- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02770326
Safety of Stool Transplant for Patients With Difficult to Treat C. Difficile Infection
Safety of Fecal Microbiota Transplantation (FMT) for Recurrent or Refractory C. Difficile Infection in Patients With Solid Tumors
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
New York
-
New York, New York, United States, 10065
- Memorial Sloan Kettering Cancer Center
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: 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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Evaluate safety based the number of infections
Time Frame: 2 weeks after the FMT
|
Safety will be assessed by monitoring two types of infections that occur within 2 weeks of the FMT procedure.
|
2 weeks after the FMT
|
Collaborators and Investigators
Investigators
- Principal Investigator: Robin B. Mendelsohn, MD, Memorial Sloan Kettering Cancer Center
Publications and helpful links
Helpful Links
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimated)
Study Record Updates
Last Update Posted (Estimated)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 15-337
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Cancer
-
University of Michigan Rogel Cancer CenterRecruitingCancer Liver | Cancer Brain | Cancer Head &Neck | Cancer PelvisUnited States
-
Cellworks Group Inc.RecruitingCancer | Relapsed Cancer | Refractory CancerUnited States
-
UNC Lineberger Comprehensive Cancer CenterHyundai Hope On WheelsRecruitingCancer | Pediatric Cancer | Survivorship | Cancer MetastaticUnited States
-
Vanderbilt-Ingram Cancer CenterNational Institutes of Health (NIH)Active, not recruitingAdvanced Cancer | Relapsed Cancer | Refractory CancerUnited States
-
City of Hope Medical CenterNational Cancer Institute (NCI)CompletedStage III Pancreatic Cancer | Stage IIA Pancreatic Cancer | Stage IIB Pancreatic Cancer | Stage IV Gastric Cancer | Stage IVA Colorectal Cancer | Stage IVA Pancreatic Cancer | Stage IVB Colorectal Cancer | Stage IVB Pancreatic Cancer | Stage IIIA Gastric Cancer | Stage IIIB Gastric Cancer | Stage IIIC Gastric... and other conditionsUnited States
-
MiRXES Pte LtdRecruitingBreast Cancer | Gastric Cancer | Colorectal Cancer | Pancreatic Cancer | Esophageal Cancer | Ovarian Cancer | Prostate Cancer | Thoracic Cancer | Liver CancerSingapore
-
Sidney Kimmel Cancer Center at Thomas Jefferson...CompletedStage I Breast Cancer | Stage I Uterine Corpus Cancer | Stage II Uterine Corpus Cancer | Stage III Uterine Corpus Cancer | Stage II Breast Cancer | Stage IIIA Breast Cancer | Stage IIIB Breast Cancer | Stage IA Breast Cancer | Stage IB Breast Cancer | Stage IIA Breast Cancer | Stage IIB Breast Cancer | Stage... and other conditionsUnited States
-
Massachusetts General HospitalNational Comprehensive Cancer NetworkCompletedGastric Cancer | Pancreatic Cancer | Esophageal Cancer | Rectal Cancer | Colon Cancer | Hepatobiliary CancerUnited States
-
Johns Hopkins UniversityNational Cancer Institute (NCI); National Institute on Minority Health and...Enrolling by invitationCancer | Advanced Cancer | End Stage Cancer | MalignancyUnited States
-
University of California, San FranciscoBristol-Myers Squibb; PfizerTerminatedStage IIIA Rectal Cancer | Stage IIIB Rectal Cancer | Stage IIIC Rectal Cancer | Metastatic Colorectal Adenocarcinoma | Metastatic Colon Adenocarcinoma | Metastatic Rectal Adenocarcinoma | Stage IIIA Colon Cancer | Stage IIIB Colon Cancer | Stage IIIC Colon Cancer | Stage IV Colon Cancer | Stage IV Rectal... and other conditionsUnited States
Clinical Trials on Fecal Microbiota Transplantation (FMT)
-
Memorial Sloan Kettering Cancer CenterActive, not recruitingAllogeneic Hematopoietic Stem CellUnited States
-
Children's Mercy Hospital Kansas CityUniversity of Pittsburgh; Stanford UniversityCompletedUlcerative Colitis (UC) | Inflammatory Bowel Diseases (IBD) | Crohn's Disease (CD)United States
-
Massachusetts General HospitalCompleted
-
The Second Hospital of Nanjing Medical UniversityFuzhou General HospitalUnknown
-
University Hospital of North NorwayOslo University Hospital; Haukeland University Hospital; Sorlandet Hospital HF; Alesund HospitalActive, not recruitingIrritable Bowel SyndromeNorway
-
Susy HotaSinai Health System, Ontario, Canada; University of Toronto, Ontario, Canada; The Toronto Invasive Bacterial Diseases Network, Ontario, Canada and other collaboratorsSuspended
-
Brigham and Women's HospitalIcahn School of Medicine at Mount Sinai; The Miriam Hospital; Indiana UniversityCompletedInflammatory Bowel Diseases | Clostridium Difficile InfectionUnited States
-
Children's Hospital Los AngelesCompleted
-
Fondazione Policlinico Universitario Agostino Gemelli...RecruitingIrritable Bowel SyndromeItaly
-
LifespanUnknownNonalcoholic Fatty Liver DiseaseUnited States