View clinical trials related to Clostridium Difficile Infection.
Filter by:A randomized, double-blind, placebo-controlled, pilot clinical study to assess the effect of Doctor's Biome Medical Food (DBMF) in individuals with Clostridium difficile infection (CDI)
Clostridioides difficile infection (CDI) is one of the most common hospital-acquired infectious diseases with a high mortality rate (6-30%). The treatment of CDI, especially the recurrent form of the disease is still considered a challenge. The FILTRATE randomized controlled trial aims to investigate the safety and efficacy of fecal filtrate transplantation in the treatment of recurrent CDI and compare it with conventional fecal microbiota transplantation (FMT).
Our objective of this study is to derive a real incidence of CDI in tertiary hospitals located through Korean peninsula. In order to get a close value to the truth, the study is planned to co-perform with a national study which was proposed in evaluation process to include more hospitals. Along with the incidence of CDI, clinical characteristics and outcome of CDI will be examined and microbiologic characteristics of C. difficile isolates from CDI patients are studied.
A higher frequency of recurrences in the University Hospital of Cabueñes (HUCAB) than in other hospitals in our area, including Central University Hospital of Asturias (HUCA) has been found. This increase does not seem to be related to underlying diseases, age, sex or predisposing factors classically described in this type of infection. This high rate of recurrence, together with the absence of response to all conventionally used antibiotic treatments, has important repercussions in the morbidity and mortality of patients, in the ecology of the hospital due to the risk of transmission of a strain of major severity and in the high costs associated with an increase in the hospitalization days of these patients, as well as in an eventual transfer of these to other structures specialized in fecal transplantation. Two hypotheses are proposed to explain the higher frequency reported: Hypothesis 1. There are alterations of the microbiome in patients with severe recurrences that favor the appearance of these. Hypothesis 2. The circulating strain in the hospital has intrinsic characteristics that make it more virulent, such as the presence of virulence or multiresistance factors. For this reason we design a descriptive, prospective multicentric study that will include all patients older than 18 years diagnosed with C difficile infection at the Central University Hospital of Asturias and the University Hospital of Cabueñes during the year 2020-2021
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 will be evaluated.
Interventional, single arm, single-centre trial to evaluate the effectiveness and safety of fecal microbiota therapy (FMT) in the investigators population.
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.
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.