Fecal Microbiota Transplantation for C Diff Infection
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT01905709|
Recruitment Status : Recruiting
First Posted : July 23, 2013
Last Update Posted : July 18, 2019
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.
|Condition or disease||Intervention/treatment||Phase|
|Clostridium Difficile Infection||Biological: Human fecal matter||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||100 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Fecal Microbiota Transplantation for the Treatment of Recurrent or Refractory Clostridium Difficile Infection (CDI)|
|Study Start Date :||July 2013|
|Estimated Primary Completion Date :||July 2020|
|Estimated Study Completion Date :||December 2020|
Experimental: All patients
150-500 ml of human fecal matter
Biological: Human fecal matter
Other Name: human stool
- CDI recurrence [ Time Frame: 8 weeks ]Number of patients who did/did not experience relapse in the 8 weeks post FMT
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01905709
|Contact: Marc Fiorillo, MDfirstname.lastname@example.org|
|Contact: Rosabel Cascinaemail@example.com|
|United States, New Jersey|
|Englewood Hospital and Medical Center||Recruiting|
|Englewood, New Jersey, United States, 07631|
|Contact: Marc Fiorillo, MD 201-945-6564 firstname.lastname@example.org|
|Contact: Rosabel Cascina email@example.com|
|Principal Investigator: Marc Fiorillo, MD|
|Sub-Investigator: Mtichell Spinnell, MD|
|Sub-Investigator: Mark Sapienza, MD|
|Sub-Investigator: Sandarsh Kancherla, MD|
|Sub-Investigator: Irina Kaplounov, MD|
|Sub-Investigator: Michael Meininger, MD|
|Principal Investigator:||Marc Fiorillo, MD||Englewood Hospital and Medical Center|