Safety of Stool Transplant for Patients With Difficult to Treat C. Difficile Infection
| Status: | Recruiting |
|---|---|
| Conditions: | Cancer, Cancer, Infectious Disease |
| Therapuetic Areas: | Immunology / Infectious Diseases, Oncology |
| Healthy: | No |
| Age Range: | 18 - Any |
| Updated: | 2/28/2019 |
| Start Date: | May 10, 2016 |
| End Date: | May 2019 |
| Contact: | Robin B Mendelsohn, MD |
| Phone: | 212-639-8152 |
Safety of Fecal Microbiota Transplantation (FMT) for Recurrent or Refractory C. Difficile Infection in Patients With Solid Tumors
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.
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.
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
We found this trial at
1
site
1275 York Ave
New York, New York 10021
New York, New York 10021
(212) 639-2000
Phone: 212-639-8152
Memorial Sloan Kettering Cancer Center Memorial Sloan Kettering Cancer Center — the world's oldest and...
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