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A Multi-center, Single-arm Trial Exploring the Safety and Clinical Effectiveness of RBX2660 Administered by Colonoscopy to Adults with Recurrent Clostridioides difficile Infection
Rochester, Minn.
The purpose of this study is to explore the safety of RBX2660 when delivered by colonoscopy in subjects with recurrent Clostridioides difficile infection (rCDI).
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A Phase 2B Prospective, Randomized, Double-blinded, Placebo-controlled Clinical Study Demonstrating the Efficacy and Safety of Rebiotix RBX2660 (Microbiota Suspension) for the Treatment of Recurrent Clostridium Difficile Infection (PUNCH CD 2)
Rochester, Minn.
This is the first prospective, multi-center, double-blinded, randomized controlled study of a microbiota suspension derived from intestinal microbes. Patients who have had at least two recurrences of C. difficile infection (CDI) after a primary episode and have completed at least two rounds of standard-of-care oral antibiotic therapy or have had at least two episodes of severe CDI resulting in hospitalization may be eligible for the study. Patients whose CDI returns in less than 8 weeks after the last assigned study treatment may be eligible to receive up to 2 treatments with RBX2660 in the open-label portion of the study.
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A Phase 3 Open-Label Clinical Study to Evaluate the Safety and Tolerability of Rebiotix RBX2660 (microbiota suspension) in Subjects with Recurrent Clostridium difficile Infection
Rochester, Minn.
To assess the safety and tolerability of RBX2660 in subjects with recurrent CDI who have had prior recurrent CDI that was resolved with antibiotic treatment.
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A Phase 3 Prospective, Randomized, Double-blinded, Placebo-controlled Clinical Study to Evaluate the Efficacy and Safety of RBX2660 (Microbiota Suspension) for the Prevention of Clostridium Difficile Infection
Rochester, Minn.
This is a prospective, multicenter, randomized, double-blinded, placebo-controlled Phase 3 study of a microbiota suspension of intestinal microbes. Patients who have had at least two recurrences after a primary episode and have completed at least two rounds of standard-of-care oral antibiotic therapy or have had at least two episodes of severe CDI resulting in hospitalization within the last year may be eligible for the study. Subjects who are deemed failures following the blinded treatment per the pre-specified treatment failure definition may elect to receive an unblinded RBX2660 enema.
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A Phase 3, Randomized, Double-blind, Active Controlled Study to Compare the Efficacy and Safety of Ridinilazole (200 mg, Bid) for 10 Days With Vancomycin (125 mg, Qid) for 10 Days in the Treatment of Clostridium Difficile Infection (CDI) (Ri-CoDIFy 2)
Rochester, Minn.
The purpose of this study is to compare ridinilazole with vancomycin as comparator to treat Clostridium difficile Infection (CDI) with the goal of achieving comparable cure rates to standard of care, but reducing rates of recurrent disease.
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A Randomized, Double-blind, Placebo-Controlled, Multi-Center Phase 1b Study to Evaluate the Safety, Efficacy and Microbiological Response of Orally Administered ABI-M201 in Subjects with Mildly-to-Moderately Active Ulcerative Colitis with Ongoing Mesalamine Treatment
Rochester, Minn.
To evaluate a new oral treatment, ABI-M201 (or placebo) in individuals with mild to moderate Ulcerative Colitis who have sustained an inadequate response to ongoing mesalamine treatment.
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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) (PRISM4)
Rochester, Minn.
The purpose of this trial is to evaluate the effectiveness, safety, and tolerability of a single oral administration of CP101 for the prevention of recurrent Clostridioides difficile Infection (CDI) in adult patients.
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A Randomized, Placebo-Controlled, Double-Blind, Phase 1 Study of ART24 in Subjects Recently Cured of a Clostridioides difficile Infection (CDI) (ART24)
Rochester, Minn.
The purpose of this study is to evaluate the safety and tolerability of ART24 after 7 or 28 days of daily administration in recently-cured C. diff infection subjects.
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An Open-label Efficacy and Safety Assessment of Rebiotix RBX2660 (Microbiota Suspension) for the Treatment of Recurrent Clostridium Difficile Infection
Rochester, Minn.
This study will evaluate additional efficacy and safety information about RBX2660 for the treatment of recurrent Clostridium difficile infection (CDI). Enrolled subjects will receive 2 planned RBX2660 enemas.
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Donor Screening Experience and Outcomes from Fecal Transplant in Patients with C. Difficile Infection
Scottsdale/Phoenix, Ariz.,
Rochester, Minn.
The purpose of this study is to evaluate clinical experience with donor screening for fecal transplant, and to evaluate the outcomes from fecal transplant and understand risk factors for fecal transplant failure and relapse after fecal transplant.
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Effect of Fecal Microbiota Transplantation for Recurrent Clostridium Difficile Infection on Vancomycin Resistant Enterococci Status of Patients
Rochester, Minn.
The purpose of this study is to evaluate if Vancomycin Resistant Enterococci (VRE) can be eradicated in patients with Clostridium Difficile infection (CDI) through treatment with Fecal Microbiota Transplantation (FMT) when FMT is being done to treat recurrent CDI rather than VRE.
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Efficacy of Oral Vancomycin Prophylaxis for Prevention of Recurrent Clostridium Difficile Infection
Rochester, Minn.
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 antibiotics for a non CDI condition. Participants will be randomized to receive either placebo or oral vancomycin in addition to their prescribed antibiotic therapy.
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Fecal Microbiome Transplant National Registry
Rochester, Minn.
The overarching goal of the FMT registry is to expand knowledge and optimize practice in the transplantation of fecal microbiota or other gut-related-microbiota products.
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Fecal Microbiota Transplantation for C. Difficile Infection in Solid Organ Transplant Recipients (FMT in SOT (RECOVER))
Rochester, Minn.
The purpose of this trial is to examine the effect of Fecal Microbiota Transplantation (FMT) compared with Vancomycin for cure of recurrent C. diff infection (CDI) in solid organ transplant (SOT) recipients in a randomized, controlled clinical trial.
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Mayo Clinic Fecal Microbiota Transplant (FMT) Repository
Rochester, Minn.
The aim of this protocol is to create a repository for frozen stool samples from donors of Mayo Clinic Rochester MN, FMT program. We will collect a stool aliquot from each 50 grams of donor sample that is processed for FMT at Mayo Clinic Rochester.
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Recurrent Clostridium Difficile vs Post Infectious IBS: A Prospective Study
Rochester, Minn.
The purpose of this study is to assess patients suspected of recurrent C. difficile disease (rCDI) and using a combination of clinical and laboratory markers to determine disease versus post infectious irritable bowel syndrome (IBS) with C. difficile colonization.
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Treatment of Recurrent Clostridium Difficile Infection with RBX7455: A Dose-ranging, Prospective, single center, Open label Phase I Trial
Rochester, Minn.
The purpose of this study is to demonstrate the efficacy and safety of RBX7455 (an oral microbiota based drug) for the treatment of recurrent clostridium difficile infection (CDI) in subjects who have had at least one recurrence after a primary episode (i.e., at least two episodes) and have completed at least two rounds of standard-of-care oral antibiotic therapy. Study subjects will have their diarrhea resolved, i.e., would be having less than 3 watery bowel movements at the time of study enrollment for 48 hours or more.
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