Fecal Microbiota Transplant for Relapsing Clostridium Difficile Infection in Adults and Children Using a Frozen Encapsulated Inoculum
| Status: | Completed |
|---|---|
| Conditions: | Infectious Disease |
| Therapuetic Areas: | Immunology / Infectious Diseases |
| Healthy: | No |
| Age Range: | 7 - 90 |
| Updated: | 11/8/2014 |
| Start Date: | August 2013 |
| End Date: | September 2014 |
| Contact: | Elizabeth Hohmann, MD |
| Email: | ehohmann@partners.org |
| Phone: | 617-724-7532 |
Fecal Microbiota Transplant (FMT) for Relapsing Clostridium Difficile Infection in Adults and Children Using a Frozen Encapsulated Inoculum
Fecal microbiota transplantation (FMT) is the reconstitution of normal flora by a "stool
transplant" from a healthy individual to a C. difficile-infected recipient, and has long
been a successful approach to recurrent/refractory C. difficile. The purpose of this project
is to generate a frozen FMT inoculum from well-screened healthy volunteer donors which can
be used repeatedly, particularly in those who do not have a healthy intimate partner or
other related donor. Delivery of FMT has been performed colonoscopically, by fecal retention
enema, or by the nasogastric route. This study will evaluate the safety and secondarily the
efficacy of an inoculum administered by frozen orally-administered capsules.
Subjects with recurrent/relapsing C. difficile infection will receive FMT via oral capsules
The primary endpoint is assessment of safety as measured by clinical events (GI, procedural,
systemic). Efficacy will be defined as a resolution of diarrhea off antibiotics for C.
difficile, in the absence of a need for OTHER systemic antibiotics, i.e. resumption of a
normal bowel status for the individual. Secondary efficacy endpoints include weight,
subjective well-being and relative clinical improvement per standardized questionnaire, and
subject qualitative assessment of, and satisfaction with, the transplant procedures.
Subjects will be monitored for clinical safety by history and standard exams and the
follow-up questionnaire as well as followed closely by phone and in person.
transplant" from a healthy individual to a C. difficile-infected recipient, and has long
been a successful approach to recurrent/refractory C. difficile. The purpose of this project
is to generate a frozen FMT inoculum from well-screened healthy volunteer donors which can
be used repeatedly, particularly in those who do not have a healthy intimate partner or
other related donor. Delivery of FMT has been performed colonoscopically, by fecal retention
enema, or by the nasogastric route. This study will evaluate the safety and secondarily the
efficacy of an inoculum administered by frozen orally-administered capsules.
Subjects with recurrent/relapsing C. difficile infection will receive FMT via oral capsules
The primary endpoint is assessment of safety as measured by clinical events (GI, procedural,
systemic). Efficacy will be defined as a resolution of diarrhea off antibiotics for C.
difficile, in the absence of a need for OTHER systemic antibiotics, i.e. resumption of a
normal bowel status for the individual. Secondary efficacy endpoints include weight,
subjective well-being and relative clinical improvement per standardized questionnaire, and
subject qualitative assessment of, and satisfaction with, the transplant procedures.
Subjects will be monitored for clinical safety by history and standard exams and the
follow-up questionnaire as well as followed closely by phone and in person.
Inclusion criteria
- Patients with refractory, recurrent or relapsing C. difficile infection (CDI) defined
as EITHER:
- At least three episodes of mild-to-moderate CDI
- At least two episodes of severe CDI resulting in hospitalization and associated
with significant morbidity
- One protracted episode of CDI, defined as at least 3 weeks of ongoing Grade 3
severe symptoms of CDI despite standard antimicrobial therapy for CDI
- We expect that most, but not all, subjects will have tried and failed a taper of
vancomycin.
- Willingness to accept risk of unrelated donor stool
- Age 7 and above. Seven is chosen as a lower limit based upon the legal age of assent.
Based on the literature, most children aged 7 and above can be taught to swallow even
large capsules through simple coaching techniques
- Able to consent for self, or parental assent/child assent as age appropriate
Exclusion criteria
- Delayed gastric emptying syndrome
- Known chronic aspiration
- Swallowing dysfunction or oral-motor dyscoordination.
- Inability or unwillingness to swallow multiple large capsules
- Pregnant women
- Patients with an acute illness unrelated to CDI or an acute exacerbation of
underlying comorbid condition
- Patients with comorbidities associated with increased risk of serious infection
following bacterial translocation, including but not limited to:
- subjects on major immunosuppressive agents including high dose corticosteroids,
calcineurin inhibitors, mTOR inhibitors, lymphocyte depleting biologic agents,
anti-TNF agents, and others; chemotherapeutic anti-neoplastic agents*
- Patients with decompensated liver cirrhosis, advanced HIV/AIDS, recent bone
marrow transplant, hypoglobulinemia or other cause of severe immunodeficiency*
- Patients with a history of significant allergy to foods not excluded from the donor
diet
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