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

NCT ID: NCT02770326

Last Updated: 2025-04-08

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 10 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-05-10
• Study Completion Date: 2024-02-16

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

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

Fecal Microbiota Transplantation (FMT)

Intervention Type: BIOLOGICAL

Interventions

Fecal Microbiota Transplantation (FMT)

Intervention Type: BIOLOGICAL

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Memorial Sloan Kettering Cancer Center

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Robin B. Mendelsohn, MD

Role: PRINCIPAL_INVESTIGATOR

Memorial Sloan Kettering Cancer Center

Locations

Memorial Sloan Kettering Cancer Center

New York, New York, United States

Countries

United States

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Related Links

https://www.mskcc.org/

Memorial Sloan Kettering Cancer Center

Other Identifiers

15-337

Identifier Type: -

Identifier Source: org_study_id