Clinical trials: C-difficile
Clostridioides Difficile Infection
LMN-201 for Prevention of C. Difficile Infection Recurrence
This is a multisite study to evaluate the safety, tolerability, and efficacy of LMN-201 in participants recently diagnosed with CDI who are scheduled to receive or are receiving SOC antibiotic therapy against C. difficile.
- Trial name
- NCT05330182
- Testing
- LMN-201
- Where
- 15 sites in United States
- Volunteers
- 375 people
- Sponsor
- Lumen Bioscience, Inc.
Clostridium Difficile
Fecal Transplant for Relapsing C. Difficile Infection
There has been an alarming increase in the incidence and severity of Clostridium difficile infection (CDI) in North America over the past decade.
- Trial name
- NCT01703494
- Testing
- Fecal Microbiota Transplantation
- Where
- 2 sites in United States
- Volunteers
- 53 people, healthy volunteers welcome
- Sponsor
- Colleen Kelly
Clostridium Difficile Infection, Infection
Microbiota Restoration Therapy for Recurrent Clostridium Difficile Infection (PUNCH CD3-OLS)
This is a prospective, multicenter, open-label Phase 3 study of a microbiota suspension of intestinal microbes. Patients who have had at least one recurrence of CDI after a primary episode and have completed at least one round of…
- Conditions
- Clostridium Difficile Infection, Infection, Communicable Diseases
- Trial name
- CD3-OLS (NCT03931941)
- Testing
- RBX2660
- Where
- 51 sites in United States, Canada
- Volunteers
- 793 people
- Sponsor
- Rebiotix Inc.
Clostridium Difficile Infection, Ulcerative Colitis
Fecal Microbial Transplantation for C. Difficile and/or Ulcerative Colitis or Indeterminate Colitis
Fecal Microbiota Transplantation will be offered to eligible C. difficile patients (does not require Investigational New Drug designation) and to eligible ulcerative colitis or indeterminate colitis patients as Investigational…
- Conditions
- Clostridium Difficile Infection, Ulcerative Colitis, Indeterminate Colitis
- Trial name
- FMT (NCT03268213)
- Testing
- Fecal Microbial Transplantation
- Where
- United States
- Volunteers
- 12 people
- Sponsor
- Stony Brook University
Clostridia Difficile Colitis, Clostridium; Sepsis
Comparing the Effectiveness of IV Bezlotoxumab Versus Placebo in Decreasing Morbidity and Mortality in Patients With Fulminant C. Diff Requiring Surgery.
A new medication, Bezlotoxumab, has been approved for treatment of recurrent Clostridium difficile diarrhea by the U.S. Food and Drug Administration. The way this new medication works, is by binding the toxin produced by C.
- Trial name
- NCT03756454
- Testing
- Bezlotoxumab, Normal Saline
- Where
- United States
- Volunteers
- 5 people
- Sponsor
- Ohio State University
Inflammatory Bowel Diseases, Clostridioides Difficile Infection
Xylitol Use for Decolonization of C. Difficile in Patients With IBD
This is a randomized, placebo-controlled, dose-ranging study to assess the safety and efficacy of xylitol as an oral therapeutic for decolonization of C. difficile in IBD patients.
- Trial name
- NCT05852587
- Testing
- Xylitol
- Where
- United States
- Volunteers
- 99 people
- Sponsor
- Brigham and Women's Hospital
Clostridium Difficile
Fecal Microbiota Transplantation (FMT) in Clostridium Difficile Infection (CDI) Not Responding to Antibiotics
Purpose: To study the changes in the microbiome and stool composition in patients with Clostridium Difficile Infection (CDI) who undergo Fecal Microbiota Transplantation (FMT), along with changes in their clinical characteristics.
- Trial name
- FMT (NCT03117582)
- Testing
- Stool specimen
- Where
- United States
- Volunteers
- 34 people
- Sponsor
- University of North Carolina, Chapel Hill
Clostridium Difficile
To Determine the Feasibility of a Fidaxomicin Study in Neonates and to Assess C. Difficile (Clostridium Difficile) Involvement in the Pathogenesis
The objective of this multi-center, prospective observational study is to determine the feasibility of a potential interventional study with fidaxomicin.
- Trial name
- DAISY (NCT01533844)
- Where
- 9 sites in France, Germany and 2 more
- Volunteers
- 1 people
- Sponsor
- Astellas Pharma Europe B.V.
Clostridium Difficile Infection, C.Difficile Diarrhea
The GRAFT Study: Gut RecolonizAtion by Fecal Transplantation
The primary objective of this study is to compare the gut microbiota and clinical outcomes of oral FMT during antibiotic treatment, immediately following antibiotic treatment, and placebo.
- Conditions
- Clostridium Difficile Infection, C.Difficile Diarrhea, CDI
- Trial name
- GRAFT (NCT03621657)
- Testing
- Low Dose FMT Capsule DE, Single Dose FMT Capsule DE
- Where
- United States
- Volunteers
- 1 people
- Sponsor
- University of Wisconsin, Madison
Clostridium Difficile Infection
Study to Assess Inhibition of Spore Production in Patients With C. Difficile Infections: Fidaxomicin Versus Vancomycin
The purpose of this study is to compare number of vegetative cells and spores in stool over time for fidaxomicin or vancomycin in patients diagnosed with their first episode of C. difficile infection.
