Fecal Transplant for C Diff Infection
What You Need to Know Before You Apply
What is the purpose of this trial?
The objective of this study is to provide treatment with Fecal Microbiota Transplantation (FMT) to patients with recurrent or refractory Clostridium difficile infection (CDI). It has been shown that good bacteria (like that found in the stool from a healthy donor) attack Clostridium difficile in multiple ways: they make substances that kill Clostridium difficile - and they attach to the surface of the colon lining, which prevents the Clostridium difficile toxin (poison) from attaching.FMT involves infusing a mixture of saline and stool from a healthy donor into the bowel of the patient with CDI during a colonoscopy.The method used to deliver the FMT will depend on individual characteristics of the subject and is at the discretion of the treating physician. FMT may be administered by the following methods.* Colonoscopy: This method allows full endoscopic examination of the colon and exclusion of comorbid conditions (such as IBD, malignancy or microscopic colitis) which may have an impact on subject's treatment or response to therapy.* Sigmoidoscopy: This method still allows infusion of the stool into a more proximal segment of the colon than an enema, but may not require sedation. This method may be beneficial in subjects who are elderly or multiparous and who may have difficulty retaining the material when given as enema. Sigmoidoscopic administration eliminates the additional risks associated with colonoscopy in subjects who may not have a clear indication for colonoscopy.* Retention enema: This method may be preferable in younger subjects who have already had recent endoscopic evaluation, in subjects who prefer not to undergo endoscopy or in subjects with significant co morbidities and may not tolerate endoscopy.The physician will administer 300-500 mL of the fecal suspension in aliquots of 60 mL, through the colonoscope or sigmoidoscope or 150 mL via retention enema. In cases of colonoscopic delivery, the material will be delivered to the most proximal point of insertion.The subject is encouraged to retain stool for as long as possible.
Will I have to stop taking my current medications?
The trial protocol does not specify whether you need to stop taking your current medications. However, since the trial involves treating recurrent or severe C. difficile infections, it's possible that you may need to continue certain antibiotics as part of your treatment plan.
Is fecal microbiota transplantation (FMT) safe for treating C. difficile infections?
FMT is generally considered safe and well-tolerated, even in high-risk patients, with most short-term risks being mild and related to delivery methods. Long-term side effects are not well established, but no serious harm has been found to date. Careful donor screening is important to minimize risks, and ongoing research aims to improve safety and tolerability.12345
How is fecal transplant treatment different from other treatments for C. diff infection?
Fecal transplant treatment is unique because it uses stool from a healthy donor to restore the natural balance of bacteria in the patient's gut, unlike traditional treatments that rely on antibiotics to kill the bacteria. This approach is particularly effective for patients with recurrent infections where antibiotics have failed.678910
What data supports the effectiveness of the treatment for C. difficile infection?
Who Is on the Research Team?
Marc Fiorillo, MD
Principal Investigator
Englewood Hospital and Medical Center
Are You a Good Fit for This Trial?
This trial is for adults who've had multiple severe Clostridium difficile infections (CDI) that led to hospital stays or didn't respond to standard treatments like vancomycin. Participants must be able to give informed consent and, if they can have children, agree to use birth control for up to 4 weeks after treatment. Pregnant individuals or those unable to follow the study plan cannot join.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive Fecal Microbiota Transplantation (FMT) via colonoscopy, sigmoidoscopy, or retention enema
Follow-up
Participants are monitored for CDI recurrence and safety for 8 weeks post FMT
What Are the Treatments Tested in This Trial?
Interventions
- Human fecal matter
Find a Clinic Near You
Who Is Running the Clinical Trial?
Englewood Hospital and Medical Center
Lead Sponsor