N/A N=60 Proton Pump Inhibitors and Dysbiosis in Cirrhosis
Cirrhosis · Healthy
Primary: Number of Patients With Overgrowth of Oral Microbiota in Their Stool After PPI Therapy Withdrawal or Initiation — 45; 15 Participants
Clinical Trial Search
Completed trials with posted results — search by concept, filter by the parameters that matter at the bedside.
N/A N=92 Dietary Supplement With and Without a Probiotic and/or Antibiotic
Healthy Adults
Primary: Evaluation of the Changes in Microbiome Species Abundance and Diversity From Baseline Until End of Study (Day 35) — 27.00; 31.25; 27.00; 27.00 copies/ng DNA — p=<0.0001
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…
N/A N=62 Dietary Supplement With and Without a Probiotic
Healthy Adult Subjects
Primary: Evaluation of the Levels of B.Infantis in Stool by Quantitative PCR — 3.33; 3.33; 3.33; 3.33 copies/ng DNA — p=<0.0001
N/A N=225 Advanced Metagenomic Analysis of Human Colonic Microbiota in Patients With Chronic GI Disorders
Irritable Bowel Syndrome · Colitis, Ulcerative · Crohn Disease
Primary: Colonic-Mucosa Associated Microbial Species Per Compiled Participants in 5 Different Arms — 40; 30; 23; 23 microbial species population
Phase 4 N=14 Effects of Gastric Acid on Colonic Microbiome
Clostridium Difficile
Primary: Shannon Diversity Index Measuring Change in Microbiome Diversity — 0.18; 0.14 Shannon index — p=0.71
Phase 4 N=25 Effects of Lubiprostone on Small Bowel and Colonic Bacteria: A Correlation Study With Segmental and Whole Gut Transit
Constipation
Primary: Presence of Small Intestinal Bacterial Overgrowth — 8; 9 Participants — p=0.75
Phase 4 N=10 Effect of Antibiotics on Enteric Neurons and Glia
Antibiotic Enterocolitis
Primary: Change in Mean Number of Colonic Submucosal Neurons/mm^2 in the Colon After Antibiotic Treatment — 0 neuronal cells/mm^2
Phase 1 N=31 Biological Signatures, Probiotic Among Those With mTBI and PTSD
Mild Traumatic Brain Injury · Post Traumatic Stress Disorder
Primary: C-Reactive Protein Change — 0.113; -0.625 mg/L — p=.056
N/A N=107 Use of a Novel Synbiotic to Change Human Gut Bacteria and Improve Health in Obese Adults
Intestinal Microbiota and Barrier Function
Primary: Change in Microbiota, as Measured by Change in Microbiota Composition, Including Presence of B. Adolescentis BD1 and B. Animalis Supsp Lactis BB-12 — 7.9; 9.1; 8.8; 6.0…
Phase 2 N=12 Understanding the Role of Gut Microbiota in Hyperphagia in Prader-Willi Syndrome
Prader-Willi Syndrome · Obesity
Primary: Microbiome Analysis: Alpha Diversity — 4.89 Shannon index
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
Phase 2 N=60 Fecal Microbiota Transplantation for Pancreatitis
Acute Pancreatitis · Intestinal Bacteria Flora Disturbance · Intestinal Dysfunction
Primary: Number of Participants With Gastrointestinal Failure Score Equal 0 — 12; 14 Participants
N/A N=30 Obesity - Inflammation - Metabolic Disease: Effect of Lactobacillus Casei Shirota
Metabolic Syndrome
Primary: Change of Neutrophil Phagocytosis From Baseline to 3 Months — 0.06; 3.48 percentage of monocytes and granulocytes
Phase 1 N=23 Fecal Microbiota Transplantation in Pediatric Patients
Inflammatory Bowel Diseases (IBD) · Crohn's Disease (CD) · Ulcerative Colitis (UC)
Primary: Number of Occurrences of Adverse Events at 6 Months According to Adverse Event Term — 11; 5; 5; 3 Events
Phase 2 N=27 Investigation of the Gut Microbiota in Regulating Nutrient Absorption in Humans
Obesity
Primary: Stool Calories During OF and UF — 5.8; 8.9 percentage of calorie intake
Phase 4 N=22 Prebiotic Treatment in People With Schizophrenia - Pilot Study
Schizophrenia · Schizoaffective Disorder
Primary: Change in Serum Butyrate Levels — 2.42; 2.34; 2.88; 2.40 mg/ml
Phase 2 N=18 Beneficial Bacteria Treatment for Autism
Gastrointestinal Problems · Autism Spectrum Disorders
Primary: Gastrointestinal Symptom Responsiveness Scale (GSRS) — 2.74; 1.31 units on a scale — p=<0.001
N/A N=250 Calcium: Magnesium Balance, Microbiota, and Necroptosis and Inflammation
Colorectal Cancer
Primary: Comparisons of the Changes of Genera Prevotella by Mg Treatment vs. Placebo in Rectal Mucosa, Swab and Stool Samples — 0.108; 0.245; -0.076; 0.132 percentage of sample…
N/A N=50 Safety, Tolerability, and Biosignature of Humanized Prebiotics in Healthy Adults
Intestinal Health
Primary: Mean Composite PROMIS Maximum Scores — 4.3; 5.0; 3.0; 4.4 score on a scale
N/A N=4,561 Chronic Gastrointestinal Sequelae of an Acute Outbreak of Bacterial Gastroenteritis in Walkerton Ontario
Irritable Bowel Syndrome
Primary: Number of Participants With Post Infectious Irritable Bowel Syndrome — 23; 114 participants
Phase 2 N=24 Fecal Microbiota Transplant for Improvement of Metabolism
Obesity
Primary: Percent Change From Baseline in Insulin Resistance Based on Insulin-Stimulated Glucose Uptake (M) During Hyperinsulinemic Euglycemic Clamp — -3; 5 percent change — p=0.16
Phase 2 N=8 Fundamental Modification of the Gut Microbiota in the Treatment of Refractory Crohn's Disease
Crohn's Disease
Primary: Change in Disease Activity by Harvey Bradshaw Index — -5; -3 score on a scale
Phase 2 N=12 Blood Lipopolysaccharide (LPS) Rifaximin Study
Obese · Insulin Resistance · Metabolic Syndrome
Primary: Circulating LPS — 2.44; 1.86; 13.66; 10.00 EU/mL — p=>0.05
Phase 4 N=74 A Longitudinal Study to Identify IBS Phenotypes Using Fecal Microbiota and Hydrogen Breath Testing
Irritable Bowel Syndrome
Primary: Change in Mean Daily Abdominal Pain — 5.2; 5.3; 3.9; 3.8 score on a scale — p=0.78
Early Phase 1 N=13 Probiotics for Quality of Life in Autism Spectrum Disorders
Autism Spectrum Disorders · Anxiety
Primary: Change in Gastrointestinal (GI) Module of the Pediatric Quality of Life Inventory (PedsQL) at From Baseline at Week 8 — 17.97; 7.98 Units on a scale
N/A N=13 Effects of Dietary Fructose on Gut Microbiota and Fecal Metabolites in Obese Men and Postmenopausal Women: A Pilot Study
Non-Alcoholic Fatty Liver Disease · Obesity
Primary: Difference in the Distribution of Fecal Microbiota in Each Participant
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 Prebiotics on the Gut Microbiome Profile and Beta Cell Function
Type 1 Diabetes
Primary: Change in the Gut Microbiome Profile — 818.5; 229; 1610; 177 species count
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