View clinical trials related to Clostridium Difficile Infection.
Filter by:Data on the seroprevalence of antibodies to Clostridioides difficile surface proteins and toxins are scarce. In 1983, Viscidi et al. showed that antibodies to C. difficile toxins A and B were detected in 60 to 70% of an adult population. Two-thirds of the adults tested had a serological trace, probably linked to a previous encounter with C. difficile. One of the hypotheses raised would be that exposure to this pathogen occurs very early and regularly throughout our lives. Indeed, in this study, antibodies to C. difficile toxins were detected from early childhood and persisted over time even after 60 years. The antibody response did not appear to vary with age or terrain. However, these results were only qualitative and did not allow for inter-individual variations due to the limitations of the techniques used at the time. Finally, in this work, it was important to underline that the neutralizing character of the cytotoxic effect of toxins on cell culture was not observed in all patients. Since this seminal work, several studies have shown that the host immune response plays a central role in the pathophysiology of C. difficile infections (CDI). In 2000, Kyne et al. showed that after colonization with a toxigenic C. difficile strain, patients with asymptomatic carriage had significantly higher serum levels of IgG directed against toxin A than patients who developed disease. Subsequently, they also showed in 2001 that a serum response directed against toxin A after a first episode of CDI was associated with less recurrence. Finally, Leav et al. showed in 2010 that a serum response directed against C. difficile toxin B was also associated with protection against recurrent forms. Several studies have also suggested that the host immune response, this time directed against colonization factors, could also play a major role in the evolution and prognosis of CDI. In a previous study, investigators showed a significant difference in the level of anti-SlpA antibodies (S-layer component) between CDI patients and control patients. At the same time, the epidemiology of CDI has changed since 2003 due to the emergence of a new epidemic and hypervirulent strain (PCR ribotype 027) producing a third toxin, the binary toxin. The humoral response to this toxin remains poorly described to date. On the basis of these numerous studies, new therapeutic immunization strategies (active or passive) aimed at neutralizing the action of C. difficile toxins and colonization factors have been or are being developed. However, it remains to identify the patients likely to benefit from these innovative strategies. This was the main objective of the SERODIFF study (currently being finalized), which identified certain patient profiles in which no seroconversion or isotype class switching of antibodies was observed following CDI. The absence of neutralizing antibody production would seem to correlate with recurrent forms. Thus, these patients would be those who could be eligible for a passive immunization strategy such as the administration of anti-toxin B monoclonal antibodies, bezlotoxumab, recently marketed in France. In this study, investigators aim to evaluate the seroprevalence stratified by age group, sex and by the main risk factors for CDI. Furthermore, the neutralizing and protective effect of the detected antibodies against C. difficile virulence factors will be studied.
The primary objective of the study is to determine whether dietary intervention to increase fiber and decrease fat reduces C. difficile infection recurrence in a cohort of oncology patients.
Aim: To investigate if host factors, such as composition and diversity of intestinal microbiota and/or genetic determinants, are associated with a higher risk of recurrence of Clostridioides difficile infection (CDI). To generate a predictive tool based on epidemiological, clinical, genetic and microbiologic variables aimed to identify patients at a higher risk of CDI recurrence in a context of optimized ICD management. Design: Multicenter prospective cohort study. Patients: Older than 18 years patients with CDI diagnosis, made by IDSA criteria, in the participant centers. Follow-up: A stewarship program aimed to improve CDI management, including early detection of CDI recurrence, will be implemented in the participant centers. Blood samples for genetic testing and stool samples for intestinal microbiome studies will be collected. Variables and data analysis: The primary outcome variable will be the emergence of CDI recurrence. Potential independent predictors of recurrence, including genetic and microbiological factors, will be assessed. A predictive tool based on independent predictors of recurrence will be built in a development subpopulation. The performance of the model will be assessed by ROC curves, and sensititvity, especificity, as well as negative and positive predictive values will be calculated, both in the development subpopulation and in a validation subset.
This is a randomized, double-blind, placebo-controlled trial to determine the optimal dose and safety of oral alanyl-glutamine between 4, 24, and 44 g doses administered for 10 days with standard therapy among first time incident cases of uncomplicated C. difficile infection (CDI) in hospitalized, or outpatient, persons aged 18 or older. Our hypothesis is that alanyl-glutamine supplementation will decrease recurrence and mortality from CDI and these outcomes will be associated with improvement of inflammatory markers and restoration of intestinal microbiota function.
The objective of the present study is to derive a high-risk R-ICD prediction rule and a prospective implementation of this prediction rule.
The first line therapy for an initial episode of CDI (Clostridium difficile infection) is 10-14 days of oral vancomycin which is now recommended over metronidazole in the 2018 guidelines from the Association of Medical Microbiologists and Infectious Diseases of Canada (AMMI). Although response rates for the treatment of a first episode of CDI now approach 90%, approximately 25% of patients who have a complete response will develop recurrence (rCDI) within 8 weeks. Doctors' ability to predict recurrence is evolving, but remains very limited. The investigators hypothesize that by extending initial vancomycin therapy with a 2-week tapering regimen this will reduce the risk of rCDI. Starting at the end of the initial 14 days of therapy, participants will be randomized to receive an additional 14-days of placebo or vancomycin taper (125 mg orally twice daily x 7 days followed by 125 mg orally once daily x 7 days). This taper was chosen as it represents two steps of a commonly used 4-week vancomycin taper. The investigators' proposal to evaluate the extension of initial treatment from 14 to 28 days with a tapering dose of vancomycin represents a practical clinical trial that capitalizes on oral vancomycin's safety profile, worldwide availability, and relatively low cost.
This study seeks to correlate microbiome sequencing data with information provided by patients and their medical records.
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.
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.
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.