Fecal Microbiota Transplantation for C. diff Infection
Trial Summary
Do I need to stop my current medications for this trial?
The trial information does not specify if you need to stop taking your current medications. However, since it involves patients who have failed standard therapy with certain antibiotics, you might need to discuss your current medications with the trial team.
What data supports the effectiveness of the treatment Fecal Microbiota Transplantation for C. diff Infection?
Research shows that Fecal Microbiota Transplantation (FMT) is highly effective for treating recurrent C. difficile infections, with cure rates over 90% and fewer recurrences compared to standard antibiotic treatments. It is also promising for severe cases, reducing the need for surgery and lowering death rates.12345
Is fecal microbiota transplantation (FMT) safe for humans?
How is fecal microbiota transplantation different from other treatments for C. diff infection?
Fecal microbiota transplantation (FMT) is unique because it involves transplanting stool from a healthy donor to restore the natural balance of bacteria in the gut, which is different from traditional antibiotic treatments. FMT has shown high cure rates and lower recurrence rates for recurrent C. diff infections compared to antibiotics, and it can be particularly effective for severe cases where other treatments have failed.1351011
What is the purpose of this trial?
The purpose of this study is to see if stool transplant performed by colonoscopy is effective at treating recurrent Clostridium difficile (C. diff) infection of the colon. During the procedure a stool sample is taken from a healthy donor (usually family member or close friend) and transplanted directly into the colon of the patient with C. diff infection. The goal of this experimental procedure (called fecal microbiota transplantation) is to replenish the good bacteria in the colon that can help prevent C. diff infection from coming back after treatment.
Research Team
Krunal Patel
Principal Investigator
UMass Medical School
Eligibility Criteria
This trial is for people who've had at least two recurrences of C. diff infection, with symptoms coming back within 2-8 weeks after treatment. It's also for those whose severe C. diff led to hospitalization and didn't improve with standard antibiotics. Participants must be over 16 and not at risk of colon perforation.Inclusion Criteria
Exclusion Criteria
Timeline
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive fecal microbiota transplantation via colonoscopy to treat recurrent Clostridium difficile infection
Follow-up
Participants are monitored for safety and effectiveness after fecal microbiota transplantation
Treatment Details
Interventions
- Fecal Microbiota Transplantation
Fecal Microbiota Transplantation is already approved in United States, European Union, Canada for the following indications:
- Graft-versus-host disease (GVHD)
- Clostridioides difficile infection (CDI)
- Graft-versus-host disease (GVHD)
- Clostridioides difficile infection (CDI)
- Other gastrointestinal disorders
- Graft-versus-host disease (GVHD)
- Clostridioides difficile infection (CDI)
Find a Clinic Near You
Who Is Running the Clinical Trial?
Krunal Patel
Lead Sponsor