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

This study is currently recruiting participants. (see Contacts and Locations)
Verified March 2017 by Memorial Sloan Kettering Cancer Center
Sponsor:
Information provided by (Responsible Party):
Memorial Sloan Kettering Cancer Center
ClinicalTrials.gov Identifier:
NCT02770326
First received: May 11, 2016
Last updated: March 28, 2017
Last verified: March 2017
  Purpose
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 Intervention
C. Difficile Infection
Cancer
Biological: Fecal Microbiota Transplantation (FMT)

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: No masking
Primary Purpose: Treatment
Official Title: Safety of Fecal Microbiota Transplantation (FMT) for Recurrent or Refractory C. Difficile Infection in Patients With Solid Tumors

Resource links provided by NLM:


Further study details as provided by Memorial Sloan Kettering Cancer Center:

Primary Outcome Measures:
  • 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.


Estimated Enrollment: 15
Actual Study Start Date: May 10, 2016
Estimated Study Completion Date: May 2018
Estimated Primary Completion Date: May 2018 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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)

  Eligibility

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
    • Patients receiving immunotherapy, as colitis is a known adverse event of this therapy
  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02770326

Contacts
Contact: Robin B Mendelsohn, MD 212-639-8152
Contact: Anna Kaltsas, MD 212-639-7809

Locations
United States, New York
Memorial Sloan Kettering Cancer Center Recruiting
New York, New York, United States, 10065
Contact: Robin Mendelsohn, MD    212-639-8152      
Contact: Anna Kaltsas, MD    212-639-7809      
Sponsors and Collaborators
Memorial Sloan Kettering Cancer Center
Investigators
Principal Investigator: Robin B. Mendelsohn, MD Memorial Sloan Kettering Cancer Center
  More Information

Additional Information:
Responsible Party: Memorial Sloan Kettering Cancer Center
ClinicalTrials.gov Identifier: NCT02770326     History of Changes
Other Study ID Numbers: 15-337
Study First Received: May 11, 2016
Last Updated: March 28, 2017

Keywords provided by Memorial Sloan Kettering Cancer Center:
Safety of Stool Transplant
Fecal Microbiota Transplantation (FMT)
15-337

Additional relevant MeSH terms:
Infection
Communicable Diseases

ClinicalTrials.gov processed this record on March 29, 2017