Clostridium Difficile Infection
Conditions
Brief summary
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.
Interventions
BIOLOGICALFecal Microbial Transplantation
Participants with refractory Clostridium difficile infection will be given healthy donor stool administered by colonoscopy or enema.
Sponsors
University of California, Irvine
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to 100 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The recurrence rate of Clostridium difficile 4 weeks after FMT. | Four weeks |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| The rate of adverse events that may be related to FMT. | Up to 24 weeks | — |
| Clinical symptoms from before fecal microbiota transplant (FMT) to 4 weeks after FMT. | Four weeks | — |
| Satisfaction with the FMT procedure. ( satisfaction questionnaire ) | Up to 24 weeks | Subjects will complete a satisfaction questionnaire following the FMT procedure. |
| Quality of life before and 4 weeks after FMT. | Four weeks | Subjects will complete a quality of life questionnaire before and 4 weeks after FMT. |
| Alternate treatments needed for Clostridium difficile before and after FMT. | Up to 24 weeks | Subjects medication and treatment history for Clostridium difficile before and after FMT will be collected. |
Countries
United States
Outcome results
None listed