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Clostridium difficile (CDI) Clinical Trials

01:55 EST 19th November 2018 | BioPortfolio

The Effect of Fecal Microbiota Transplantation in Ankylosing Spondylitis (AS) Patients.

Ankylosing spondylitis (AS) patients often have subclinical gut wall inflammation. Gut dysbiosis has been associated with both AS and Crohn disease, both of which have several features in common. Gut dysbiosis is associated with specific microbial profile in AS patients. Fecal microbiota transplantation (FMT) has been proved to be safe and effective treatment for recurrent ...

Fecal Microbiota Transplantation (FMT) for Clostridium Difficile

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).

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

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.

Safety and Pharmacokinetics of a Single Dose of CCH (3.36 mg) in Subjects With EFP

This study will evaluate the safety and Pharmacokinetics (PK) of a single 3.36-mg dose of Collagenase Clostridium Histolyticum (CCH) in 4 quadrants concurrently, in subjects with Edematous fibrosclerotic panniculopathy (EFP). This study will provide insight to the PK profile and safety of concurrent subcutaneous injections of CCH 0.84 mg/quadrant into 4 quadrants.

Clostridium Difficile Virulence Mechanism Study (CDVM Study)

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.

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

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. Preselecte...

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

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...

Stool Biobanking and Impact of Antimicrobials on the Gut Microbiota in Patients With Bone and Joint Infection

Bone and joint infections (BJI) is a public health issue in industrialized countries. Implant-associated BJI, are complex hospital-acquired infections and eradication of the pathogen is challenging in such patients. A prolonged antimicrobial therapy is usually required from 6 weeks to 3 months, but some patients are eligible to several years of treatment and most of patie...

The GRAFT Study: Gut RecolonizAtion by Fecal Transplantation

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.

Fecal Microbiota Transplantation for Irritable Bowel Syndrome

Fecal microbiota transplantation (FMT) is a strategy that infuses a fecal suspension containing a healthy donor's microbiota into a patient's gut to restore his/her intestinal microbiome. FMT has a higher cure rate than standard antibiotic treatment for recurrent Clostridium difficile infections,and shows promising results in Inflammatory bowel disease(IBD).However, few...

Fecal Microbiota Transplantation for C. Diff 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. diff infection (CDI) in solid organ transplant (SOT) recipients in a randomized, controlled clinical trial.

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. The total study time period for study procedures followed by clinical monitoring is anticipated to be about 24 months (biomarker assays and other analyses may be completed after the 24 month time period). All participants will receive o...

Digestive Microbiota Transplant

The digestive microbiota graft is performed in three clinical circumstances: Clostridium difficile colitis is responsible for numerous deaths each year showing a severe prognosis. In 2013, fecal microbiote (or digestive microbiota) transplantation showed its superiority compared to the reference treatment in recurrences of C. difficile colitis. Our team has demonstrated th...

Use of Bismuth Subsalicylate in Clostridium Difficile Colitis

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 ...

To Compare Ridinilazole Versus Vancomycin Treatment for Clostridium Difficile Infection

Summit is developing ridinilazole as a novel antimicrobial for Clostridium difficile Infection (CDI) with the goal of achieving comparable cure rates to standard of care, but reducing rates of recurrent disease. A phase 2 proof of concept study, with vancomycin as comparator, demonstrated these attributes with a comparable safety profile. A high fecal concentration of ridi...

Comparison of Ridinilazole Versus Vancomycin Treatment for Clostridium Difficile Infection

Summit is developing ridinilazole as a novel antimicrobial for Clostridium difficile Infection (CDI) with the goal of achieving comparable cure rates to standard of care, but reducing rates of recurrent disease. A phase 2 proof of concept study, with vancomycin as comparator, demonstrated these attributes with a comparable safety profile. A high fecal concentration of ridi...

A Trial to Evaluate the Safety, Immunogenicity and Effect on Infant Immune Responses of a Single Dose of Tdap in Pregnant Women in Mali

This is a phase II, randomized, double-blind, active-controlled study to evaluate the safety, immunogenicity, and effect on infant immune responses of a single dose of Tdap in pregnant women in Mali. 200 healthy pregnant women, ages 18 through 39 years, inclusive, who meet all eligibility criteria will be will be randomly allocated in a 2:1 ratio to receive either Tdap (BOO...

Evaluation of MDW for Early Detection of Sepsis, Clinical Validity

The purpose of this study is to confirm the clinical validity and the performance of the Monocyte Width Distribution (MDW) parameter to detect the development of sepsis in a prospective study of ED adults who have blood draw including CBC-DIFF ordered upon presentation in a Spanish & French hospital and to verify cut-off for K3EDTA.

Relationship Between C. Difficile Toxins' Serum Level With C. Difficile Infection

To assess the association between Clostridium difficile (CD) toxins' serum levels and the grade of Clostridium difficile infection (CDI) severity/failure to CDI treatment and rate of recurrence. Furthermore, the kinetics of CD toxins in serum of CDI patients undergoing anti-CDI treatment, as well as the relationship between serum toxins levels and length of CDI diarrhea wil...

Evaluation Of Clostridium Difficile Vaccine Lot Consistency In Healthy Adults 65 To 85 Years Of Age

This study will investigate a Clostridium difficile vaccine in healthy adults 65 to 85 years of age, who will each receive 3 doses of vaccine. The study will assess the lot consistency, safety, and tolerability of the vaccine, and also look at the subjects' immune response to the vaccine.

Outcomes and Data Collection for Fecal Microbiota Transplantation for the Treatment of Recurrent Clostridium Difficile

The purpose of this study is to see if stool transplant performed by colonoscopy is effective at treating recurrent Clostridium difficile (C. diff) infection of the colon. During the procedure a stool sample is taken from a healthy donor (usually family member or close friend) and transplanted directly into the colon of the patient with C. diff infection. The goal of this e...

TReatment of Irritable Bowel Syndrome With Diarrhoea Using Titrated ONdansetron Trial

A placebo controlled study to determine the efficacy and mode of action of ondansetron in the treatment of irritable bowel syndrome with diarrhoea.

Microbial Restoration for 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 recurrent Clostridium difficile Associated Disease (CDAD). 162 male or female subjects will be enrolled in the study. Enrolled subjects will be rand...

Clinical/Microbiological Impact of a Specific Antimicrobial Stewardship Program for Nursing Homes

Background: In nursing homes, excessive and inappropriate use of antimicrobials, adverse events caused by these drugs, and infections by multidrug-resistant bacteria (MDRB) are more frequent than in the general population, posing a serious Public Health risk. Antimicrobial stewardship programs (ASP) are a key strategy to improve the use of antibiotics and to fight against b...

Pilot Study Using Oral Capsule FMT to Decolonize GI CRE

Carbapenem-Resistant Enterobacteriaceae (CRE) are bacteria that have become resistant to carbapenems by producing enzymes that break down carbapenems. The prevalence of CRE continues to rise globally but the treatment options are extremely limited. In case series, isolation of CRE from any site, whether there is clinical infection or not, has been associated with all-cause ...

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