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

Study Overview
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Brief Summary
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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.

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

Conditions
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Cancer, C. Difficile Infection

Intervention / Treatment
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* Biological: Fecal Microbiota Transplantation (FMT)


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Fecal Microbiota Transplantation (FMT)<br>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)<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Safety of Stool Transplant, Fecal Microbiota Transplantation (FMT), 15-337