Skip to main content
OpenTrials
Completed

NCT Number: NCT02326636

Fecal Microbiota Transplant for Recurrent Clostridium Difficile Infection

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.

Completed

Looking for future studies?

Notify Me

Key information

Age range

18 year–100 year

Sex eligibility

All sexes

Study type

Observational

Primary location

University of California, Irvine Medical Center

Orange, California, 92868, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Fecal Microbial Transplantation

Biological

Participants with refractory Clostridium difficile infection will be given healthy donor stool administered by colonoscopy or enema.

Primary outcomes

  1. The recurrence rate of Clostridium difficile 4 weeks after FMT.

    Time frame: Four weeks

Secondary outcomes

  1. Clinical symptoms from before fecal microbiota transplant (FMT) to 4 weeks after FMT.

    Time frame: Four weeks

  2. Satisfaction with the FMT procedure. ( satisfaction questionnaire )

    Time frame: Up to 24 weeks

    Subjects will complete a satisfaction questionnaire following the FMT procedure.

  3. 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.

  4. 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.

  5. The rate of adverse events that may be related to FMT.

    Time frame: Up to 24 weeks

Sponsors and collaborators

Lead sponsor

University of California, Irvine

Other

Registry information

Acronym: FMT

Important dates

Study start
2014
Primary completion
2018
Study completion
2018
First posted
Dec 29, 2014
Registry last updated
Aug 21, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.