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

Phase 1

Completed

• Conditions: Clostridium Difficile Infection
• Interventions: Drug: Fecal Microbiota Transplant

• Registration Number: NCT01914731
• Lead Sponsor: Massachusetts General Hospital

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2013-07-31
• Study Start: 2013-08
• Study First Submitted QC: 2013-08-01
• Study First Posted: 2013-08-02
• Primary Completion: 2014-10
• Study Completion: 2014-10
• Status Verified: 2016-07
• Last Update Submitted: 2016-07-15
• