Actively Recruiting
Fecal Microbiota Transplantation for C Diff Infection
Led by Englewood Hospital and Medical Center · Updated on 2025-04-13
100
Participants Needed
1
Research Sites
700 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Fecal Microbiota Transplantation for C Diff Infection
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Subject is at least 18 years old.
- Subject has recurrent or relapsing Clostridium difficile infection defined as either at least three episodes of mild-to-moderate CDI with failure of a 6-8 week vancomycin taper with or without an alternative antibiotic, or at least two episodes of severe CDI causing hospitalization and significant morbidity.
- Subject has moderate CDI not responding to standard vancomycin therapy for at least one week.
- Subject has severe CDI with toxic megacolon not responding to standard therapy or intravenous immunoglobulin use.
- Subject is willing and able to provide informed consent.
- Female subjects of childbearing potential agree to use acceptable birth control for up to 4 weeks after treatment.
You will not qualify if you...
- Subject is pregnant.
- Subject is unable to comply with study requirements.
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 1 location
1
Englewood Hospital and Medical Center
Englewood, New Jersey, United States, 07631
Actively Recruiting
Research Team
M
Marc Fiorillo, MD
CONTACT
R
Rosabel Cascina
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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