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Fecal Microbiota Transplantation for C Diff Infection

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ClinicalTrials.gov Identifier: NCT01905709
Recruitment Status : Recruiting
First Posted : July 23, 2013
Last Update Posted : February 1, 2018
Sponsor:
Information provided by (Responsible Party):
Englewood Hospital and Medical Center

Brief Summary:

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)
Primary Purpose: Treatment
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 2019
Estimated Study Completion Date : December 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Bowel Movement
U.S. FDA Resources

Arm Intervention/treatment
Experimental: All patients
150-500 ml of human fecal matter
Biological: Human fecal matter
Other Name: human stool



Primary Outcome Measures :
  1. CDI recurrence [ Time Frame: 8 weeks ]
    Number of patients who did/did not experience relapse in the 8 weeks post FMT



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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Subject is at least 18 years old.
  2. Subject has recurrent or relapsing CDI defined as:

    • At least three episodes of mild-to-moderate CDI and failure of a 6-8 week taper with vancomycin with or without an alternative antibiotic (e.g., rifaximin, nitazoxanide, fidaxomicin). OR
    • At least two episodes of severe CDI resulting in hospitalization and associated with significant morbidity. OR
    • Moderate CDI not responding to standard therapy (vancomycin) for at least a week. OR
    • Severe C. difficile infection with toxic megacolon, not responding to standard therapy or the use of IVIg.
  3. Subject is willing and able to provide informed consent.
  4. If a female of childbearing potential, subject has agreed to use an acceptable form of birth control for up to 4 weeks after FMT treatment.

Exclusion Criteria:

  1. Subject is pregnant.
  2. Subject is unable to comply with study requirements.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01905709


Contacts
Contact: Marc Fiorillo, MD 201-945-6564 fiorillomd@gmail.com
Contact: Rosabel Cascina rosabel.cascina@ehmc.com

Locations
United States, New Jersey
Englewood Hospital and Medical Center Recruiting
Englewood, New Jersey, United States, 07631
Contact: Marc Fiorillo, MD    201-945-6564    fiorillomd@gmail.com   
Contact: Rosabel Cascina       rosabel.cascina@ehmc.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         
Sponsors and Collaborators
Englewood Hospital and Medical Center
Investigators
Principal Investigator: Marc Fiorillo, MD Englewood Hospital and Medical Center

Additional Information:
Responsible Party: Englewood Hospital and Medical Center
ClinicalTrials.gov Identifier: NCT01905709     History of Changes
Other Study ID Numbers: E-13-507
First Posted: July 23, 2013    Key Record Dates
Last Update Posted: February 1, 2018
Last Verified: January 2018

Keywords provided by Englewood Hospital and Medical Center:
C diff
CDI
clostridium difficile associated diarrhea

Additional relevant MeSH terms:
Infection
Communicable Diseases