Skip to main content
OpenTrials
Completed

NCT Number: NCT02770326

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

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

C. Difficile Infection Cancer Neoplasms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Memorial Sloan Kettering Cancer Center

New York, 10065, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Fecal Microbiota Transplantation (FMT)

Biological

Primary outcomes

  1. Number of Participants Evaluated for Infection During Treatment Intervention

    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.

Sponsors and collaborators

Lead sponsor

Memorial Sloan Kettering Cancer Center

Other

Registry information

Official study title

Safety of Fecal Microbiota Transplantation (FMT) for Recurrent or Refractory C. Difficile Infection in Patients With Solid Tumors

Important dates

Study start
2016
Primary completion
2024
Study completion
2024
First posted
May 12, 2016
Registry last updated
Apr 8, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.