NCT03676751)
- Testing
- Azithromycin
- Where
- Burkina Faso
- Volunteers
- 500 people, healthy volunteers welcome
- Sponsor
- University of California, San Francisco
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