Fecal Microbiota Transplant for Relapsing Clostridium Difficile Infection in Adults and Children Using a Frozen Encapsulated Inoculum

This study is currently recruiting participants. (see Contacts and Locations)
Verified August 2013 by Massachusetts General Hospital
Sponsor:
Information provided by (Responsible Party):
Elizabeth L. Hohmann, MD, Massachusetts General Hospital
ClinicalTrials.gov Identifier:
NCT01914731
First received: July 31, 2013
Last updated: August 6, 2013
Last verified: August 2013
  Purpose

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.


Condition Intervention Phase
Clostridium Difficile Infection
Drug: Fecal Microbiota Transplant
Phase 1

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Fecal Microbiota Transplant (FMT) for Relapsing Clostridium Difficile Infection in Adults and Children Using a Frozen Encapsulated Inoculum

Resource links provided by NLM:


Further study details as provided by Massachusetts General Hospital:

Primary Outcome Measures:
  • Safety [ Time Frame: Up to 6 months post-FMT ] [ Designated as safety issue: Yes ]
    Safety is assessed by clinical symptoms, exam, signs (GI and systemic)


Secondary Outcome Measures:
  • Efficacy [ Time Frame: Up to 2 months post-FMT ] [ Designated as safety issue: No ]
    Efficacy is defined as resolution of C. Difficile signs and symptoms off antibiotics for C. difficile


Estimated Enrollment: 20
Study Start Date: August 2013
Estimated Study Completion Date: September 2014
Estimated Primary Completion Date: September 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Capsule
Fecal microbiota transplant ("stool transplant") from healthy, unrelated donor via frozen capsule
Drug: Fecal Microbiota Transplant
Reconstitution of normal flora by a "stool transplant" from a healthy individual to a C. difficile - infected recipient via frozen capsule
Other Names:
  • Poop transplant
  • Fecal bacteriotherapy

  Eligibility

Ages Eligible for Study:   7 Years to 90 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01914731

Contacts
Contact: Elizabeth Hohmann, MD 617-724-7532 ehohmann@partners.org
Contact: Christina Pindar, BA 617-724-8625 cpindar@partners.org

Locations
United States, Massachusetts
Massachusetts General Hospital Recruiting
Boston, Massachusetts, United States, 02114
Contact: Elizabeth Hohmann, MD    617-724-8625    ehohmann@partners.org   
Contact: Christina Pindar, BA    617-724-8625    cpindar@partners.org   
Principal Investigator: Elizabeth Hohmann, MD         
Sub-Investigator: Ilan Youngster, MD         
Sponsors and Collaborators
Massachusetts General Hospital
Investigators
Principal Investigator: Elizabeth Hohmann, MD Massachusetts General Hospital
  More Information

No publications provided

Responsible Party: Elizabeth L. Hohmann, MD, Principal Investigator, Massachusetts General Hospital
ClinicalTrials.gov Identifier: NCT01914731     History of Changes
Other Study ID Numbers: 2013-P-001355
Study First Received: July 31, 2013
Last Updated: August 6, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by Massachusetts General Hospital:
Fecal Microbiota Transplant
Clostridium difficile
Diarrhea

ClinicalTrials.gov processed this record on September 14, 2014