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

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. Read our disclaimer for details. Identifier: NCT02770326
Recruitment Status : Active, not recruiting
First Posted : May 12, 2016
Last Update Posted : January 27, 2020
Information provided by (Responsible Party):
Memorial Sloan Kettering Cancer Center

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.

Condition or disease Intervention/treatment Phase
C. Difficile Infection Cancer Biological: Fecal Microbiota Transplantation (FMT) Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 10 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Safety of Fecal Microbiota Transplantation (FMT) for Recurrent or Refractory C. Difficile Infection in Patients With Solid Tumors
Actual Study Start Date : May 10, 2016
Estimated Primary Completion Date : May 2021
Estimated Study Completion Date : May 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Bowel Movement

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.
Biological: Fecal Microbiota Transplantation (FMT)

Primary Outcome Measures :
  1. 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.

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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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:

  • ≥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

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): NCT02770326

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United States, New York
Memorial Sloan Kettering Cancer Center
New York, New York, United States, 10065
Sponsors and Collaborators
Memorial Sloan Kettering Cancer Center
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Principal Investigator: Robin B. Mendelsohn, MD Memorial Sloan Kettering Cancer Center
Additional Information:
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Responsible Party: Memorial Sloan Kettering Cancer Center Identifier: NCT02770326    
Other Study ID Numbers: 15-337
First Posted: May 12, 2016    Key Record Dates
Last Update Posted: January 27, 2020
Last Verified: January 2020
Keywords provided by Memorial Sloan Kettering Cancer Center:
Safety of Stool Transplant
Fecal Microbiota Transplantation (FMT)
Additional relevant MeSH terms:
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Communicable Diseases