CClinicalTrials.gg
Sign In
CompletedNCT02326636FMTUpdated Aug 21, 2023

Fecal Microbiota Transplant for Recurrent Clostridium Difficile Infection

An observational study in Clostridium Difficile Infection, sponsored by University of California, Irvine. Completed at 1 site in United States. Open to participants aged 18 Years to 100 Years. Per ClinicalTrials.gov, last updated 2023-08-21.

Sponsored by University of California, Irvine · Observational

Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
37
Ages
18 Years to 100 Years
Sex
All
01

Study 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.

02

Conditions studied

  • Clostridium Difficile Infection
03

In context

Infections

6,687 studies on the registry are indexed under Infections; 807 are open to participants now.

This study's enrollment of 37 is below the median of 240 across 2,136 observational studies indexed under Infections.

Browse Infections studies →

Lead sponsor

University of California, Irvine is the lead sponsor of 466 studies on the registry; 96 are open to participants now.

Of its 41 completed or terminated interventional studies of FDA-regulated products, 30 (73%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 100 Years
Sexes eligible
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.

Inclusion criteria

  • 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

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
05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
37 participants (actual)
Patient registry
No
Biospecimen retention
Samples without dna

Interventions

  • BiologicalFecal Microbial Transplantation

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

06

What researchers measure

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 )

    Subjects will complete a satisfaction questionnaire following the FMT procedure.

    Time frame: Up to 24 weeks

  3. Quality of life before and 4 weeks after FMT.

    Subjects will complete a quality of life questionnaire before and 4 weeks after FMT.

    Time frame: Four weeks

  4. 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.

    Time frame: Up to 24 weeks

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

    Time frame: Up to 24 weeks

07

Study locations

1 site
  • University of California, Irvine Medical Center
    Orange, California 92868, United States
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Aug 21, 2023, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT02326636
Lead sponsor
University of California, Irvine
Responsible party
Nimisha Parekh (Associate Clinical Professor, University of California, Irvine) — Principal investigator
First posted
Dec 29, 2014
Start date
Apr 2014
Primary completion
Oct 26, 2018
Completion
Oct 26, 2018
Last update
Aug 21, 2023

Study contacts

Nimisha Parekh, MD
principal investigator · University of California, Irvine

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Aug 2023. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Other studies in this condition

Infections→

Other studies from this sponsor

University of California, Irvine

Start the discussion