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Clostridium Difficile Infection clinical trials

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NCT ID: NCT03804736 Active, not recruiting - Clinical trials for Clostridium Difficile Infection

Fecal Microbiota Transplant by Oral Capsules With Lactobacilli for Recurrent Clostridium Difficile Infection

Start date: November 1, 2016
Phase: N/A
Study type: Interventional

Investigators designed an open, two-arm study to compare fecal microbiota transplant by oral capsules (FMT-c ) versus FMT-c enriched with Lactobacillus for treatment of C. difficile recurrent infection

NCT ID: NCT03796650 Recruiting - Clinical trials for Clostridium Difficile Infection

Fecal Transplantation for Primary Clostridium Difficile Infection

COLONIZE
Start date: July 17, 2019
Phase: Phase 3
Study type: Interventional

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 Clostridium difficile infection (CDI). The investigators hypothetsize that the instillation of feces from a healthy donor will be non-inferior to vancomycin in inducing a durable cure.

NCT ID: NCT03795233 Terminated - Clinical trials for Clostridium Difficile Infection

Fecal Microbiota Transplant for Primary CDI

Start date: August 23, 2019
Phase: Phase 1/Phase 2
Study type: Interventional

Clostridium difficile infection (CDI) is one of the most urgent health threats in the U.S. associated with antibiotic use. After an initial episode, disease recurrence is high and relapses can occur in 20-30% of people treated with oral vancomycin. An antibiotic course can affect the gut microbiome for years, and patients with CDI have additional dysbiosis of their gut flora. Oral vancomycin perturbs the gut microbiome further. Restoration of the microbiome with Fecal Microbiota Transplant (FMT) has been proven a highly efficacious and cost-effective treatment for recurrent CDI. FMT has had very limited study for a primary episode of CDI to date because an endoscopic procedure was the recommended route of delivery. However, FMT is now available via frozen oral capsules and has been shown to be non-inferior to FMT via colonoscopy in randomized controlled trials. The investigators hypothesize that outcomes after a first episode of CDI can be improved if the microbiome is restored with oral FMT. It is further hypothesized that this will compensate for any additional microbiome perturbation caused by administration of oral vancomycin and decrease the likelihood of recurrence. Because the hypothesis is based on restoration of the microbiome, the investigators propose this proof-of-concept pilot study to examine whether FMT administered after oral vancomycin therapy for primary CDI restores microbiome diversity compared to patients who do not receive FMT. Because of the potential health benefits, this approach deserves further study. The results from this pilot study on the microbiome diversity as well as the surveys to be conducted about GI symptomatology (e.g., diarrhea, abdominal pain, bloating), CDI recurrence and healthcare utilization, would provide preliminary data to support a randomized controlled, multicenter clinical trial.

NCT ID: NCT03788434 Completed - Clinical trials for Clostridium Difficile Infection

Phase 2 Study of VE303 for Prevention of Recurrent Clostridioides Difficile Infection

CONSORTIUM
Start date: February 8, 2019
Phase: Phase 2
Study type: Interventional

This study evaluated the safety and efficacy of VE303 for participants with primary C. difficile infection (pCDI) at high risk for recurrence or subjects with recurrent C. difficile infections (rCDI).

NCT ID: NCT03712722 Recruiting - Clinical trials for Clostridium Difficile Infection

Fecal Microbiota Transplantation (FMT) for Clostridium Difficile

CEFTA
Start date: October 1, 2018
Phase:
Study type: Observational

Faecal microbiota transplantation (FMT) is used for recurrent Clostridium difficile infection (rCDI) as part of an quality improvement initiative and conducted within the framework of Center for Faecal Microbiota Transplantation at Aarhus University Hospital (CEFTA).

NCT ID: NCT03710694 Completed - Clinical trials for Clostridium Difficile Infection

Safety and Efficacy of DAV132 in Patients at High-Risk for Clostridium Difficile Infection (CDI)

SHIELD
Start date: October 31, 2018
Phase: N/A
Study type: Interventional

The purpose of this study is to determine the safe use and evaluate the efficacy/performance of DAV132 in hospitalized patients at high risk for Clostridium difficile infection (CDI) and who receive fluoroquinolones (FQs) for the treatment of acute infections or for prophylaxis of febrile neutropenia.

NCT ID: NCT03654872 Recruiting - Clinical trials for Clostridium Difficile Infection

Clostridium Difficile Virulence Mechanism Study (CDVM Study)

CDVM
Start date: June 30, 2018
Phase:
Study type: Observational [Patient Registry]

This study is an observational study to collect stool samples from patients with Clostridium difficile infection (CDI) to investigate the virulence mechanisms of C. difficile ribotypes in Hong Kong, mainly ribotype 002. No intervention is involved.

NCT ID: NCT03643887 Withdrawn - Clinical trials for Clostridium Difficile Infection

Phase II Trial of Fecal Microbiota Transplant (FMT) for VRE and CRE Patients

Start date: September 1, 2022
Phase: Phase 2
Study type: Interventional

Vancomycin-resistant Enterococcus (VRE) and carbapenem-resistant Enterobacteriaceae (CRE) are multi-drug resistant organisms (MDROs) associated with healthcare settings and are a high priority for containment in public health. Healthcare-associated infections (HAIs) like VRE and CRE lengthen the duration of a hospital stay, increase the cost of hospitalization, and increase mortality. Because colonization precedes infection, prevention or treatment of VRE/CRE colonization is essential. We propose a treatment approach to promote gut decolonization by VRE and CRE without using antibiotics. Participants enrolled in this study will be randomized a one-time dose of either study drug or placebo, will be followed for 6 months, and will submit stool samples for analysis of several outcomes for the trial.

NCT ID: NCT03621657 Completed - Clinical trials for Clostridium Difficile Infection

The GRAFT Study: Gut RecolonizAtion by Fecal Transplantation

GRAFT
Start date: March 21, 2019
Phase: Phase 2
Study type: Interventional

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. The second objective is to assess the safety and feasibility of daily oral Fecal Microbiome Transplant (FMT) as a treatment option.

NCT ID: NCT03592082 Withdrawn - Clinical trials for Clostridium Difficile Infection

Use of Bismuth Subsalicylate in Clostridium Difficile Colitis

Start date: March 1, 2018
Phase: Phase 4
Study type: Interventional

Clostridium difficle infection is the leading cause of hospital acquired infection and infectious diarrhea in hospitalized patients. Eradication treatment for this infection is the challenging tasks for clinicians due to treatment resistance developed from new hypervirulent strains. The recurrence rate of this infection is around 20% and there is high likelihood(60-70%) of another episode after index recurrence. Given constant challenge new treatment options are under study. Aim of the study is to evaluate if use of bismuth subsalicylate (BSS) can decrease the length of stay in patients admitted with Clostridium difficile infection. Secondarily investigators will also see if there is any impact of BSS in decrease the recurrence.