- Trial name
- NCT01818141
- Testing
- Vancomycin, Fidaxomicin
- Where
- United States
- Volunteers
- 34 people
- Sponsor
- Hartford Hospital
Intestinal C. Difficile
Probiotic Intervention With Elderly Subjects
The study objective is to evaluate the effect of probiotic on faecal Clostridium difficile levels of elderly subjects.
- Trial name
- NCT01475942
- Testing
- Probiotic
- Where
- Finland
- Volunteers
- 104 people, healthy volunteers welcome
- Sponsor
- Danisco
Clostridium Difficile
Observational Study of C. Diff in Post-Transplant Patients
The primary objective of this observational study is to estimate the 90-day response rates to treatment for a first episode of C. difficile infections (CDI) in adult transplant recipients.
- Trial name
- CDIFF (NCT02747017)
- Where
- 9 sites in United States, Argentina and 3 more
- Volunteers
- 132 people
- Sponsor
- University of Minnesota
Clostridium Difficile Infection Recurrence
Bacillus Velezensis DSM 33864 for Reduction of the Risk of Recurrent Clostridioides Difficile Infections
The purpose of this study is to determine whether a single strain capsulated probiotic, when used after standard C. difficile antibiotic therapy, is effective in reducing the risk of infection recurrence mediated by a decrease in…
- Trial name
- NCT05606159
- Testing
- Bacillus velezensis DSM 33864
- Where
- United States
- Volunteers
- healthy volunteers welcome
- Sponsor
- Novozymes A/S
Clostridium Difficile
Probiotics for Clostridium Difficile Infection in Older Adults
The purpose of this study is to determine whether a probiotic, when used together with standard treatment, is effective in reducing duration of symptoms and preventing recurrence of infection in older adults with a first episode…
- Trial name
- PICO (NCT01680874)
- Testing
- Probiotic
- Where
- United States
- Volunteers
- 33 people
- Sponsor
- University of Wisconsin, Madison
Recurrent C. Difficile Infection
Rescue FMT with Bezlotoxumab for Recurrent C. Difficile Infection
The goal is to evaluate the benefit of adding bezlotoxumab to repeat fecal microbiota transplantation (FMT) in patients with recurrent Clostridioides difficile infections after failure of FMT alone.
- Trial name
- ZINFMT (NCT06669936)
- Testing
- Fecal microbiota transplantation ± bezlotoxumab
- Where
- United States
- Volunteers
- 24 people
- Sponsor
- Alexander Khoruts
Recurrent Clostridium Difficile Infection
Lyophilized Fecal Microbiota Transplantation for Recurrent Clostridioides Difficile Infection
The primary goal is to study participants with recurrent C. difficile infection (CDI) treated with lyophilized fecal microbiota transplantation (FMT). The safety, clinical response and relapse rate in patients will be assessed.
- Trial name
- NCT03834038
- Testing
- Lyophilized Fecal Microbiota Transplantation
- Where
- Canada
- Volunteers
- 158 people
- Sponsor
- Vancouver Island Health Authority
Clostridium Difficile Infection
Study of a Candidate Clostridium Difficile Toxoid Vaccine in Subjects at Risk for C. Difficile Infection
The aim of this study was to evaluate the efficacy of the Clostridium difficile vaccine to prevent primary symptomatic C. difficile infection (CDI) in participants at risk for CDI where there is a substantial unmet medical need.
- Trial name
- NCT01887912
- Testing
- C. difficile Toxoid Vaccine
- Where
- 335 sites in United States, Australia and 24 more
- Volunteers
- 9,302 people, healthy volunteers welcome
- Sponsor
- Sanofi Pasteur, a Sanofi Company
Clostridium Difficile Infection
Fecal Transplantation for Primary Clostridium Difficile Infection
In this randomized controlled trial the investigators want to compare the effect of one-time rectal instillation of fecal microbiota transplantation, compared to a ten-day antibiotic course for the treatment of primary…
- Trial name
- COLONIZE (NCT03796650)
- Testing
- Fecal microbiota transplantation, Vancomycin
- Where
- 18 sites in Norway
- Volunteers
- 104 people
- Sponsor
- Oslo University Hospital
Inflammatory Bowel Disease (IBD), Clostridioides Difficile Infection
Pilot Trial of Xylitol for C. Difficile De-Colonization in Patients With Inflammatory Bowel Disease
This 3+3 dose escalation pilot trial will assess the safety and efficacy of xylitol as an oral therapeutic for decolonization of C. difficile in the Inflammatory Bowel Disease (IBD) patient population.
- Trial name
- NCT06799039
- Testing
- Xylitol
- Where
- United States
- Volunteers
- 69 people
- Sponsor
- Brigham and Women's Hospital
Enterocolitis, Pseudomembranous, Diarrhea
A Study to Assess the Safety, Tolerability, Effectiveness and Absorption of Exodif™ Tablets in Clostridium Difficile-associated Diarrhea
Approximately 65 patients will be entered into this study taking place in North America. The aim of this study is to evaluate the safety, efficacy and absorption of an investigational drug in patients with C.
- Conditions
- Enterocolitis, Pseudomembranous, Diarrhea, Clostridium Difficile
- Trial name
- NCT00466635
- Testing
- GT267-004 (tolevamer potassium sodium)
- Where
- 13 sites in United States
- Volunteers
- 65 people
- Sponsor
- Genzyme, a Sanofi Company