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Fecal Microbiota Transplantation for C. Difficile Infection in Solid Organ Transplant Recipients

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. Identifier: NCT03617445
Recruitment Status : Not yet recruiting
First Posted : August 6, 2018
Last Update Posted : March 4, 2019
Information provided by (Responsible Party):
University of Wisconsin, Madison

Brief Summary:
The objective is to examine the effect of Fecal Microbiota Transplantation (FMT) compared with vancomycin for cure of recurrent C. diff infection (CDI) in solid organ transplant (SOT) recipients in a randomized, controlled clinical trial.

Condition or disease Intervention/treatment Phase
Clostridium Difficile Infection Recurrence Drug: FMT enema Drug: Oral Vancomycin Drug: FMT enema placebo Drug: Oral Vancomycin placebo Phase 2

Detailed Description:
Clostridium difficile (C.difficile) is a pathogen of major public health importance,especially in individuals with comorbid conditions such as solid organ transplantation(SOT). The incidence and adverse outcomes of CDI are greatly amplified in the setting of SOT, due to healthcare exposure, antibiotic use and immunosuppression, all of which are ubiquitous in SOT recipients. There are currently no effective treatment options to achieve a sustained cure of recurrent CDI and prevent further recurrence in SOT recipients. A novel approach that has recently gained attention is restoration of the CDI impaired gut microbiome by instillation of stool from a healthy donor into the intestine of a CDI patient. This treatment, called Fecal Microbiota Transplantation (FMT) has been found in non-comparative studies to reduce CDI recurrence dramatically with a reported efficacy of over 95%, however its efficacy in SOT recipients has not been studied and cannot be extrapolated from results in the non-SOT population because SOT recipients are a unique study population due to profound immunosuppression, frequent antibiotic use and frequent opportunities for exposure to CDI all of which markedly, repeatedly and persistently disrupt the gut microbiome. Thus, this critical gap in the field needs to be addressed by a trial of FMT in SOT recipients with CDI.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 158 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: This is a phase 2, double blind, double dummy, randomized, placebo controlled trial assessing the treatment effects of FMT compared to oral Vancomycin for recurrent CDI in solid organ transplant recipients.
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Fecal Microbiota Transplantation for C. Difficile Infection in Solid Organ Transplant Recipients
Estimated Study Start Date : March 31, 2019
Estimated Primary Completion Date : December 31, 2023
Estimated Study Completion Date : December 31, 2023

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Bowel Movement

Arm Intervention/treatment
Active Comparator: FMT enema/ oral vancomycin placebo
FMT plus placebo vancomycin
Drug: FMT enema
FMT enema one time
Other Name: FMP250

Drug: Oral Vancomycin placebo
Placebo oral vancomycin capsules every 6 hours for 14 days
Other Name: placebo

Active Comparator: Placebo FMT/ Active oral vancomycin
Vancomycin plus FMT enema placebo
Drug: Oral Vancomycin
Oral Vancomycin 125 mg capsules every 6 hours for 14 days
Other Name: vancomycin

Drug: FMT enema placebo
FMT placebo one time
Other Name: Placebo FMP250

Primary Outcome Measures :
  1. Compare the rate of recurrence of CDI in solid organ transplant recipients with FMT compared with oral vancomycin [ Time Frame: 2 consecutive days ]
    Recurrence is defined as diarrhea (3 or more loose stools in a 24 hr period)

Secondary Outcome Measures :
  1. CDI-related QOL [ Time Frame: At baseline, week 4 and at 24 weeks ]
    Cdiff 32

  2. Compare the change in gut microbiota and evaluate the association between the change in gut microbiota and recurrence of CDI [ Time Frame: up to 24 weeks of study participation ]
    Using multiple metric of microbiota structure and function

  3. Evaluate the short- and medium-term safety of FMT delivered via enema in SOT patients [ Time Frame: Up 24 weeks of study participation ]
    Closely follow safety events

  4. Compare the effects of FMT and oral vancomycin on intestinal colonization by multi-drug-resistant organisms other than C. difficile in SOT patients [ Time Frame: up to 24 weeks of study participation ]
    Analysis of stool samples

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Is able to provide written informed consent
  • Is a solid organ transplant (SOT) recipient
  • Has had at least a first recurrence of C. difficile infection defined as: positive C. difficile testing in stool and diarrhea (three or more loose stools over 24 hours) during the 60 day period following completion of treatment for prior episode.
  • No more than 3 CDI recurrences
  • Negative pregnancy test for women of childbearing potential and agree to use effective form of contraception until 6 weeks post treatment
  • Clinical response to 4-7 days of oral antibiotic standard of care treatment for the current episode of CDI

Exclusion Criteria:

  • Has a history of chronic or active intestinal disease (e.g. Crohn's disease, ulcerative colitis)
  • Is unable to complete a daily stool diary (mental incapacity, head trauma, etc.)
  • Has presence of toxic megacolon or ileus
  • Has presence of colostomy
  • Is enrolled in another investigational drug trial
  • Is severely immunocompromised (≥ 80 or more mg of prednisone or equivalent daily)
  • Is unavailable for follow-up visits
  • Is taking concomitant antibiotics at time of enrollment for anything other than for treatment of current CDI
  • Is taking probiotics at enrollment and unwilling to discontinue
  • Has received an investigational product or been treated with an investigational device within 30 days prior to visit #1
  • Co-infection with another intestinal pathogen

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT03617445

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Contact: Shelly Zimbric, BS 608-265-8799
Contact: Shari Zeldin, BS,CCRC,CCRA 608-262-0278

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United States, Wisconsin
University of Wisconsin Hospital & Clinics Not yet recruiting
Madison, Wisconsin, United States, 53792
Sponsors and Collaborators
University of Wisconsin, Madison
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Principal Investigator: Nasia Safdar, MD, PhD University of Wisconsin, Madison

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Responsible Party: University of Wisconsin, Madison Identifier: NCT03617445     History of Changes
Other Study ID Numbers: 2018-1056
First Posted: August 6, 2018    Key Record Dates
Last Update Posted: March 4, 2019
Last Verified: February 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
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Communicable Diseases
Clostridium Infections
Gram-Positive Bacterial Infections
Bacterial Infections
Disease Attributes
Pathologic Processes
Anti-Bacterial Agents
Anti-Infective Agents