Fecal Microbiota Transplantation for C Diff Infection

Part of paid clinical trials in Englewood, New Jersey.

Sponsor
Englewood Hospital and Medical Center
Study ID
NCT01905709
Status
Recruiting
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Conditions

  • Clostridium Difficile Infection

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Human fecal matter — BIOLOGICAL

Study Details

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.

Key Dates

Start date
Jul 31, 2013
Status verified
Apr 2025
Primary completion
Jul 31, 2026
Completion
Dec 31, 2026

Study Design

Enrollment
100 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: All patients
    150-500 ml of human fecal matter

Primary Outcome Measure

CDI recurrence [ Time Frame: 8 weeks ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Englewood Hospital and Medical CenterEnglewoodNew Jersey07631
Marc Fiorillo, MD
[email protected]
201-945-6564
Dara Herman
[email protected]
Marc Fiorillo, MD (PRINCIPAL_INVESTIGATOR)
Mtichell Spinnell, MD (SUB_INVESTIGATOR)
Mark Sapienza, MD (SUB_INVESTIGATOR)
Sandarsh Kancherla, MD (SUB_INVESTIGATOR)
Irina Kaplounov, MD (SUB_INVESTIGATOR)
Michael Meininger, MD (SUB_INVESTIGATOR)

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