Safety of Stool Transplant for Patients With Difficult to Treat C. Difficile Infection

February 20, 2024 updated by: Memorial Sloan Kettering Cancer Center

Safety of Fecal Microbiota Transplantation (FMT) for Recurrent or Refractory C. Difficile Infection in Patients With Solid Tumors

The purpose of this study is to test the safety of FMT in patients with C. difficile and cancer. In previous other studies, FMT has been shown to cure C. difficile when antibiotics have failed, but most of these studies have not included patients with cancer. The investigators want to prove that FMT is safe in this group of people so that doctors will feel more comfortable prescribing it for their patients with cancer.

Study Overview

Status

Completed

Study Type

Interventional

Enrollment (Actual)

10

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

    • New York
      • New York, New York, United States, 10065
        • Memorial Sloan Kettering Cancer Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • ≥18 years old
  • Patients with solid organ malignancy who have received chemotherapy within the past six months.
  • Clinical and microbiologic relapse of C. difficile associated diarrhea after at least one course of adequate antibiotic therapy or refractory disease that does not respond to treatment.

    • At least 10 days of vancomycin at least 125mg QID, or metronidazole 500mg TID
    • C. difficile associated diarrhea is defined as: ≥3 loose or watery stools per day for at least 2 consecutive days or ≥8 loose stools in 48 hours and Positive Clostridium difficile PCR
  • Life expectancy of >3 months.

Exclusion Criteria:

  • Expected prolonged compromised immunity

    • HIV infection with CD4 count <240
    • History of hematopoietic stem cell transplant (HSCT)
    • Hematologic malignancy
    • ANC <1000/mm3
  • Contraindications to anesthesia for procedure

    • Serious cardiopulmonary comorbidities
    • Inability to tolerate anesthesia
    • HGB <8 g/dL
  • Risk of bleeding during procedure

    • PLT <50,000 K/mcL
    • INR >1.5 INR
  • Pregnancy

    o Pregnant patients will be excluded from this study.

  • Gastrointestinal (GI) contraindications

    • Inflammatory bowel disease
    • Active fistula
    • Small bowel obstruction
    • Ileus
    • Gastroparesis
    • Nausea and vomiting
    • Gastrointestinal surgery within the previous 3 months

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Fecal Microbiota Transplantation (FMT)
Patients with recurrent or refractory CDI who meet study eligibility criteria, will consent to undergo either colonoscopy or upper endoscopy with infusion of stool admixture. Safety will be assessed by monitoring infections that occurred within 2 weeks of the FMT procedures. Additionally, 24-hours, 1 week, 2 weeks, 4 weeks, and 6 months post-FMT, a stool sample will be collected. The time window for each time point listed is +/- 48 hours, with the exception of the first, 24 hour, time point. The time window for the 24 hour time point is +48 hours post FMT.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Evaluate safety based the number of infections
Time Frame: 2 weeks after the FMT
Safety will be assessed by monitoring two types of infections that occur within 2 weeks of the FMT procedure.
2 weeks after the FMT

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Principal Investigator: Robin B. Mendelsohn, MD, Memorial Sloan Kettering Cancer Center

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 10, 2016

Primary Completion (Actual)

February 16, 2024

Study Completion (Actual)

February 16, 2024

Study Registration Dates

First Submitted

May 11, 2016

First Submitted That Met QC Criteria

May 11, 2016

First Posted (Estimated)

May 12, 2016

Study Record Updates

Last Update Posted (Estimated)

February 22, 2024

Last Update Submitted That Met QC Criteria

February 20, 2024

Last Verified

February 1, 2024

More Information

Terms related to this study

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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