Clinical trials: Clostridium Difficile Infections
Clostridial Infection, Dysbiosis
Safety and Efficacy of FMT in Individuals With One or More Recurrences of Clostridium Difficile Associated Disease (CDAD)
Multi-center, randomized, placebo controlled, partially blinded trial comparing the safety and efficacy of fecal microbiota transplantation versus placebo both delivered by rectal enema in subjects 18 years of age or older with…
- Conditions
- Clostridial Infection, Dysbiosis, Probiotic Therapy
- Trial name
- NCT03548051
- Testing
- Fecal Microbiota Transplantation (FMT), Saline
- Where
- 3 sites in United States
- Volunteers
- 10 people
- Sponsor
- National Institute of Allergy and Infectious Diseases (NIAID)
Recurrent Clostridium Difficile Infection, Clostridium Difficile Infection
Efficacy of Oral Vancomycin Prophylaxis for Prevention of Recurrent Clostridium Difficile Infection
This study evaluates the efficacy of prophylaxis with oral vancomycin for preventing recurrent Clostridium difficile Infection (CDI) in patients who have experienced at least one CDI episode in the last 180 days and are receiving…
- Conditions
- Recurrent Clostridium Difficile Infection, Clostridium Difficile Infection, CDI, C.Difficile Diarrhea
- Trial name
- NCT03462459
- Testing
- Vancomycin
- Where
- 2 sites in United States
- Volunteers
- 79 people
- Sponsor
- University of Wisconsin, Madison
Clostridioides Difficile Infection
Evaluation of CRS3123 vs. Oral Vancomycin in Adult Patients With Clostridioides Difficile Infection
The purpose of this research is to evaluate the primary objectives of safety and efficacy (rate of clinical cure) of 2 dosages of CRS3123 (200 mg and 400 mg) administered orally (po) twice daily (bid) and vancomycin administered…
- Trial name
- NCT04781387
- Testing
- CRS3123, Active Comparator
- Where
- 20 sites in United States, Canada
- Volunteers
- 43 people
- Sponsor
- Crestone, Inc
Clostridium Difficile Infection
Bezlotoxumab (MK-6072) Versus Placebo in Children With Clostridium Difficile Infection (CDI) (MK-6072-001)
The primary objectives of this study are to evaluate the pharmacokinetics (PK), safety, and tolerability of bezlotoxumab (MK-6072) in children aged 1 to <18 years of age with a confirmed diagnosis of Clostridium difficile…
- Trial name
- MODIFY III (NCT03182907)
- Testing
- Bezlotoxumab, Antibacterial drug treatment (ABD)
- Where
- 75 sites in United States, Argentina and 15 more
- Volunteers
- 148 people
- Sponsor
- Merck Sharp & Dohme LLC
Clostridium Difficile Infection
ACX-362E [Ibezapolstat] for Oral Treatment of Clostridioides Difficile Infection
Segments 2A and 2B of this trial evaluate the safety, efficacy, pharmacokinetics, fecal concentrations, and fecal microbiome effects of ACX-362E [ibezapolstat] in patients with C. difficile infection (CDI).
- Trial name
- NCT04247542
- Testing
- Ibezapolstat, Vancomycin
- Where
- 29 sites in United States
- Volunteers
- 53 people
- Sponsor
- Acurx Pharmaceuticals Inc.
Clostridium Difficile Infection
Comparison of Cadazolid Versus Vancomycin in Children With Clostridium Difficile-associated Diarrhea (CDAD)
Cadazolid has demonstrated activity against a bacteria named Clostridium difficile in animal studies. The results of a first study conducted in adult patients have suggested efficacy of the new antibiotic, cadazolid, in the…
- Trial name
- NCT03105479
- Testing
- Cadazolid, Vancomycin capsule, Vancomycin solution
- Where
- 20 sites in United States, Belgium and 7 more
- Volunteers
- 1 people
- Sponsor
- Actelion
Clostridium Difficile Infection
Effect of Acid Suppression Medication on Pediatric Microbiome
The colonic microbiome is essential in health and disease, and is highly dynamic during the first several years of life. Proton pump inhibitors (PPIs) and histamine-2 receptor antagonists (H2RAs) are widely used in children, but…
- Trial name
- NCT02016820
- Testing
- Omeprazole (suspension), Lifestyle Modification
- Where
- United States
- Volunteers
- 7 people
- Sponsor
- Columbia University
Leukemia, Lymphocytic, Acute, Leukemia, Myeloid, Acute
High- Fiber/ Low-fat Diet for Prevention of Recurrent Clostridioides Difficile Infection in Oncology
The primary objective of the study is to determine whether dietary intervention to increase fiber and decrease fat reduces C. difficile infection recurrence in a cohort of oncology patients.
