N/A
Completed N=10
Safety of Stool Transplant for Patients With Difficult to Treat C. Difficile Infection
C. Difficile Infection · Cancer
Source: ClinicalTrials.gov NCT02770326 ↗
Enrolled (actual)
10
Serious AEs
0.0%
Results posted
Apr 2025
Primary outcomePrimary: Number of Participants Evaluated for Infection During Treatment Intervention — 10 Participants
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants Evaluated for Infection During Treatment Intervention |
10 | — |
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 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
Data sourced from ClinicalTrials.gov (NCT02770326). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.