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

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
• Conditions: Cancer; C. Difficile Infection
• Intervention / Treatment: Biological: Fecal Microbiota Transplantation (FMT)

• Study Type: Interventional
• Enrollment (Actual): 10
• Phase: Not Applicable

Contacts and Locations

Study Locations

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

Participation Criteria

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

How is the study designed?

Design Details

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

Number of Arms

1

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.

Biological: Fecal Microbiota Transplantation (FMT)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of Participants Evaluated for Infection During Treatment Intervention	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

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

Publications and helpful links

Helpful Links

• Memorial Sloan Kettering Cancer Center

Study record dates

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 (Actual): April 8, 2025
• Last Update Submitted That Met QC Criteria: March 19, 2025
• Last Verified: February 1, 2024

More Information

Terms related to this study

• Keywords: Safety of Stool Transplant; Fecal Microbiota Transplantation (FMT); 15-337
• Additional Relevant MeSH Terms: Pathologic Processes; Disease Attributes; Infections; Communicable Diseases
• Other Study ID Numbers: 15-337