- Conditions
- Leukemia, Lymphocytic, Acute, Leukemia, Myeloid, Acute, Lymphoma, Clostridium Difficile Infection
- Trial name
- NCT04940468
- Testing
- Diet Intervention
- Where
- 2 sites in United States
- Volunteers
- 8 people
- Sponsor
- University of Colorado, Denver
Clostridium Infections
Safety and Immunogenicity Study of GSK's Clostridium Difficile Vaccine 2904545A When Administered in Healthy Adults Aged 18-45 Years and 50-70 Years
The purpose of this study is to generate safety, reactogenicity (assessment of any expected or unexpected side effect of the vaccine) and immunogenicity (ability to induce an immune response) data for the development of a…
- Trial name
- NCT04026009
- Testing
- C. difficile investigational vaccine based on the F2 antigen (GSK2904545A), C. difficile investigational vaccine based on the F2 antigen (GSK2904545A) adjuvanted with AS01B
- Where
- Belgium
- Volunteers
- 140 people, healthy volunteers welcome
- Sponsor
- GlaxoSmithKline
Recurrent C. Difficile Infection
A Trial of CP101 for the Prevention of Recurrent CDI (PRISM4)
This is a Randomized, Double-Blind, Placebo-Controlled, Phase 3 Trial of the Efficacy, Safety, and Tolerability of a Single Oral Administration of CP101 for the Prevention of Recurrent Clostridioides difficile Infection (PRISM4).
- Trial name
- PRISM4 (NCT05153499)
- Testing
- CP101
- Where
- 68 sites in United States, Canada
- Volunteers
- 19 people
- Sponsor
- Finch Research and Development LLC.
Clostridium Difficile Infection
Clostridium Difficile Vaccine Efficacy Trial
The Clover trial is evaluating an investigational vaccine that may help to prevent Clostridium difficile infection. Participants in the study are adults 50 years of age and older, who are at risk of developing Clostridium…
- Trial name
- Clover (NCT03090191)
- Testing
- Clostridium difficile vaccine
- Where
- 426 sites in United States, Argentina and 21 more
- Volunteers
- 17,535 people, healthy volunteers welcome
- Sponsor
- Pfizer
C. Diff. Infections
Exploratory Study to Assess Delivery of LMN-201 Components Via Enteric Capsules in the Gut of Individuals With Ostomies
This is a Phase 1, single-site, open label, exploratory study to assess delivery of LMN-201 components via enteric capsules in the gut of individuals with ostomies.
- Trial name
- NCT04893239
- Testing
- LMN-201 Anti-toxin B VHH-1, LMN-201 Anti-toxin B VHH-2, LMN-201 Anti-toxin B VHH-3
- Where
- 3 sites in Australia
- Volunteers
- 12 people, healthy volunteers welcome
- Sponsor
- Lumen Bioscience, Inc.
