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

Primary Purpose

C. Difficile Infection, Cancer

Status
Active
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Fecal Microbiota Transplantation (FMT)
Sponsored by
Memorial Sloan Kettering Cancer Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for C. Difficile Infection focused on measuring Safety of Stool Transplant, Fecal Microbiota Transplantation (FMT), 15-337

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Memorial Sloan Kettering Cancer Center

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Fecal Microbiota Transplantation (FMT)

Arm Description

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.

Outcomes

Primary Outcome Measures

Evaluate safety based the number of infections
Safety will be assessed by monitoring two types of infections that occur within 2 weeks of the FMT procedure.

Secondary Outcome Measures

Full Information

First Posted
May 11, 2016
Last Updated
June 1, 2023
Sponsor
Memorial Sloan Kettering Cancer Center
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1. Study Identification

Unique Protocol Identification Number
NCT02770326
Brief Title
Safety of Stool Transplant for Patients With Difficult to Treat C. Difficile Infection
Official Title
Safety of Fecal Microbiota Transplantation (FMT) for Recurrent or Refractory C. Difficile Infection in Patients With Solid Tumors
Study Type
Interventional

2. Study Status

Record Verification Date
June 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
May 10, 2016 (Actual)
Primary Completion Date
May 2025 (Anticipated)
Study Completion Date
May 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Memorial Sloan Kettering Cancer Center

4. Oversight

5. Study Description

Brief Summary
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
C. Difficile Infection, Cancer
Keywords
Safety of Stool Transplant, Fecal Microbiota Transplantation (FMT), 15-337

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
10 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Fecal Microbiota Transplantation (FMT)
Arm Type
Experimental
Arm Description
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.
Intervention Type
Biological
Intervention Name(s)
Fecal Microbiota Transplantation (FMT)
Primary Outcome Measure Information:
Title
Evaluate safety based the number of infections
Description
Safety will be assessed by monitoring two types of infections that occur within 2 weeks of the FMT procedure.
Time Frame
2 weeks after the FMT

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Robin B. Mendelsohn, MD
Organizational Affiliation
Memorial Sloan Kettering Cancer Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Memorial Sloan Kettering Cancer Center
City
New York
State/Province
New York
ZIP/Postal Code
10065
Country
United States

12. IPD Sharing Statement

Links:
URL
https://www.mskcc.org/
Description
Memorial Sloan Kettering Cancer Center

Learn more about this trial

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

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