Fecal Transplant for C-diff Infection
(FMT Trial)
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial explores a new method to treat C-diff infections, which often cause belly pain and diarrhea and are difficult to manage with standard medicine. Researchers believe that introducing "good" bacteria to the colon through a fecal transplant (also known as Fecal Microbiota Transplantation) can combat the "bad" bacteria causing the infection. The trial aims to determine the best way to perform this transplant at Nationwide Children's Hospital. Individuals who have experienced at least three C-diff infections, have ongoing diarrhea, and require a colonoscopy might be suitable candidates for this trial. As a Phase 1 trial, the research focuses on understanding how the treatment works in people, offering participants a chance to be among the first to receive this innovative treatment.
Do I need to stop my current medications for the trial?
The trial does not specify if you need to stop your current medications, but you cannot participate if you are on high-dose immunosuppressive medications. It's best to discuss your specific medications with the trial team.
Is there any evidence suggesting that this treatment is likely to be safe for humans?
Research has shown that fecal microbiota transplantation (FMT) is generally safe for treating Clostridioides difficile (C-diff) infections and is well-tolerated, even by those with weakened immune systems.
One study found no major differences in side effects between FMT and a placebo, which contains no active ingredients. Another review highlights FMT as a well-known and effective treatment for recurring C-diff infections.
Overall, FMT has a good safety record in humans and may help restore the balance of gut bacteria to combat C-diff.12345Why do researchers think this study treatment might be promising?
Fecal Microbiota Transplantation (FMT) is unique because it introduces beneficial bacteria directly into the gut to restore a healthy balance, unlike traditional antibiotics that often kill both harmful and helpful bacteria in cases of C-diff infection. This method uses a fecal suspension administered by colonoscopy or enema to target the infection at its source. Researchers are excited about FMT because it has the potential to rapidly reset the gut microbiome, providing quicker relief and reducing recurrence rates compared to standard antibiotic treatments.
What evidence suggests that fecal microbiota transplantation might be an effective treatment for C-diff infection?
Research has shown that fecal microbiota transplantation (FMT), which participants in this trial will receive, effectively treats recurrent C-diff infections. Studies have found that FMT significantly reduces the risk of this infection returning, which often causes severe diarrhea and stomach pain. The treatment introduces "good" bacteria into the colon to combat the "bad" bacteria responsible for the infection. Real-world evidence supports FMT as a proven and effective treatment for C-diff, with many studies reporting high success rates. Hospitals have successfully used this method to help patients who have not responded well to other treatments.23678
Who Is on the Research Team?
Jonathan M. Gisser, M.D.
Principal Investigator
Nationwide Children's Hospital
Are You a Good Fit for This Trial?
This trial is for children and young adults aged 2 to less than 21 years with recurrent C-diff infection, who are undergoing a colonoscopy. Participants must have had at least three episodes of this infection. Healthy first-degree relatives over 18 can be donors, but they shouldn't have taken antibiotics recently or have any listed health issues.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Pre-transplant Evaluation
Evaluation of lab results from the participant and donor to ensure safety for fecal transplant
Fecal Transplant
Participants receive fecal microbiota transplantation via colonoscopy or enema
Follow-up
Participants are monitored for safety and effectiveness after treatment through phone calls
What Are the Treatments Tested in This Trial?
Interventions
- Fecal Microbiota Transplantation
Trial Overview
The study tests fecal microbiota transplantation (FMT) in pediatric patients with recurrent C-diff infections. FMT involves transferring stool from a healthy donor into the patient's colon to balance the bacteria and combat the infection.
How Is the Trial Designed?
1
Treatment groups
Experimental Treatment
250 ml of a fecal suspension diluted in saline given by colonoscopy or enema.
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?
Jonathan Gisser
Lead Sponsor
Citations
Fecal Microbiota Transplantation Is Highly Effective in Real ...
Fecal microbiota transplantation is highly effective in real-world practice: Initial results from the FMT National Registry.
Real-world Effectiveness of Fecal Microbiota ...
Clostridioides difficile infection (CDI) is associated with high mortality. Fecal microbiota transplantation (FMT) is an established treatment for recurrent CDI ...
A Randomized Controlled Trial of Efficacy and Safety of Fecal ...
, et al. Effect of fecal microbiota transplantation on recurrence in multiply recurrent Clostridium difficile infection: a randomized trial . Ann Intern Med.
Fecal microbiota transplantation: Current evidence and ...
Fecal microbiota transplantation (FMT), a well-established procedure, is recognized for effectively treating recurrent Clostridioides difficile infection.
Clinical management of Clostridioides difficile infection ...
Faecal microbiota transplantation (FMT) is a well-established treatment with high cumulative effectiveness for Clostridioides difficile ...
A Randomized Controlled Trial of Efficacy and Safety ...
Conclusions: FMT therapy versus placebo did not reduce CDI recurrence or death at 56 days. There were no meaningful differences in adverse ...
AGA Clinical Practice Guideline on Fecal Microbiota ...
∙ Grinspan, A. Fecal microbiota transplant for Clostridioides difficile infection is safe and efficacious in an immunocompromised cohort. Dig Dis Sci. 2022 ...
8.
uptodate.com
uptodate.com/contents/fecal-microbiota-transplantation-for-treatment-of-clostridioides-difficile-infectionFecal microbiota transplantation for treatment of Clostridioides ...
Fecal microbiota transplantation (FMT) refers to administration of stool bacteria into the intestinal tract of a patient with Clostridioides ...
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