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NCT02770326 | COMPLETED | C. Difficile Infection

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

Memorial Sloan Kettering Cancer Center

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.

Condition or disease

C. Difficile Infection

Cancer

Intervention/treatment

Fecal Microbiota Transplantation (FMT)

Phase

NA

Study Type : INTERVENTIONAL
Estimated Enrollment : 10 participants
Masking : NONE
Primary Purpose : TREATMENT
Official Title : Safety of Fecal Microbiota Transplantation (FMT) for Recurrent or Refractory C. Difficile Infection in Patients With Solid Tumors
Actual Study Start Date : 2016-05-10
Estimated Primary Completion Date : 2024-02-16
Estimated Study Completion Date : 2024-02-16

Information not available for Arms and Intervention/treatment

Ages Eligible for Study: 18 Years
Sexes Eligible for Study: ALL
Accepts Healthy Volunteers:
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
Safety of Stool Transplant for Patients With Difficult to Treat C. Difficile Infection

Location Details

NCT02770326

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How to Participate

Want to participate in this study, select a site at your convenience, send yourself email to get contact details and prescreening steps.

Locations

Not yet recruiting

United States, New York

Memorial Sloan Kettering Cancer Center

New York, New York, United States, 10065