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

Sponsor
Memorial Sloan Kettering Cancer Center (Other)
Overall Status
Active, not recruiting
CT.gov ID
NCT02770326
Collaborator
(none)
10
Enrollment
1
Location
1
Arm
83.7
Anticipated Duration (Months)
0.1
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Biological: Fecal Microbiota Transplantation (FMT)
 N/A

Study Design

Study Type:
Interventional
Actual Enrollment :
10 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
Safety of Fecal Microbiota Transplantation (FMT) for Recurrent or Refractory C. Difficile Infection in Patients With Solid Tumors
Actual Study Start Date :
May 10, 2016
Anticipated Primary Completion Date :
May 1, 2023
Anticipated Study Completion Date :
May 1, 2023

Arms and Interventions

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.

Biological: Fecal Microbiota Transplantation (FMT)

Outcome Measures

Primary Outcome Measures

  1. Evaluate safety based the number of infections [2 weeks after the FMT]

    Safety will be assessed by monitoring two types of infections that occur within 2 weeks of the FMT procedure.

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts 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

    1. 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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Memorial Sloan Kettering Cancer Center New York New York United States 10065

Sponsors and Collaborators

  • Memorial Sloan Kettering Cancer Center

Investigators

  • Principal Investigator: Robin B. Mendelsohn, MD, Memorial Sloan Kettering Cancer Center

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

Publications

None provided.
Responsible Party:
Memorial Sloan Kettering Cancer Center
ClinicalTrials.gov Identifier:
NCT02770326
Other Study ID Numbers:
  • 15-337
First Posted:
May 12, 2016
Last Update Posted:
Jun 13, 2022
Last Verified:
Jun 1, 2022
Keywords provided by Memorial Sloan Kettering Cancer Center
Safety of Stool Transplant
Fecal Microbiota Transplantation (FMT)
15-337
Additional relevant MeSH terms:
Infections
Communicable Diseases

Study Results

No Results Posted as of Jun 13, 2022