View clinical trials related to Enterocolitis, Pseudomembranous.
Filter by:In this study the investigators will evaluate patients with IBD and and at least 2 confirmed c.difficile infections who will be undergoing FMT. The investigators will assess patients before FMT and then follow patients prospectively post FMT at week 1, 8 and 12 to assess for recurrence of c.difficile infection and IBD outcomes.
The purpose of this study is to demonstrate the efficacy and safety of RBX7455 for the treatment of recurrent CDI in subjects who have had at least one recurrence after a primary episode (i.e., at least two episodes) and have completed at least two rounds of standard-of-care oral antibiotic therapy.
The purpose of this study is to determine whether a bundle of measures specifically designed for patients with ICD and applied by and Infectious Diseases expert during a year period (2017) will improve the prognosis and reduce the rate of recurrence, compared with the baseline phase (2015) in which no intervention was made.
MET-2 clinical study is an Open label, single center, multiple dose pilot study of 19 patients. The study is designed to measure the resolution of diarrhea as well as the feasibility of administration and safety of MET-2 for the treatment of recurrent CDI in patients who have experienced at least two prior episodes of CDI and have developed recurrence after having completed standard-of care oral antibiotic therapy to treat CDI.
Administration of concomitant antibiotics (CA) is a known risk factor for treatment failure in the treatment of CDI, as well as for recurrence of CDI. Recent data suggested that among patients receiving CA, fidaxomicin is superior to vancomycin. While these data are encouraging, many clinicians remain unclear on how to apply these data to patient care. Additionally, patients were excluded from the trials presented to the FDA if it was expected that they would require ≥ 7 days of CA. Therefore, the clinical question still remains of how to apply these data to the real world patient who requires a long course of CA and develops CDI while on therapy. We therefore propose an open label, comparative and prospective study of fidaxomicin 200 mg twice daily vs oral vancomycin 125 mg four times daily for the treatment of CDI among patients who are receiving a long course of CA. We hypothesize that fidaxomicin will be superior to vancomycin with respect to clinical cure for patients with CDI.
The primary goal is to study patients with recurrent Clostridium difficile Infection (CDI) treated with lyophilized Fecal Microbiota Transplantation (FMT) in an open-labelled controlled trial. The treatment failure rate will be evaluated as defined by the persistence of diarrhea and a positive C. difficile toxin assay. The safety, clinical response, and relapse rate in patients will be assessed.
This study will evaluate efficacy and safety information about RBX2660 for the treatment of recurrent Clostridium difficile infection (CDI), and will compare the efficacy of one treatment with RBX2660 versus antibiotic-treated historical controls. Enrolled subjects will receive one treatment consisting of two doses of RBX2660 (microbiota suspension).
This study evaluates whether patients with Clostridium difficile infection (CDI) who are treated with fidaxomicin have less contamination of their skin and surrounding environment with spores of C. difficile than patients treated with other drugs (metronidazole or vancomycin)
LAY SUMMARY Clostridium Difficile (C.difficile) is a bacterial infection that can cause an inflammation of the colon, (C.difficile colitis). This sometimes progresses to a sudden and severe illness. The present treatment for fulminant colitis is a total abdominal colectomy with end ileostomy. This means, a surgery is performed which removes the entire diseased colon. The end of the small intestine is then brought out to the front of the abdomen as a stoma, and the patient wears a bag. Despite this invasive treatment, there remains a significant rate of death (38-50%). In addition, patients have a long recovery after this long operation and many (67%) will not be fit for a second big operation to remove the stoma (that is to reconnect the intestine). The purpose of our study is to determine if a loop ileostomy with colonic lavage will result in better outcomes. A loop ileostomy is when a loop of small intestine is brought out to the abdomen and the colon remains in the abdomen. The diseased colon, which is preserved, is washed with a warm solution (like the solution used in a colonoscopy preparation) and then treated with an antibiotic via this ileostomy. So far, one study has been done using a loop ileostomy with colonic lavage. 42 patients who underwent this treatment were compared to 42 patients that underwent the standard of care (complete removal of the colon with end ileostomy). The 42 patients who underwent a loop ileostomy showed a significant decrease in rate of death compared to the standard of care. Also, in the study, patients who underwent a loop ileostomy had a much higher rate of reconnection of the intestine (closing the stoma). The purpose of this study is to see if a loop ileostomy with colonic lavage can treat patients with fulminant colitis with less risk of death than the standard of care. Once the patient is diagnosed with fulminant colitis and meets the eligibility criteria, he/she will be asked by the surgeon on-call if they would like to participate in this research study. If they agree to be in this study, they must first sign a consent form. They may be asked by the surgeon to enroll in either the investigational arm (loop ileostomy) or the standard of care arm. After surgery, all patients will receive the same standard routine care. During the hospital stay, information will be taken from their chart for purposes of the study. Routine follow up visits with their surgeon will be at 2, 3, 6, and 12 months after surgery. If the patient decides to be in the study, the patient will be expected to complete all the follow up study visits. The patient will not be required to do anything extra or have any extra tests if they decide to be in the study at any of these visits.
This is a randomized controlled trial to compare the effect of a 10-day course of per oral metronidazole versus a one-time rectal instillation of an anaerobically cultivated human intestinal microbiota for the treatment of a first occurrence of Clostridium difficile infection (CDI). Recurrent CDI is common after standard antibiotic treatment. We hypothesize that the instillation of a healthy intestinal microbiota will be more effective in inducing a durable cure than metronidazole for primary CDI.