500 Participants Needed

Fecal Microbiota Transplantation for C. diff Infection

AF
Overseen ByAnne Foley
Age: Any Age
Sex: Any
Trial Phase: Academic
Sponsor: Krunal Patel
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)
Approved in 3 JurisdictionsThis treatment is already approved in other countries

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?

FMT is generally considered safe and well-tolerated, even in high-risk patients, with most short-term risks being mild. However, long-term side effects are not well-established, and serious adverse events have been linked to inadequate donor screening for drug-resistant organisms.678910

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

KP

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

I've been hospitalized for a severe C. diff infection that didn't improve with antibiotics.
I have had C. difficile infection recur at least twice after treatment.
I have tried and not responded to standard treatments like metronidazole or vancomycin.

Exclusion Criteria

I am younger than 16 years old.
I am at risk for a tear in my colon due to severe swelling.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive fecal microbiota transplantation via colonoscopy to treat recurrent Clostridium difficile infection

1 day
1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after fecal microbiota transplantation

12 months
Periodic visits (in-person)

Treatment Details

Interventions

  • Fecal Microbiota Transplantation
Trial Overview The study tests fecal microbiota transplantation (FMT) via colonoscopy to treat recurrent C. diff infections by transferring stool from a healthy donor into the patient's colon, aiming to restore beneficial bacteria.
Participant Groups
1Treatment groups
Experimental Treatment
Group I: Fecal Microbiota TransplantationExperimental Treatment1 Intervention
Subjects receive intervention of stool transplanted to the colon via colonoscopy.

Fecal Microbiota Transplantation is already approved in United States, European Union, Canada for the following indications:

πŸ‡ΊπŸ‡Έ
Approved in United States as Fecal Microbiota Transplantation for:
  • Graft-versus-host disease (GVHD)
  • Clostridioides difficile infection (CDI)
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Approved in European Union as Fecal Microbiota Transplantation for:
  • Graft-versus-host disease (GVHD)
  • Clostridioides difficile infection (CDI)
  • Other gastrointestinal disorders
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Approved in Canada as Fecal Microbiota Transplantation for:
  • Graft-versus-host disease (GVHD)
  • Clostridioides difficile infection (CDI)

Find a Clinic Near You

Who Is Running the Clinical Trial?

Krunal Patel

Lead Sponsor

Trials
1
Recruited
500+

Findings from Research

Fecal microbiota transplantation (FMT) has a cure rate of over 90% for recurrent Clostridioides difficile infection (CDI) and is more effective than antibiotics in preventing recurrence.
Emerging evidence suggests that FMT is beneficial for severe and fulminant CDI, potentially reducing mortality and the need for colectomy, and should be considered early in treatment for critically-ill patients.
Fecal Microbiota Transplantation: Redefining Surgical Management of Refractory Clostridium difficile Infection.Cheng, YW., Fischer, M.[2021]
Fecal microbiota transplantation (FMT) significantly reduces the recurrence of Clostridium difficile infection (CDI) in patients, according to a mathematical model based on data from hospitals in the southeastern United States.
While FMT helps prevent recurrent CDI, it does not lower the overall incidence of new cases, indicating that additional strategies are needed to prevent transmission of the infection.
A mathematical model to evaluate the routine use of fecal microbiota transplantation to prevent incident and recurrent Clostridium difficile infection.Lofgren, ET., Moehring, RW., Anderson, DJ., et al.[2022]
In a study of 35 patients with recurrent C. difficile infection, 85.7% experienced resolution of their symptoms within 6-8 weeks after undergoing fecal microbiota transplantation (FMT), indicating its effectiveness as a treatment option.
Among patients with a history of inflammatory bowel disease, 75% reported symptom resolution post-FMT, suggesting that FMT may also be beneficial for this high-risk group.
Fecal microbiota transplantation in recurrent Clostridium difficile infection: A retrospective single-center chart review.Kim, P., Gadani, A., Abdul-Baki, H., et al.[2022]

References

Fecal Microbiota Transplantation: Redefining Surgical Management of Refractory Clostridium difficile Infection. [2021]
A mathematical model to evaluate the routine use of fecal microbiota transplantation to prevent incident and recurrent Clostridium difficile infection. [2022]
Fecal microbiota transplantation in recurrent Clostridium difficile infection: A retrospective single-center chart review. [2022]
A systematic review of economic evaluation in fecal microbiota transplantation. [2021]
A Practical Method for Preparation of Fecal Microbiota Transplantation. [2020]
Fecal Microbiota Transplantation: Is It Safe? [2021]
[Current research progress and thinking of fecal microbiota transplantation for the treatment of gastrointestinal disorders]. [2020]
Stool Banking for Fecal Microbiota Transplantation: Methods and Operations at a Large Stool Bank. [2021]
Fecal Microbiota Transplant in Recurrent Clostridium Difficile Infections: A Systematic Review. [2022]
Donor program for fecal microbiota transplantation: A 3-year experience of a large-volume Italian stool bank. [2021]
11.United Statespubmed.ncbi.nlm.nih.gov
Clinical Application and Potential of Fecal Microbiota Transplantation. [2022]
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