Fecal Microbiota Transplant for Recurrent Clostridium Difficile Infection (FMT)

University of California Irvine (UCI)

Status: Completed

Conditions: Clostridium Difficile Infection

Treatments: Biological: Fecal Microbial Transplantation

Study type: Observational

Funder types: Other

Identifiers

NCT02326636

20139455

Details and patient eligibility

About

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.

Enrollment: 37 patients

Sex: All

Ages: 18 to 100 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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