Fecal Microbiota Transplant for Recurrent Clostridium Difficile Infection (FMT)

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.

Study Overview

• Status: Completed
• Conditions: Clostridium Difficile Infection
• Intervention / Treatment: Biological: Fecal Microbial Transplantation

• Study Type: Observational
• Enrollment (Actual): 37

Contacts and Locations

Study Locations

• United States
  • California
    • Orange, California, United States, 92868
      • University of California, Irvine Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 100 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Patients who are referred for recurrent Clostridium difficile infections. Donors will be identified by the Recipient.

Description

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

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Collaborators and Investigators

• Sponsor: University of California, Irvine
• Investigators: Principal Investigator: Nimisha Parekh, MD, University of California, Irvine

Study record dates

Study Major Dates

• Study Start: April 1, 2014
• Primary Completion (Actual): October 26, 2018
• Study Completion (Actual): October 26, 2018

Study Registration Dates

• First Submitted: December 9, 2014
• First Submitted That Met QC Criteria: December 26, 2014
• First Posted (Estimated): December 29, 2014

Study Record Updates

• Last Update Posted (Actual): August 21, 2023
• Last Update Submitted That Met QC Criteria: August 16, 2023
• Last Verified: August 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Disease Attributes; Bacterial Infections; Bacterial Infections and Mycoses; Gram-Positive Bacterial Infections; Infections; Communicable Diseases; Clostridium Infections
• Other Study ID Numbers: 20139455; 2013-9455 (OTHER: UC Irvine Institutional Review Board)