Clinical trial NCT01905709: Fecal Microbiota Transplantation for C Diff Infection
Official title: Fecal Microbiota Transplantation for the Treatment of Recurrent or Refractory Clostridium Difficile Infection (CDI)
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Clostridium Difficile Infection
Keywords: C diff
CDI
clostridium difficile associated diarrhea
Lead sponsor: Englewood Hospital and Medical Center
Sponsor class: OTHER
First posted: 2013-07-23
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.


Eligibility 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.

Primary outcomes:
measure: CDI recurrence
timeFrame: 8 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Englewood
country: United States
facility: Englewood Hospital and Medical Center
state: New Jersey
Study officials:
affiliation: Englewood Hospital and Medical Center
name: Marc Fiorillo, MD
role: PRINCIPAL_INVESTIGATOR
References: