Phase 4 N=259 Clinical Trial of Efficacy and Safety of Ergoferon in the Treatment of Viral Intestinal Infections in Children
Viral Intestinal Infection
Primary: Average Diarrhea Duration. — 43.4; 54.7 hours — p=0.004
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Completed trials with posted results — search by concept, filter by the parameters that matter at the bedside.
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 1 N=27 CampETEC Hyperimmune Bovine Colostrum (HBC)
Healthy Volunteer
Primary: Incidence of Adverse Events — 1; 1; 0; 1 events
Phase 1 N=48 Phase I Norovirus Challenge Model
Gastroenteritis Norovirus
Primary: The Occurrence of Norovirus-associated Illness in Secretor Positive Participants Through Day 4 After Challenge. — 3; 2; 7; 0 Participants
Phase 1 N=16 Evaluation of Infectivity and Illness of Norwalk GI.1 Virus Lot 001-09NV in the Human Challenge Model
Norovirus Infection
Primary: Frequency of Norovirus Gastroenteritis (NVG) — 5; 4 Participants
Phase 2 N=165 Norovirus Challenge Study
Norovirus Infections
Primary: Number of Participants Who Experienced Norovirus Gastroenteritis (NVG) — 34; 37 Participants
Phase 4 N=101 Potential Mechanisms for Intussusception After Rotavirus Vaccine-Pilot Study
Intussusception · Rotavirus Infections
Primary: The Effects of RV1 and RV5 With or Without Other Routine Immunizations on Gastrointestinal Anatomy — 2; 1; 0; 1 Participants — p=0.2
Phase 4 N=1,384 Safety and Immunogenicity of Sequential Rotavirus Vaccine Schedules
Rotavirus Infection
Primary: Number of Participants Developing a Serum Anti-rotavirus Immunoglobulin (Ig) A Titer of 20 or Greater in the WC3 IgA Assay — 186; 182; 175; 191 participants
Phase 2 N=4,748 Efficacy and Immunogenicity of Norovirus GI.1/GII.4 Bivalent Virus-like Particle Vaccine in Adults
Healthy Volunteers
Primary: Number of Participants With Moderate or Severe Acute Gastroenteritis (AGE) Occurring for >7 Days After Dosing Due to GI.1 or GII.4 Norovirus Strains (Excluding…
N/A N=1,545 Implementation of a Molecular Diagnostic for Pediatric Acute Gastroenteritis: The FilmArray GI Panel IMPACT Study
Infectious Gastroenteritis
Primary: Analysis of Diarrheal Illness Etiologies Identified in Stool Culture Compared to the FilmArray™ Gastrointestinal (GI) Panel — 434; 19 Participants
Phase 1 N=8 Safety and Immunogenicity of Rotavirus Vaccine (RotaTeq(R)) in Infants With Short Bowel Syndrome
Short Bowel Syndrome
Primary: Safety and Tolerability of the Oral RotaTeq® Vaccine — 18; 3 Individual Adverse Events
N/A N=68 Intravenous Vitamin C in the Treatment of Viral Infection, Especially in the Treatment of Shingles
Virus Diseases · Herpes Zoster
Primary: Change of Pain Measured by VAS — 5.8; 2.2; 0.6; 1.2 pain intensity
Phase 2 N=132 Norovirus Bivalent-Vaccine Efficacy Study
Prevention From Norovirus Infection
Primary: Percentage of Participants With Viral AGE Clinical Illness and Fecal Virus Excretion Detected by RT-PCR OR 4-Fold Rise In Anti-GII.4 Norovirus P Particle Antibody Titer…
Phase 2 N=840 Safety and Immunogenicity of Norovirus GI.1/GII.4 Bivalent Virus-Like Particle (VLP) Vaccine in Children
Norovirus
Primary: Percentage of Participants With a Seroresponse (Pan-Ig ELISA) in Cohort 1 — 77.4; 63.5; 74.5; 85.7 percentage of participants
Phase 2 N=135 A Study to Determine the Safety and Immunogenicity of Bivalent GI.1 and GII.4 Vaccines in Healthy Volunteers
Norovirus Infections
Primary: Number of Participants With Solicited Symptoms of Reactogenicity (Gastrointestinal [GI] and Systemic) — 20; 20; 2; 9 Participants
N/A N=20 Comparison of Virologic and Immunologic Responses to Raltegravir and Dolutegravir in the Gastrointestinal Tract of HIV-Positive Adults
Human Immunodeficiency Virus
Primary: Rectal Tissue Concentrations of Ralegravir and Dolutegravir — 5308; 810 ng/g — p=1.0
Phase 1 N=44 Intestinal Permeability in Preterm Infants
Prematurity · Intestinal Permeability
Primary: Intestinal Permeability — 0.0731; 0.0720 ratio — p=0.932
Phase 4 N=44 Studies of COVID-19 Patients Treated With Oral Bismuth Subsalicylate (Pepto-Bismol)
Diarrhea · COVID-19
Primary: Measure of Daily Stool Frequency for Patients With COVID Treated With Bismuth — 3 bowel movements
Phase 4 N=40 Vitamin D and Prebiotics for Intestinal Health in Cystic Fibrosis
Cystic Fibrosis · Dysbiosis
Primary: Shannon Index — 5.02; 4.96; 5.28; 5.73 Shannon index
Phase 4 N=620 Zinc and/or Probiotic Supplementation of Rotavirus and Oral Polio Virus Vaccines
Immunity to Oral Rotavirus Vaccine · Immunity to Oral Polio Vaccine · Shedding of Oral Rotavirus Vaccine
Primary: Number/Percentage of Subjects With Immune Response to Rotavirus Vaccine — 54; 40; 42; 37 Participants
N/A N=25 Pilot Project of Virologic and Immunologic Correlates of GALT Immune Reconstitution Following Raltegravir Therapy
HIV Infections · AIDS
Primary: the Percentage of CD3+/CD4+ Cells Per Cubic Millimeter at the Effector Sites in the Duodenal Tissues Obtained From Volunteers to the Antiretroviral Therapy Regimen Over…
Phase 2 N=202 Safety and Immune Response of a Rotavirus Vaccine in HIV-infected and Uninfected Children Born to HIV-infected Mothers
HIV Infection · Rotavirus Infection
Primary: Percentage of Participants Developing New Grade >=3 Adverse Events — 1.6; 4.7; 13.5; 12.8 Percentage of participants — p=0.62
Phase 2 N=420 Safety and Immunogenicity of Norovirus GI.1/GII.4 Bivalent VLP Vaccine
Healthy Volunteers · Norovirus, Prevention
Primary: Percentage of Participants With a Seroresponse (Pan-Ig ELISA) — 43.3; 62.1; 46.4; 35.5 percentage of participants
Phase 2 N=454 Safety and Immunogenicity of Norovirus Bivalent Virus-Like Particle Vaccine in Healthy Adults
Norovirus Prevention
Primary: Percentage of Participants With Solicited Local Adverse Events (AEs) at Injection Site After the First Injection — 7.8; 64.1; 72.7; 7.8 percentage of participants
Phase 3 N=700 Exploration of the Biologic Basis for Underperformance of Oral Polio and Rotavirus Vaccines in Bangladesh
Rotavirus Diarrhea · Vaccine Virus Shedding · Tropical Enteropathy
Primary: Presence of Fecal Shedding of Polio Vaccine Virus Determined by Culture (Polio Trial) — 99; 109 Participants — p=0.4
Phase 1 N=102 Bivalent Norovirus Vaccine Study
Gastroenteritis
Primary: Number of Participants With Solicited Local Adverse Events (AEs) Post Dose 1 — 4; 5; 6; 5 participants
Phase 4 N=220 The Effects of Increased Inoculum on Oral Rotavirus Vaccine Take and Immunogenicity
Rotavirus Infection · Vaccine Response Impaired · Vaccine Virus Shedding
Primary: Number (or Percentage) of Infants in Each Study Arm Who Test Positive for Fecal Rotavirus Vaccine-strain Virus Shedding Post-vaccination — 63; 55 Participants
N/A N=190 Effect of Probiotic on the Innate and Adaptive Host Response to Rhinovirus (EPIARR)
Common Cold
Primary: Interleukin-8 (IL-8) — 133; 122 pg/ml
Early Phase 1 N=76 Autonomic Neuropathy, GI Motility, and Inflammation in HIV
HIV Disease
Primary: Change in Breath Test — 28; 14 ppm
Early Phase 1 N=8 CCRC: A Project of the Treatment of HIV Enteropathy With ImmunoLin® Supplements
HIV
Primary: Number of Bowel Movements Per Day — 5.8; 2 bowel movements/day — p=0.008