Clinical trial NCT02326636: Fecal Microbiota Transplant for Recurrent Clostridium Difficile Infection
Official title: Fecal Microbiota Transplant for Recurrent Clostridium Difficile Infection
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Clostridium Difficile Infection
Lead sponsor: University of California, Irvine
Sponsor class: OTHER
First posted: 2014-12-29
Enrollment: 37
Sex: ALL
Minimum age (years): 18
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients who are referred for recurrent Clostridium difficile infections. Donors will be identified by the Recipient.

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.


Eligibility 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

Primary outcomes:
measure: The recurrence rate of Clostridium difficile 4 weeks after FMT.
timeFrame: Four weeks
Secondary outcomes:
measure: Clinical symptoms from before fecal microbiota transplant (FMT) to 4 weeks after FMT.
timeFrame: Four weeks
measure: Satisfaction with the FMT procedure. ( satisfaction questionnaire )
timeFrame: Up to 24 weeks
measure: Quality of life before and 4 weeks after FMT.
timeFrame: Four weeks
measure: Alternate treatments needed for Clostridium difficile before and after FMT.
timeFrame: Up to 24 weeks
measure: The rate of adverse events that may be related to FMT.
timeFrame: Up to 24 weeks
Other outcomes:
Locations:
city: Orange
country: United States
facility: University of California, Irvine Medical Center
state: California
Study officials:
affiliation: University of California, Irvine
name: Nimisha Parekh, MD
role: PRINCIPAL_INVESTIGATOR
References: