Clinical trials: Clostridioides Difficile Infection Recurrence
Clostridium Difficile Infection
Microbiota or Placebo After Antimicrobial Therapy for Recurrent C. Difficile at Home (MATCH)
The purpose of this study is to determine whether Fecal Microbiota Therapy (FMT) is effective vs. placebo in the prevention of C. difficile infection recurrence.
- Trial name
- MATCH (NCT03005379)
- Testing
- Fecal Microbiota Therapy (FMT)
- Where
- United States
- Volunteers
- 153 people
- Sponsor
- VA Office of Research and Development
Clostridium Difficile Infection
FMT Versus Antimicrobials for Initial Treatment of Recurrent CDI
The purpose of the study is to determine the safety and efficacy of Fecal Microbiota Transplant (FMT) for the treatment of the recurrence of Clostridium difficile infection (CDI) as compared to standard antibiotic therapy.
- Trial name
- NCT02255305
- Testing
- FMT, Antimicrobials
- Where
- United States
- Volunteers
- 6 people
- Sponsor
- Endeavor Health
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)
Clostridium Difficile
PROCLAIM -- Misoprostol in the Prevention of Recurrent CDI Prevent Recurrence of Clostridium Difficile Infection With Misoprostol
A total of 440 patients meeting enrollment criteria with a primary episode of C. Difficile Infection (CDI) will be enrolled across 3 sites.
- Trial name
- PROCLAIM (NCT03617172)
- Testing
- Misoprostol 100Mcg Tab
- Where
- 3 sites in United States
- Volunteers
- 6 people
- Sponsor
- Vanderbilt University Medical Center
Inflammatory Bowel Diseases, Clostridium Difficile Infection
ICON-2: FMT and Bezlotoxumab Compared to FMT and Placebo for Patients With IBD and CDI
This is a randomized controlled trial to assess the clinical and microbiological impacts of FMT in combination with Bezlotoxumab (bezlo) compared to FMT in combination with placebo in patients with both inflammatory bowel disease…
- Trial name
- ICON-2 (NCT03829475)
- Testing
- Bezlotoxumab, Fecal Microbiota Transplantation
- Where
- United States
- Volunteers
- 61 people
- Sponsor
- Brigham and Women's Hospital
Inflammatory Bowel Diseases, Clostridium Difficile Infection
The ICON Study: Outcomes After FMT for Patients With IBD and CDI
In this study the investigators will evaluate patients with IBD and and at least 2 confirmed c.difficile infections who will be undergoing FMT.
- Trial name
- NCT03106844
- Testing
- Fecal Microbiota Transplantation
- Where
- United States
- Volunteers
- 50 people
- Sponsor
- Brigham and Women's Hospital
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.
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
Recurrent Clostridioides Difficile Infection
The Clostridioides Difficile Trial of REC-3964
This is a multi-center, open-label study to investigate the safety, tolerability, pharmacokinetics (PK) and efficacy of REC-3964 (doses of either 250 mg or 500 mg PO every 12 hours) for the reduction of Clostridioides difficile…
- Trial name
- ALDER (NCT06536465)
- Testing
- REC-3964
- Where
- 2 sites in United States
- Volunteers
- 3 people
- Sponsor
- Recursion Pharmaceuticals Inc.
Clostridium Difficile Infection Recurrence
A Multi-center, Single-arm Trial Exploring the Safety and Clinical Effectiveness of RBX2660 Administered by Colonoscopy to Adults With Recurrent Clostridioides Difficile Infection
This trial will be initiated to explore whether RBX2660 (REBYOTA®) could be suitable for administration by the practice of colonoscopy.
- Trial name
- CDI-SCOPE (NCT05831189)
- Testing
- RBX2660
- Where
- 12 sites in United States
- Volunteers
- 41 people
- Sponsor
- Ferring Pharmaceuticals
Clostridium Difficile
A Prospective Trial of Frozen-and-Thawed Fecal Microbiota Transplantation for Recurrent Clostridium Difficile Infection
The primary goal of this proposal is to study the outcome of patients with recurrent Clostridium Difficile Infection (CDI) treated with frozen Fecal Microbiota Transplantation (FMT) in an open-labelled controlled trial.
- Trial name
- NCT02394275
- Testing
- Fecal Microbiota Transplant
- Where
- 2 sites in Canada
- Volunteers
- 140 people
- Sponsor
- McMaster University
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
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
Safety and Efficacy Study of VP20621 for Prevention of Recurrent Clostridium Difficile Infection
The objectives of this study are: (1) to evaluate the safety and tolerability of VP 20621 dosed orally for up to 14 days in adults previously treated for CDI; (2) to characterize the frequency and duration of stool colonization…
- Trial name
- NCT01259726
- Testing
- VP20621
- Where
- 59 sites in United States, Belgium and 4 more
- Volunteers
- 173 people
- Sponsor
- Shire
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
Recurrent Clostridium Difficile Infection, Primary Clostridium Difficile Infection
Primary or Recurrent Clostridioides Difficile Infection Treatment With Capsules of Lyophilised Faecal Microbiota vs Fidaxomicin
Patients with microbiota alterations developed after being exposed to antibiotics are especially susceptible to Clostridioides difficile infections (CDI).
- Trial name
- NCT05201079
- Testing
- MBK-01, Fidaxomicin
- Where
- 21 sites in Spain
- Volunteers
- 93 people
- Sponsor
- Mikrobiomik Healthcare Company S.L.
Clostridium Difficile Infection (CDI)
Microbiota Restoration Therapy for Recurrent Clostridium Difficile Infection (PUNCHCD3)
This is a prospective, multicenter, randomized, double-blinded, placebo-controlled Phase 3 study of a microbiota suspension of intestinal microbes.
- Trial name
- NCT03244644
- Testing
- RBX2660, Open label RBX2660 (only for confirmed CDI recurrence)
- Where
- 66 sites in United States, Canada
- Volunteers
- 320 people
- Sponsor
- Rebiotix Inc.
Recurrent C. Difficile Infection
Dose Ranging Study of the Safety and Efficacy of Orally Administered Lyophilized Fecal Microbiota Product (PRIM-DJ2727) for the Treatment of Recurrent Clostridium Difficile Infection (CDI)
To establish optimal dosing of lyophilized Fecal microbiota transplantation (FMT) product in the treatment of recurrent C. difficile infection
- Trial name
- NCT03298048
- Testing
- Low fecal microbiota dose, Mid fecal microbiota dose, High fecal microbiota dose
- Where
- United States
- Volunteers
- 17 people
- Sponsor
- The University of Texas Health Science Center, Houston
Recurrent Clostridium Difficile Infection
Microbiota Restoration Therapy for Recurrent Clostridium Difficile-associated Diarrhea
This study will assess the safety of a new biologic drug, RBX2660 (microbiota suspension) as a treatment for recurrent Clostridium difficile-associated diarrhea (CDAD), which is the primary symptom of recurrent Clostridium…
- Trial name
- PUNCH CD (NCT01925417)
- Testing
- RBX2660 (microbiota suspension)
- Where
- 13 sites in United States
- Volunteers
- 34 people
- Sponsor
- Rebiotix Inc.
Clostridium Difficile Infection Recurrence
Fecal Microbiota Transplantation for C. Difficile Infection in Solid Organ Transplant Recipients
The objective is to examine the effect of Fecal Microbiota Transplantation (FMT) compared with vancomycin for cure of recurrent C.
- Trial name
- NCT03617445
- Testing
- FMT oral capsule, Oral Vancomycin
- Where
- 5 sites in United States
- Volunteers
- 3 people
- Sponsor
- University of Wisconsin, Madison