Clostridium Difficile Infection
A Study of MK-6072 and MK-3415A in Participants Receiving Antibiotic Therapy for Clostridium Difficile Infection (MK-3415A-002)
MK-3415A is the combination of monoclonal antibodies to Clostridium (C.) difficile toxin A (MK-3415) and toxin B (MK-6072). This study will investigate whether: 1) treatment with MK-6072 or MK-3415A in addition to standard of…
- Trial name
- MODIFY II (NCT01513239)
- Testing
- MK-6072, MK-3415A, SOC
- Volunteers
- 1,203 people
- Sponsor
- Merck Sharp & Dohme LLC
Recurrent Clostridium Difficile Infection
Penn Microbiome Therapy for Recurrent Clostridium Difficile Infection
This is a randomized, open label, comparative, Phase II study to determine which dose of fecal microbiota transplant using Penn Microbiome Therapy (PMT) products is most effective in treating and preventing recurrence of…
- Trial name
- NCT03973697
- Testing
- Penn Microbiome Therapy - 001, Penn Microbiome Therapy - 002, Penn Microbiome Therapy - 003
- Where
- United States
- Volunteers
- 9 people
- Sponsor
- University of Pennsylvania
Clostridium Difficile Infection Recurrence
Efficacy, Safety, and Tolerability Study of Oral Full-Spectrum MicrobiotaTM (CP101) in Subjects With Recurrent C. Diff
Subjects with recurrent C. difficile infection will receive an oral dose of CP101 capsules one time in Treatment Group I or matching placebo one time in Treatment Group II.
- Trial name
- PRISM3 (NCT03110133)
- Testing
- Full Spectrum Microbiota
- Where
- 58 sites in United States, Canada
- Volunteers
- 206 people
- Sponsor
- Finch Research and Development LLC.
Clostridium Difficile Infections
Molecular Epidemiology of Clostridium Difficile Infections in Children
Objectives: 1. Describe the molecular epidemiology of Clostridium Difficile infection in children in the Chicago area. 2. Determine the clinical spectrum and risk factors for Clostridium Difficile infection secondary to…
- Trial name
- NCT01957761
- Where
- United States
- Volunteers
- 132 people
- Sponsor
- Ann & Robert H Lurie Children's Hospital of Chicago
Diarrhea, Clostridium Infections
Efficacy and Safety of BIO-K + CL1285 in Prevention of Antibiotic-associated Diarrhea in Hospitalized Adult Patients
The purpose of this study is to evaluate the efficacy and safety of Bio-K + CL1285 versus placebo in the prevention of antibiotic-associated diarrhea in hospitalized adult patients.
- Trial name
- NCT00328263
- Testing
- Lactobacillus acidophilus CL1285 and Lactobacillus casei
- Where
- 8 sites in Canada
- Volunteers
- 472 people
- Sponsor
- Bio-K Plus International Inc.
Inflammatory Bowel Diseases, Ulcerative Colitis
Prevention of Recurrent Clostridium Difficile Infection (CDI) in Patients With Inflammatory Bowel Disease (IBD).
The study will compare the effectiveness of Bezlotoxumab in individuals with active C. diff ( Clostridium difficile) infection who are diagnosed with Inflammatory Bowel Disease.
- Conditions
- Inflammatory Bowel Diseases, Ulcerative Colitis, Crohn Disease, C. Diff. Infections
- Trial name
- NCT04626947
- Testing
- Bezlotoxumab
- Where
- United States
- Volunteers
- 19 people
- Sponsor
- David Binion, MD
Clostridium Difficile Infection, Diarrhea
Study of CB-183,315 in Participants With Clostridium Difficile Infection
This is a randomized, double-blind, single-placebo, active-controlled, dose ranging parallel group design with 3 arms. Two dose regimens of CB-183,315 dosed twice daily will be compared with the active comparator oral vancomycin…
- Trial name
- NCT01085591
- Testing
- CB-183,315, Vancomycin
- Where
- 32 sites in United States, Canada
- Volunteers
- 210 people
- Sponsor
- Cubist Pharmaceuticals LLC, a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA)
Gastrointestinal Bleeding, Stress Ulcers
Stress Ulcer Prophylaxis in the Intensive Care Unit
Stress ulcer prophylaxis (SUP) is standard of care in the intensive care unit (ICU), however the quantity and quality of evidence is low and potential harm has been reported.
- Trial name
- SUP-ICU (NCT02467621)
- Testing
- Pantoprazole, Saline (0.9%)
- Where
- 33 sites in Denmark, Finland and 4 more
- Volunteers
- 3,350 people
- Sponsor
- Dr. Morten Hylander Møller