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

NCT02770326 | Completed Results

• 1 other identifier: 15-337
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

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.

Conditions

C. Difficile Infection; Cancer

Keywords

Safety of Stool Transplant; Fecal Microbiota Transplantation (FMT); 15-337

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (1)

Fecal Microbiota Transplantation (FMT)

EXPERIMENTAL

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)

Interventions

Fecal Microbiota Transplantation (FMT) BIOLOGICAL

Fecal Microbiota Transplantation (FMT)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• ≥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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Memorial Sloan Kettering Cancer Center: lead

Study Sites (1)

Memorial Sloan Kettering Cancer Center

New York, New York, 10065, United States

Location

Related Links

• Memorial Sloan Kettering Cancer Center

MeSH Terms

Conditions

Neoplasms

Interventions

Fecal Microbiota Transplantation

Intervention Hierarchy (Ancestors)

Biological Therapy; Therapeutics

Results Point of Contact

• Title: Dr. Robin Mendelsohn, MD
• Organization: Memorial Sloan Kettering Cancer Center

mendelsr@mskcc.org

212-639-8286

Study Officials

• Robin B. Mendelsohn, MD

  Memorial Sloan Kettering Cancer Center

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 11, 2016
• First Posted: May 12, 2016
• Study Start: May 10, 2016
• Primary Completion: February 16, 2024
• Study Completion: February 16, 2024
• Last Updated: April 8, 2025
• Results First Posted: April 8, 2025

Record last verified: 2024-02

Locations

US (1)