Orange, California 92868


Purpose:

The purpose of this research is to investigate the efficacy of transplanting screened donor fecal material in treating patients with recurrent Clostridium difficile infection. Participants with refractory Clostridium difficile infection will be given healthy donor stool administered by colonoscopy or enema and their response will be evaluated by symptom questionnaire and stool testing for Clostridium difficile at 4 weeks after the treatment.


Criteria:

Inclusion Criteria for Recipient: - Between the age of 18 and 100 - Have positive Clostridium difficile polymerase chain reaction (PCR) or toxin - Have symptoms of > 3 watery loose stools a day for at least 2 consecutive days - Have failed at least one prior standard course of antibiotic therapy. Examples of standard therapy are: - Metronidazole 500 mg three times a day for 10 to 14 days - Vancomycin 125 mg four times a day for 10 to 14 days - Not be pregnant and have negative urine and/or serum human chorionic gonadotropin (hCG) test - Not be taking oral or intravenous steroids in the past three months. - Not on biologic agents, anti-tumor necrosis factor (anti-TNF) agents, cyclosporine, mercaptopurine, azathioprine, methotrexate or chemotherapy in the preceding 3 months - Not have profound immunosuppression: Chemotherapy the preceding 3 months, HIV/AIDS, decompensated cirrhosis - Not be in the Intensive Care Unit - Not be a transplant recipient Exclusion Criteria for Recipient: - Not between the age of 18 and 100 - Does not have positive Clostridium difficile PCR or toxin - Does not have symptoms of > 3 watery loose stools a day for at least 2 consecutive days - Has not failed at least one prior standard course of antibiotic therapy. Examples of standard therapy are: - Metronidazole 500 mg three times a day for 10 to 14 days - Vancomycin 125 mg four times a day for 10 to 14 days - Is pregnant - Has taken oral or IV steroids in the past three months. - Has taken biologic agents, anti-TNF agents, cyclosporine, mercaptopurine, azathioprine, methotrexate or chemotherapy in the preceding 3 months - Has profound immunosuppression: Chemotherapy the preceding 3 months, HIV/AIDS, decompensated cirrhosis - In the Intensive Care Unit - Is a transplant recipient


NCT ID:

NCT02326636


Primary Contact:

Principal Investigator
Nimisha Parekh, MD
University of California, Irvine

Douglas O'Connell, MS
Phone: 7144567033
Email: Douglaeo@uci.edu


Backup Contact:

Email: sentelle@uci.edu
Sentelle Eubanks
Phone: 7144562215


Location Contact:

Orange, California 92868
United States

Douglas O'Connell, MS
Phone: 714-456-7033
Email: Douglaeo@uci.edu

Site Status: Recruiting


Data Source: ClinicalTrials.gov

Date Processed: November 21, 2017

Modifications to this listing: Only selected fields are shown, please use the link below to view all information about this clinical trial.


Click to view Full Listing

If you would like to be contacted by the clinical trial representative please fill out the form below.