Fecal Microbiota Transplantation for C Diff Infection
| Status: | Recruiting |
|---|---|
| Conditions: | Infectious Disease |
| Therapuetic Areas: | Immunology / Infectious Diseases |
| Healthy: | No |
| Age Range: | 18 - Any |
| Updated: | 6/16/2018 |
| Start Date: | July 2013 |
| End Date: | December 2019 |
| Contact: | Marc Fiorillo, MD |
| Email: | fiorillomd@gmail.com |
| Phone: | 201-945-6564 |
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.
(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.
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.
We found this trial at
1
site
350 Engle St
Englewood, New Jersey 07631
Englewood, New Jersey 07631
(201) 894-3000
Principal Investigator: Marc Fiorillo, MD
Phone: 201-945-6564
Englewood Hospital and Medical Center Englewood Hospital was incorporated in 1888 as a non-profit, non-sectarian...
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