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Clostridium Infections clinical trials

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NCT ID: NCT05526807 Terminated - Clinical trials for Clostridioides Difficile Infection

Ursodeoxycholic Acid in C. Difficile Infection

Start date: May 8, 2019
Phase: N/A
Study type: Interventional

The primary objective of the study is to assess tolerability and adherence to treatment with ursodeoxycholic acid

NCT ID: NCT04802837 Terminated - Clinical trials for Clostridioides Difficile Infection

Safety, Tolerability and the Pharmacokinetics of Ridinilazole in Adolescent Subjects

Ri-CoDIFy 3
Start date: May 19, 2021
Phase: Phase 3
Study type: Interventional

Study to evaluate the safety of ridinilazole in adolescent subjects and how ridinilazole is metabolized.

NCT ID: NCT04003818 Terminated - Clinical trials for Clostridium Difficile Infection-associated Diarrhea and Colitis

Efficacy and Safety of Teicoplanin in CDAD

Start date: May 15, 2020
Phase: Phase 4
Study type: Interventional

Primary Objective: Explore the efficacy of teicoplanin (100-200 mg administered orally twice a day for 7 to 14 days) in patients with Clostridium difficile infection-associated diarrhea and colitis Secondary Objective: Evaluate the safety of teicoplanin in patients with Clostridium difficile infection-associated diarrhea and colitis

NCT ID: NCT04000555 Terminated - Clinical trials for Clostridium Difficile Infection

Oral Vancomycin for Secondary Prophylaxis of Clostridium Difficile Infection (CDI)

Start date: September 1, 2019
Phase: Phase 4
Study type: Interventional

The purpose of this study is to gain further knowledge regarding the effectiveness of vancomycin prophylaxis in preventing Clostridium difficile infections in order to guide physicians' practices.

NCT ID: NCT03973697 Terminated - Clinical trials for Recurrent Clostridium Difficile Infection

Penn Microbiome Therapy for Recurrent Clostridium Difficile Infection

Start date: January 13, 2020
Phase: Phase 2
Study type: Interventional

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 Clostridium difficile infection (C diff).

NCT ID: NCT03970200 Terminated - Clinical trials for Severe-Complicated/Fulminant Clostridium Difficile Infection

Penn Microbiome Therapy (PMT) for Severe-Clostridium Difficile Infection (CDI)

Start date: January 16, 2020
Phase: Phase 2
Study type: Interventional

This is a randomized, open label, comparative, Phase II study to determine whether fecal microbiota transplant using Penn Microbiome Therapy products helps standard therapy to treat severe Clostridium difficile infection (C diff).

NCT ID: NCT03937999 Terminated - Clinical trials for Clostridium Difficile

Bezlotoxumab as Secondary Prophylaxis for C. Difficile in High-risk Hospitalized Patients Exposed to Antibiotics.

Start date: August 30, 2019
Phase: Phase 4
Study type: Interventional

This study will examine whether the human monoclonal antibody, bezlotoxumab administered AFTER acute Clostridioides difficile (C.diff) has resolved, but during a period of subsequent antibiotic therapy, will eliminate the high risk of C. diff relapse.

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: NCT03760484 Terminated - Clinical trials for Clostridium Difficile

Fecal Microbiota Transplant (FMT) Plus Fidaxomicin for Severe or Fulminant Clostridium Difficile Infection

Start date: January 21, 2019
Phase: Phase 2
Study type: Interventional

Fecal microbiota transplantation (FMT) has been very effective for patients who suffer from mild C diff infection (CDI) which recurs but it is unclear how effective FMT alone is in treating severe and fulminant CDI. Current evidence suggests that FMT in combination with vancomycin is required, and that multiple treatments are necessary. The investigators think fidaxomicin may be a better option in the context and may potentially reduce the number of FMT required. However, fidaxomicin has never been used to treat severe or fulminant CDI. In this pilot study, the investigators plan to use a combination of FMT plus fidaxomicin to determine efficacy and safety in treating patients with severe or fulminant CDI. The investigators want to see if this approach may reduce the number of FMT treatment required, and/or the length of hospital stay.

NCT ID: NCT03647995 Terminated - Clinical trials for Diarrhea, Clostridium Difficile

Probiotics in the Prevention of Antibiotic Induced Diarrhea and Clostridium Difficile Associated Diarrhea.

Start date: September 1, 2018
Phase: N/A
Study type: Interventional

The objective of this study is to determine the efficacy of probiotics containing 25Bn (billion) CFU (colony-forming unit) of Lactobacillus rhamnosus, Sacchromyces boulardii and Bifidobacterium breve in the prevention of antibiotic induced diarrhea and Clostridium difficile diarrhea. The chosen population consists of 190 hospitalized patients taking antibiotics. Preselected and randomized patients will take probiotics once daily until 1 week after the course of antibiotic is over or a placebo with 0 CFU. The primary outcome is to detect the occurrence of an antibiotic-associated diarrhea. The secondary outcome is to assess the presence of Clostridium difficile toxins in stool culture.