Fecal Microbiota Transplantation for C Diff Infection

Fecal Microbiota Transplantation for the Treatment of Recurrent or Refractory Clostridium Difficile Infection (CDI)

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.

Study Overview

• Status: Recruiting
• Conditions: Clostridium Difficile Infection
• Intervention / Treatment: Biological: Human fecal matter

• Study Type: Interventional
• Enrollment (Anticipated): 100
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Marc Fiorillo, MD; Phone Number: 201-945-6564; Email: fiorillomd@gmail.com
• Study Contact Backup: Name: Rosabel Cascina; Email: rosabel.cascina@ehmc.com

Study Locations

• United States
  • New Jersey
    • Englewood, New Jersey, United States, 07631
      • Recruiting
      • Englewood Hospital and Medical Center
      • Contact: Marc Fiorillo, MD; Phone Number: 201-945-6564; Email: fiorillomd@gmail.com
      • Contact: Dara Herman; Email: dara.herman@ehmchealth.org
      • 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

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: All patients; 150-500 ml of human fecal matter	Biological: Human fecal matter; Other Names: human stool

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
CDI recurrence	Number of patients who did/did not experience relapse in the 8 weeks post FMT	8 weeks

Collaborators and Investigators

• Sponsor: Englewood Hospital and Medical Center
• Investigators: Principal Investigator: Marc Fiorillo, MD, Englewood Hospital and Medical Center

Publications and helpful links

Helpful Links

• Related Info

Study record dates

Study Major Dates

• Study Start: July 1, 2013
• Primary Completion (Anticipated): July 1, 2023
• Study Completion (Anticipated): December 1, 2023

Study Registration Dates

• First Submitted: July 19, 2013
• First Submitted That Met QC Criteria: July 22, 2013
• First Posted (Estimate): July 23, 2013

Study Record Updates

• Last Update Posted (Actual): August 18, 2021
• Last Update Submitted That Met QC Criteria: August 16, 2021
• Last Verified: August 1, 2021

More Information

Terms related to this study

• Keywords: CDI; clostridium difficile associated diarrhea; C diff
• Additional Relevant MeSH Terms: Pathologic Processes; Disease Attributes; Bacterial Infections; Bacterial Infections and Mycoses; Gram-Positive Bacterial Infections; Infections; Communicable Diseases; Clostridium Infections
• Other Study ID Numbers: E-13-507