Fecal Microbiota Transplantation for C Diff Infection

• ClinicalTrials.gov Identifier: NCT01905709
• Recruitment Status: Recruiting
• First Posted: July 23, 2013
• Last Update Posted: July 18, 2019
• Sponsor: Englewood Hospital and Medical Center
• Information provided by (Responsible Party): Englewood Hospital and Medical Center

Study Description

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 Design

• Study Type: Interventional (Clinical Trial)
• Estimated Enrollment: 100 participants
• Allocation: N/A
• 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 2020
• Estimated Study Completion Date: December 2020

Arms and Interventions

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

Outcome Measures

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

Eligibility Criteria

• Ages Eligible for Study: 18 Years and older (Adult, Older Adult)
• 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.

Contacts and Locations

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

More Information

Additional Information:

Related Info 

• Responsible Party: Englewood Hospital and Medical Center
• ClinicalTrials.gov Identifier: NCT01905709
• Other Study ID Numbers: E-13-507
• First Posted: July 23, 2013
• Last Update Posted: July 18, 2019
• Last Verified: July 2019

Keywords provided by Englewood Hospital and Medical Center:

C diff; CDI; clostridium difficile associated diarrhea

Additional relevant MeSH terms:

Infection; Communicable Diseases; Clostridium Infections; Gram-Positive Bacterial Infections; Bacterial Infections