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

Cancer Clinical Trial

Official title:

Safety of Fecal Microbiota Transplantation (FMT) for Recurrent or Refractory C. Difficile Infection in Patients With Solid Tumors

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02770326
• Other study ID #: 15-337
• Status: Completed
• Phase: N/A
• Start date: May 10, 2016
• Est. completion date: February 16, 2024

Study information

• Verified date: February 2024
• Source: Memorial Sloan Kettering Cancer Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 10
• Est. completion date: February 16, 2024
• Est. primary completion date: February 16, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• C. Difficile Infection
• Cancer
• Communicable Diseases
• Infections

Intervention

Biological:
• Fecal Microbiota Transplantation (FMT)

Locations

Country	Name	City	State
United States	Memorial Sloan Kettering Cancer Center	New York	New York

Sponsors (1)

Lead Sponsor	Collaborator
Memorial Sloan Kettering Cancer Center

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Evaluate safety based the number of infections	Safety will be assessed by monitoring two types of infections that occur within 2 weeks of the FMT procedure.	2 weeks after the FMT

External Links

•   Memorial Sloan Kettering Cancer Center