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

Primary Purpose

Clostridium Difficile Infection

Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
Fecal Microbiota Transplant
Sponsored by
Massachusetts General Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Clostridium Difficile Infection focused on measuring Fecal Microbiota Transplant, Clostridium difficile, Diarrhea

Eligibility Criteria

7 Years - 90 Years (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Massachusetts General Hospital

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Capsule

Arm Description

Fecal microbiota transplant ("stool transplant") from healthy, unrelated donor via frozen capsule

Outcomes

Primary Outcome Measures

Safety
Safety is assessed by clinical symptoms, exam, signs (GI and systemic)

Secondary Outcome Measures

Efficacy
Efficacy is defined as resolution of C. Difficile signs and symptoms off antibiotics for C. difficile

Full Information

First Posted
July 31, 2013
Last Updated
July 15, 2016
Sponsor
Massachusetts General Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT01914731
Brief Title
Fecal Microbiota Transplant for Relapsing Clostridium Difficile Infection in Adults and Children Using a Frozen Encapsulated Inoculum
Official Title
Fecal Microbiota Transplant (FMT) for Relapsing Clostridium Difficile Infection in Adults and Children Using a Frozen Encapsulated Inoculum
Study Type
Interventional

2. Study Status

Record Verification Date
July 2016
Overall Recruitment Status
Completed
Study Start Date
August 2013 (undefined)
Primary Completion Date
October 2014 (Actual)
Study Completion Date
October 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Massachusetts General Hospital

4. Oversight

Data Monitoring Committee
No

5. Study Description

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 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Clostridium Difficile Infection
Keywords
Fecal Microbiota Transplant, Clostridium difficile, Diarrhea

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
20 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Capsule
Arm Type
Experimental
Arm Description
Fecal microbiota transplant ("stool transplant") from healthy, unrelated donor via frozen capsule
Intervention Type
Drug
Intervention Name(s)
Fecal Microbiota Transplant
Other Intervention Name(s)
Poop transplant, Fecal bacteriotherapy
Intervention Description
Reconstitution of normal flora by a "stool transplant" from a healthy individual to a C. difficile - infected recipient via frozen capsule
Primary Outcome Measure Information:
Title
Safety
Description
Safety is assessed by clinical symptoms, exam, signs (GI and systemic)
Time Frame
Up to 6 months post-FMT
Secondary Outcome Measure Information:
Title
Efficacy
Description
Efficacy is defined as resolution of C. Difficile signs and symptoms off antibiotics for C. difficile
Time Frame
Up to 2 months post-FMT

10. Eligibility

Sex
All
Minimum Age & Unit of Time
7 Years
Maximum Age & Unit of Time
90 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Elizabeth Hohmann, MD
Organizational Affiliation
Massachusetts General Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Massachusetts General Hospital
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02114
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
25322359
Citation
Youngster I, Russell GH, Pindar C, Ziv-Baran T, Sauk J, Hohmann EL. Oral, capsulized, frozen fecal microbiota transplantation for relapsing Clostridium difficile infection. JAMA. 2014 Nov 5;312(17):1772-8. doi: 10.1001/jama.2014.13875. Erratum In: JAMA. 2015 Feb 17;313(7):729.
Results Reference
background
Links:
URL
http://www.ncbi.nlm.nih.gov/pubmed?term=JAMA%5BJour%5D+AND+hohmann%5Bauthor%5D&cmd=detailssearch
Description
JAMA paper

Learn more about this trial

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

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