Status:
COMPLETED
Fecal Microbiota Transplant for Relapsing Clostridium Difficile Infection in Adults and Children Using a Frozen Encapsulated Inoculum
Lead Sponsor:
Massachusetts General Hospital
Conditions:
Clostridium Difficile Infection
Eligibility:
All Genders
7-90 years
Phase:
PHASE1
Brief Summary
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 appr...
Eligibility Criteria
Inclusion
- 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
Exclusion
Key Trial Info
Start Date :
August 1 2013
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 1 2014
Estimated Enrollment :
20 Patients enrolled
Trial Details
Trial ID
NCT01914731
Start Date
August 1 2013
End Date
October 1 2014
Last Update
July 19 2016
Active Locations (1)
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1
Massachusetts General Hospital
Boston, Massachusetts, United States, 02114