Active clinical trials for "Clostridium Infections"

The host gastrointestinal microbiota is significantly influenced by antibiotic treatment which might favor Clostridium difficile infection (CDI), a frequent cause of community- and hospital-acquired, potentially life-threatening diarrhoea. CDI is followed by recurrence in 19-35% of patients despite adequate first line antimicrobial therapy. Currently there is no standardized therapy of recurrent or refractory CDI, but recent studies show remarkable effects of fecal microbiota transplantation (FMT). In the current project, we aim to ideally match host and donor for FMT success in recurrent or refractory CDI. We will establish a clinical standard operating protocol for FMT, we will evaluate its safety and efficacy, and the patient acceptance and quality of life before and after FMT. We will analyse persistence of the donor microbiota within the recipient, define predictive clinical recipient and donor factors for FMT success and correlate them with microbial host and donor metagenomics. We hypothesize that our work will yield novel, individualized strategies for recurrent or refractory CDI. In perspective, our results may be expanded to treatment of other inflammory bowel diseases.

This clinical study is designed to evaluate the safety and efficacy of oral administration of the food additive colostrum derived antibodies to Clostridium difficile for prevention of Clostridium difficile associated disease (CDAD).

Recurrent or refractory Clostridium difficile Infection (RCDI), with a recent increased incidence, is one of the most difficult and increasingly challenges for CDI. Since Fecal Microbiota Transplantation (FMT) has been accepted as the first-line therapy for RCDI, it is prudent to consider less invasive and more convenient means of administering FMT. The majority of reported FMT procedures have been performed with fresh or frozen stool suspensions via colonoscopy or nasojejunal tube. Nowadays, using acid-resistant hypromellose capsules, Youngster et al. significantly simplified the clinical practice of FMT and removed the need for invasive gastrointestinal procedures. However, to avoid undesirable disintegration, those capsules containing stool suspensions must be kept frozen all the time, which extremely limits their widespread application. The purpose of this study is to evaluate the efficacy and safety of freeze-dried, capsulized FMT for RCDI.

Recent data have demonstrated beneficial health outcomes of microbiota transplantation for the treatment of Clostridium Difficile infection. The investigators propose testing whether fecal transplantation from a healthy donor can lead to a recovery from Clostridium Difficile recurrent/treatment-resistant infection.

There has been an alarming increase in the incidence and severity of Clostridium difficile infection (CDI) in North America over the past decade. Relapsing infection is a common problem in patients treated for CDI, often requiring prolonged and expensive courses of oral vancomycin with limited alternative treatment options. This study will determine if fecal microbiota transplantation, which involves administering fecal flora from a healthy stool donor to a patient with relapsing CDI, is an effective and safe treatment.

This study was developed in response to the July, 2013 FDA draft guidance regarding FMT for CDI. The weight of the evidence in the literature suggests that FMT is the most effective treatment for ambulatory outpatients affected by recurrent CDI who fail conventional therapy. The anticipated benefits to research patients enrolled in this study include resolution of chronic diarrhea, return of bowel habits and nutritional status to normal, and resolution of chronic recurrent CDI. FMT involves the endoscopic instillation of freshly obtained stool with millions of live bacteria into the recipient's colon by endoscopic lavage. With any endoscopic procedure, there is a risk of perforated viscous. This is very rare, but the risk is increased with severe CDI. The risk of acquisition of communicable enteric or blood borne pathogen appears to be negligible.

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.

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.

This study is a two-arm, interventional, prospective, open-label, multi-center clinical trial with randomized and non-randomized study groups to evaluate the safety and effectiveness of faecal microbiota transplantation (FMT) for the treatment of adult patients suffering from primary or recurrent Clostridium difficile infection (CDI), using a novel, standardized microbiota transplantation system.

The purpose of the study is to investigate if treatment with fecal microbiota transplantation or rectal bacteriotherapy is superior to standard vancomycin in patients with recurrent Clostridium Difficile infections.