Cancer, C. Difficile Infection
Conditions
Keywords
Safety of Stool Transplant, Fecal Microbiota Transplantation (FMT), 15-337
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.
Interventions
BIOLOGICALFecal Microbiota Transplantation (FMT)
Sponsors
Memorial Sloan Kettering Cancer Center
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants Evaluated for Infection During Treatment Intervention | 2 weeks after the FMT | Safety will be assessed by monitoring two types of infections that occur within 2 weeks of the FMT procedure. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Fecal Microbiota Transplantation (FMT) 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.
Fecal Microbiota Transplantation (FMT) | 10 |
| Total | 10 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Death | 3 |
| Overall Study | Lost to Follow-up | 1 |
Baseline characteristics
| Characteristic | Fecal Microbiota Transplantation (FMT) |
|---|---|
| Age, Continuous | 67 years |
| Ethnicity (NIH/OMB) Hispanic or Latino | 0 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 10 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 1 Participants |
| Race (NIH/OMB) Asian | 1 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants |
| Race (NIH/OMB) More than one race | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 1 Participants |
| Race (NIH/OMB) White | 7 Participants |
| Region of Enrollment United States | 10 Participants |
| Sex: Female, Male Female | 6 Participants |
| Sex: Female, Male Male | 4 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 7 / 10 |
| other Total, other adverse events | 10 / 10 |
| serious Total, serious adverse events | 0 / 10 |
Outcome results
Primary
Number of Participants Evaluated for Infection During Treatment Intervention
Safety will be assessed by monitoring two types of infections that occur within 2 weeks of the FMT procedure.
Time frame: 2 weeks after the FMT
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Fecal Microbiota Transplantation (FMT) | Number of Participants Evaluated for Infection During Treatment Intervention | 10 Participants |