N/A N=117 Growth and Microbiome Development in Very Low Birth Weight Infants Fed Primarily Mother's Own Milk vs. Donor Human Milk
Infant, Very Low Birth Weight
Primary: Intestinal Microbiome Diversity — 55.7; 46.3 taxa represented
Clinical Trial Search
Completed trials with posted results — search by concept, filter by the parameters that matter at the bedside.
N/A N=52 Milk in Life Conditions (MiLC): Bacterial Composition of Human Milk Pumped and Stored in "Real-Life" Conditions
Human Milk Microbiome · Bacterial Growth
Primary: Bacterial Community Richness — 64.2; 58.9; 64.0; 60.8 Observed taxa — p=0.9
N/A N=369 Defining the Intestinal Microbiota in Premature Neonates
Premature Intestinal Microbiota · Necrotizing Enterocolitis · Late Onset Bloodstream Infection
Primary: The Composition of Bacteria Present, Established by Ultra-deep RNA Gene Sequencing, in Pre-morbid Faecal Samples From Neonates With Necrotizing Enterocolitis and…
N/A N=40 Global Effects of a Probiotic Strain on Lactating Women
Mastitis
Primary: Evidence of Clinically Definite Mastitis Confirmed by Microbiological Cultures and Somatic Cell Counts — 3.09; 2.90 log10 CFU/mL
N/A N=99 Effect of Colostrum on Mucosal Immunity in Very Low Birth Weight (VLBWs) Premature Infants
Prematurity
Primary: Concentration of APPs Before Oral Priming — 17; 22; 35; 42 femtomole (fmol)
Phase 2 N=24 Fermented Milk Drink on Human Intestinal Microflora
Signs and Symptoms, Digestive
Primary: Modification of the Composition of the Intestinal Microflora: Bifidobacterium — 7.88; 7.60; 8.13; 8.10 log10 CFU/g — p=<0.05
N/A N=14 Multisensory Early Oral Administration of Human Milk in Preterm Infants
Infant Development · Stress
Primary: Feasibility of Intervention — 0; 7 Participants
Phase 2 N=134 Prophylactic Probiotics to Extremely Low Birth Weight Prematures
Feeding; Difficult, Newborn · Growth Failure · Necrotizing Enterocolitis
Primary: Time to Establish Full Enteral Feeds — 15; 15 days
Phase 3 N=483 Donor Milk vs. Formula in Extremely Low Birth Weight (ELBW) Infants
Infant, Newborn · Infant, Small for Gestational Age · Infant, Extremely Low Birth Weight
Primary: Bayley Scales of Infant Development (BSID) Cognitive Composite Score — 80.7; 81.1 Score on a scale
N/A N=180 Early Initiation of Milk Expression in Mothers of Very Low Birth Weight Infants
Breast Milk Expression
Primary: Pumped Milk Volume Day 1 — 3; 4; 5 mL — p=0.015
N/A N=27 A Randomized Controlled Trial Investigating if Antibiotic Use in the First 48 Hours of Life Adversely Impacts the Preterm Infant Microbiome
Premature Birth of Newborn · Enterocolitis, Necrotizing
Primary: Richness of the Preterm Infant Microbiome — 12.8; 11 16S rRNA gene amplicon sequence variants
N/A N=124 Newborn Feeding and Infant Phenotype
Breast Feeding
Primary: Change in Total Adipose Tissue Volume — 0.718; 0.901; 0.775 Litres
N/A N=24 Probiotics in Infants With Gastroschisis
Gastroschisis
Primary: Composition of the Fecal Microbiota — 42; 12; 1.1; 14 percentage of total bacteria — p=<0.01
N/A N=75 Effect of Natural Food on Gut Microbiome and Phospholipid Spectrum of Immune Cells in COVID-19 Patients
COVID-19
Primary: Gut Microbiome — 51.87; 46.1; 29.43; 29.77 Mean percentages of gut microbiota units — p=<0.05
N/A N=288 Prebiotic GOS and Lactoferrin With Iron Supplements
Iron-deficiency
