Fecal Microbiota Transplant for Recurrent Clostridium Difficile Infection

Study Overview
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Brief Summary
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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.

Official Title
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Fecal Microbiota Transplant for Recurrent Clostridium Difficile Infection

Conditions
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Clostridium Difficile Infection

Intervention / Treatment
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* Biological: Fecal Microbial Transplantation


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 100 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Intervention/Treatment |
| --- |
|Biological: Fecal Microbial Transplantation|Participants with refractory Clostridium difficile infection will be given healthy donor stool administered by colonoscopy or enema.|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The recurrence rate of Clostridium difficile 4 weeks after FMT. |  | Four weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Clinical symptoms from before fecal microbiota transplant (FMT) to 4 weeks after FMT. |  | Four weeks | 
| Satisfaction with the FMT procedure. ( satisfaction questionnaire ) | Subjects will complete a satisfaction questionnaire following the FMT procedure. | Up to 24 weeks | 
| Quality of life before and 4 weeks after FMT. | Subjects will complete a quality of life questionnaire before and 4 weeks after FMT. | Four weeks | 
| Alternate treatments needed for Clostridium difficile before and after FMT. | Subjects medication and treatment history for Clostridium difficile before and after FMT will be collected. | Up to 24 weeks | 
| The rate of adverse events that may be related to FMT. |  | Up to 24 weeks |