Fecal Microbiota Transplant for Recurrent Clostridium Difficile Infection
| Status: | Completed |
|---|---|
| Conditions: | Infectious Disease |
| Therapuetic Areas: | Immunology / Infectious Diseases |
| Healthy: | No |
| Age Range: | 18 - Any |
| Updated: | 4/2/2016 |
| Start Date: | April 2014 |
| End Date: | April 2016 |
| Contact: | Yuna K Muyshondt, MPH |
| Email: | chuny@uci.edu |
| Phone: | 7144562215 |
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.
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.
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
We found this trial at
1
site
101 The City Drive South
Orange, California 92868
Orange, California 92868
714-456-7890
University of California, Irvine Medical Center We are UC Irvine Health. We are a devoted...
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