Primary: Ratio of Harmful to Beneficial Bacterial Genera in Fecal Microbiota as Determined by Quantitative Polymerase Chain Reaction (qPCR) at 1 Month — 2.208; 1.530; 2.075…
N/A N=90 Effects of Probiotic and Prebiotic Combinations on Premature Infants
Premature Infants · Stool Bacterial Composition · Growth
Primary: Weight Gain — 618; 590; 682 Grams — p=>0.5
Phase 2 N=48 Oropharyngeal Administration of Colostrum to Extremely Low Gestational Age Newborns
Extremely Low Gestational Age Newborn · Premature Infant
Primary: Urinary Secretary IgA Concentration at 2 Weeks of Age — 233.8; 48.3 ng per g creatinine — p=0.006
N/A N=11 Effect of Milk Oligosaccharides and Bifidobacteria on the Intestinal Microflora of Children With Autism
Autism
Primary: Stool Microbiota Composition Change During Prebiotic Only Treatment — 2; 3; 1; 0 Participants
Phase 1 N=12 Effect of Medium Chain Triglyceride Intake on Colonization of Preterm Infants With Candida
Candida Infection · Premature Infant
Primary: Stool Fungal Burden — 500; 55000; 1671; 622.5 cfu per gram — p=0.9
N/A N=30 Effect of Lactobacillus Rhamnosus GG (LGG) on Infant Colic
Colic · Inflammation
Primary: Daily Average Crying and Fussing Duration According to Barr Diary Records — 111; 133 minutes
Phase 1 N=21 Gastrointestinal Microbiota in Primary Sclerosing Cholangitis and Biliary Atresia With Vancomycin
Primary Sclerosing Cholangitis · Biliary Atresia
Primary: Determine the Benefit of Oral Vancomycin Therapy for Primary Sclerosing Cholangitis and Biliary Atresia — 10; 0; 0; 0 participants
Phase 2 N=98 Antibiotic "Dysbiosis" in Preterm Infants
Enterocolitis, Necrotizing · Bacteremia · Bronchopulmonary Dysplasia
Primary: Number of Events of Composite Morbidities and Mortality, Including Necrotizing Enterocolitis (NEC), Late Onset Sepsis (LOS), Bronchopulmonary Dysplasia (BPD) and Death…
Phase 4 N=28 Cultures Before and After Decolonization in Community Dwelling Adults With Current S. Aureus Colonization
Human Microbiome
Primary: Change in the Abundance of Staphylococcus Aureus in the Nose After Decolonization — -781 fg/uL
N/A N=10 Effect of Surfactants on the Skin Microbiome
Healthy Skin
Primary: Relative 16S Abundance - Control Soap — 100; 74; 84; 100 Percentage of Baseline
N/A N=130 Maternal Role in Oral Feed Establishment in Preterm Neonates
Preterm Birth · Tube Feeding · Swallowing Disorder
Primary: Transition Time to Full Oral Feeding — 10; 9 days
Phase 2 N=15 Metformin to Augment Low Milk Supply (MALMS) Study
Low Milk Supply · Pre-diabetes · Insulin Resistance
Primary: Peak Change in Milk Output — 8; -58 milliliters
N/A N=103 PREterM FOrmula Or Donor Breast Milk for Premature Babies
Adiposity · Insulin Resistance · Metabolomic Profile
Primary: Total Body Adiposity — 0.893; 0.863; 0.809 Litres
N/A N=21 Donor Human Milk in Neonatal Abstinence Syndrome
Neonatal Abstinence Syndrome
Primary: Percentage of Infants Achieving a GI Subscore >2 Over the Study Period — 39; 61 Percentage of participants — p=0.001
Phase 1 N=15 Evaluation of the Efficacy of an Autologous Microbiome Transplant in Adult Atopic Dermatitis Patients
Atopic Dermatitis Eczema
Primary: Relative Abundance of Staphylococcus Aureus Compared to Baseline — 0.106; 12.9 Relative abundance of S. aureus
N/A N=32 Effects of Pre-, Pro- & Anti-biotics on Gut Microbiota
Human Gut Microbiota
Primary: Bacteria Prevalence in Stool — 22.3; 20.9; 18.0; 25.5 percentage of bacterial genera in stool — p=<0.05