Below are current clinical trials.8 studies in C. difficile infection
(open studies only).
Filter this list of studies by location, status and more.
The primary goal of this study will be to assess whether stool collected and frozen from anonymous screened unrelated donors can be as effective as stool freshly collected from recipient's parents when used in Fecal Microbial Transplant for the eradication of recurrent Clostridium difficile infections in children. In the current protocols, which are more than 90% effective, each child who is receiving a fecal transplant has to provide their own donor stool, usually from a parent or close relative. This requires considerable screening costs for each case and is logistically complicated as the donor must be present and must stool just prior to the transplant. The investigators hope to show that a small number of healthy donors can provide stool samples which can be frozen and banked and then thawed for use in numerous patients. The primary goal is to show that Clostridium difficile will be eradicated as effectively (Greater than 90% success) when using the stool from the frozen donors.
The study will also evaluate the inflammatory response and intestinal microbiome in young children aged 1-3 years with Clostridium difficile infections to better predict which ones will respond to fecal transplantation and which ones have incidental infections. For this question the investigators will gather stool samples to check for lactoferrin, calprotectin, and alpha1antitrypsin, and 16s ribosomal RNA analysis in children before and after the fecal transplants. The goal is to see if there is an intestinal microbiome that predisposes some children to getting sick from Clostridium difficile versus just having it incidentally.
This study is to see if PCR test developed at Mayo Clinic to diagnosis C. Difficile infections is able to predict the risk of recurrent infection.
The purpose of this study is to evaluate if Vancomycin Resistant Enterococci (VRE) can be eradicated in patients with Clostridium Difficile infection (CDI) through treatment with Fecal Microbiota Transplantation (FMT) when FMT is being done to treat recurrent CDI rather than VRE.
Scottsdale/Phoenix, Ariz., Rochester, Minn.
The purpose of this study is to evaluate clinical experience with donor screening for fecal transplant, and to evaluate the outcomes from fecal transplant and understand risk factors for fecal transplant failure and relapse after fecal transplant.
The study will involve administering a single dose of investigational drug or placebo in ascending dose cohorts. This study is designed to evaluate the safety and tolerability of investigational drug as well as the efficacy of investigational drug versus placebo in adults with primary (first episode) Clostridium difficile infection (CDI).
This study will evaluate efficacy and safety information about RBX2660 for the treatment of recurrent Clostridium difficile infection (CDI). Enrolled subjects will receive one treatment with RBX2660 (microbiota suspension).
The purpose of this study is to demonstrate the efficacy and safety of RBX7455 (an oral microbiota based drug) for the treatment of recurrent clostridium difficile infection (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. Study subjects will have their diarrhea resolved, i.e., would be having less than 3 watery bowel movements at the time of study enrollment for 48 hours or more.
The purpose of this study is to estimate the success, recurrence, and complications over the 90 day follow up period for the treatment of C. difficile infection in adult solid organ or stem cell transplant patients.
June 18, 2016
- Clostridium difficile-induced diarrhea. Merck Manual Professional Version. http://www.merckmanuals.com/professional/infectious-diseases/anaerobic-bacteria/clostridium-difficile-–induced-diarrhea. Accessed Feb. 5, 2016.
- Longo DL, et al., eds. Clostridium difficile infection, including pseudomembranous colitis. In: Harrison's Principles of Internal Medicine. 19th ed. New York, N.Y.: McGraw-Hill Education; 2015. http://accessmedicine.com. Accessed Feb. 5, 2016.
- Cammarota G, et al. Fecal microbiota transplantation for the treatment of Clostridium difficile infection: A systematic review. Journal of Clinical Gastroenterology. 2014;48:693.
- Waltz P, et al. Novel therapies for severe Clostridium difficile colitis. Current Opinion in Critical Care. In press. Accessed Feb. 8, 2016.
- Malani PN, et al. Expanded evidence for frozen fecal microbiota transplantation for Clostridium difficile infection: A fresh take. JAMA. 2016;315:137.
- LaMont JT. Clostridium difficile in adults: Epidemiology, microbiology, and pathophysiology. http://www.uptodate.com/home. Accessed Feb. 8, 2016.
- Kelly CP, et al. Clostridium difficile in adults: Treatment. http://www.uptodate.com/home. Accessed Feb. 8, 2016.
- Frequently asked questions about Clostridium difficile for healthcare providers. Centers for Disease Control and Prevention. http://www.cdc.gov/HAI/organisms/cdiff/Cdiff_faqs_HCP.html. Accessed Feb. 8, 2016.
- LaMont JT. Clostridium difficile in adults: Clinical manifestations and diagnosis. http://www.uptodate.com/home. Accessed Feb. 8, 2016.
- Surawicz CM, et al. Guidelines for diagnosis, treatment, and prevention of Clostridium difficile infections. The American Journal of Gastroenterology. 2013;108:478.
- Davidson LE, et al. Clostridium difficile and probiotics. http://www.uptodate.com/home. Accessed Feb. 9, 2016.
- Khanna S (expert opinion). Mayo Clinic, Rochester, Minnesota. Feb. 16, 2016.