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Clostridium Difficile Infection clinical trials

View clinical trials related to Clostridium Difficile Infection.

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NCT ID: NCT04014413 Recruiting - Obesity Clinical Trials

Safety and Efficacy of Fecal Microbiota Transplantation

Start date: July 15, 2019
Phase: N/A
Study type: Interventional

The gut microbiota is critical to health and functions with a level of complexity comparable to that of an organ system. Dysbiosis, or alterations of this gut microbiota ecology, have been implicated in a number of disease states. Fecal microbiota transplantation (FMT), defined as infusion of feces from healthy donors to affected subjects, is a method to restore a balanced gut microbiota and has attracted great interest in recent years due to its efficacy and ease of use. FMT is now recommended as the most effective therapy for CDI not responding to standard therapies. Recent studies have suggested that dysbiosis is associated with a variety of disorders, and that FMT could be a useful treatment. Randomized controlled trial has been conducted in a number of disorders and shown positive results, including alcoholic hepatitis, Crohn's disease (CD), ulcerative colitis (UC), pouchitis, irritable bowel syndrome (IBS), hepatic encephalopathy and metabolic syndrome. Case series/reports and pilot studies has shown positive results in other disorders including Celiac disease, functional dyspepsia, constipation, metabolic syndrome such as diabetes mellitus, multidrug-resistant, hepatic encephalopathy, multiple sclerosis, pseudo-obstruction, carbapenem-resistant Enterobacteriaceae (CRE) or Vancomycin-resistant Enterococci (VRE) infection, radiation-induced toxicity, multiple organ dysfunction, dysbiotic bowel syndrome, MRSA enteritis, Pseudomembranous enteritis, idiopathic thrombocytopenic purpura (ITP), and atopy. Despite FMT appears to be relatively safe and efficacious in treating a wide range of disease, its safety and efficacy in a usual clinical setting is unknown. More data is required to confirm safety and efficacy of FMT. Therefore, the investigators aim to conduct a pilot study to investigate the efficacy and safety of FMT in a variety of dysbiosis-associated disorder.

NCT ID: NCT04012788 Recruiting - Clinical trials for Clostridium Difficile Infection

CDI Synbiotic Study

Start date: July 2019
Phase: N/A
Study type: Interventional

The investigators hypothesize that treatment with a synbiotic mixture consisting of inulin Lactobacillus rhamnosus (LGG®), Lactobacillus acidophilus (LA-5®), Lactobacillus paracasei (L. casei 431®) and Bifidobacterium lactis (BB-12®) can reduce the number of C. difficile recurrences significantly.

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: NCT03931941 Completed - Infection Clinical Trials

Microbiota Restoration Therapy for Recurrent Clostridium Difficile Infection (PUNCH CD3-OLS)

CD3-OLS
Start date: July 30, 2019
Phase: Phase 3
Study type: Interventional

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 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. Subjects may receive a second RBX2660 enema if they are deemed treatment failures following the initial enema per the protocol-specified treatment failure definition.

NCT ID: NCT03925636 Completed - Diet Modification Clinical Trials

Specific Carbohydrate Diet for Clostridium Difficile

SCD_cDiff
Start date: June 8, 2016
Phase: N/A
Study type: Interventional

The investigators are doing this research study to answer questions about a nutritional therapy called the Specific Carbohydrate Diet (SCD) for children with active Clostridium Difficile Infection. For this study, the investigators will be looking to determine: 1. Is SCD effective for the treatment for Clostridium Difficile Colonization? 2. Is the SCD well tolerated?

NCT ID: NCT03848689 Enrolling by invitation - Clinical trials for Clostridium Difficile Infection

FQ Restriction for the Prevention of CDI

FIRST
Start date: May 1, 2019
Phase:
Study type: Observational

This study evaluates the effectiveness of a new intervention, fluoroquinolone (FQ) Preprescription Authorization (PPA) strategy, to reduce and prevent Clostridium difficile infection (CDI) in hospital intensive care units (ICUs). The investigators will model a successful FQ PPA strategy in several Wisconsin ICUs and compare whether the intervention has improved outcomes in reducing CDIs. An additional goal of the study is to evaluate environmental and work system factors using systems engineering models in order to determine the most successful way to implement these new strategies.

NCT ID: NCT03834038 Active, not recruiting - Clinical trials for Clostridium Difficile Infection

Lyophilized Fecal Microbiota Transplantation for Recurrent Clostridium Difficile Infection

Start date: February 18, 2016
Phase: N/A
Study type: Interventional

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.

NCT ID: NCT03829475 Active, not recruiting - Clinical trials for Inflammatory Bowel Diseases

ICON-2: FMT and Bezlotoxumab Compared to FMT and Placebo for Patients With IBD and CDI

ICON-2
Start date: January 1, 2020
Phase: Phase 2
Study type: Interventional

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 (IBD) a and clostridium difficile infection (CDI). The investigators will prospectively enroll up to 150 IBD-CDI patients from 4 tertiary care FMT referral centers. Patients will be randomized 1:1 to either receive FMT in combination with Bezlo of FMT and a placebo infusion. Donor stool from healthy donors will be obtained from OpenBiome. OpenBiome is a nonprofit 501(c)(3) organization that provides hospitals with screened, filtered, and frozen material ready for clinical use. Patients will be enrolled and followed prospectively for 3 months post therapy. Stool and blood samples as well as clinical data will be collected at baseline, week 1, 8 and 12.

NCT ID: NCT03827447 Completed - Clinical trials for Clostridium Difficile Infection

Vancomycin for the Treatment of NAAT(+)/Toxin(-) C. Difficile

Start date: July 17, 2019
Phase: Phase 1
Study type: Interventional

This study proposes to: 1. Characterize the impact of oral vancomycin on C. difficile loads after end of treatment compared to a placebo group. 2. Determine the effect of oral vancomycin on structural and functional microbiome changes after end of treatment compared to a placebo group. 3. Characterize the impact of oral vancomycin against a placebo group on the daily frequency of loose stools by the end of treatment.

NCT ID: NCT03824795 Completed - Clinical trials for Clostridium Difficile Infection

Study to Assess Safety, Tolerability and Efficacy of Incremental Doses of MGB-BP-3 in Patients With CDAD

Start date: February 7, 2019
Phase: Phase 2
Study type: Interventional

The objective of this Phase IIa study is to assess the safety, tolerability, and efficacy of incremental doses of MGB-BP-3 in patients with Clostridium difficile-associated diarrhea (CDAD).