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Fecal Microbiota Transplant for Recurrent Clostridium Difficile Infection (FMT)

This study is currently recruiting participants.
See Contacts and Locations
Verified October 2016 by Nimisha Parekh, University of California, Irvine
Sponsor:
Information provided by (Responsible Party):
Nimisha Parekh, University of California, Irvine
ClinicalTrials.gov Identifier:
NCT02326636
First received: December 9, 2014
Last updated: October 25, 2016
Last verified: October 2016
  Purpose
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.

Condition Intervention
Clostridium Difficile Infection Biological: Fecal Microbial Transplantation

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Fecal Microbiota Transplant for Recurrent Clostridium Difficile Infection

Resource links provided by NLM:


Further study details as provided by Nimisha Parekh, University of California, Irvine:

Primary Outcome Measures:
  • The recurrence rate of Clostridium difficile 4 weeks after FMT. [ Time Frame: Four weeks ]

Secondary Outcome Measures:
  • Clinical symptoms from before fecal microbiota transplant (FMT) to 4 weeks after FMT. [ Time Frame: Four weeks ]
  • Satisfaction with the FMT procedure. ( satisfaction questionnaire ) [ Time Frame: Up to 24 weeks ]
    Subjects will complete a satisfaction questionnaire following the FMT procedure.

  • Quality of life before and 4 weeks after FMT. [ Time Frame: 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. [ Time Frame: Up to 24 weeks ]
    Subjects medication and treatment history for Clostridium difficile before and after FMT will be collected.

  • The rate of adverse events that may be related to FMT. [ Time Frame: Up to 24 weeks ]

Biospecimen Retention:   Samples Without DNA
A donor stool sample will be kept for future testing in case of contamination.

Estimated Enrollment: 76
Study Start Date: April 2014
Estimated Study Completion Date: May 2018
Estimated Primary Completion Date: December 2017 (Final data collection date for primary outcome measure)
Intervention Details:
    Biological: Fecal Microbial Transplantation
    Participants with refractory Clostridium difficile infection will be given healthy donor stool administered by colonoscopy or enema.
  Eligibility

Ages Eligible for Study:   18 Years to 100 Years   (Adult, Senior)
Sexes Eligible for Study:   All
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.
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02326636

Contacts
Contact: Douglas O'Connell, MS 7144567033 Douglaeo@uci.edu
Contact: Sentelle Eubanks 7144562215 sentelle@uci.edu

Locations
United States, California
University of California, Irvine Medical Center Recruiting
Orange, California, United States, 92868
Contact: Douglas O'Connell, MS    714-456-7033    Douglaeo@uci.edu   
Sponsors and Collaborators
University of California, Irvine
Investigators
Principal Investigator: Nimisha Parekh, MD University of California, Irvine
  More Information

Responsible Party: Nimisha Parekh, Associate Clinical Professor, University of California, Irvine
ClinicalTrials.gov Identifier: NCT02326636     History of Changes
Other Study ID Numbers: UCaliforniaIrvine
2013-9455 ( Other Identifier: UC Irvine Institutional Review Board )
Study First Received: December 9, 2014
Last Updated: October 25, 2016

Additional relevant MeSH terms:
Infection
Communicable Diseases

ClinicalTrials.gov processed this record on July 26, 2017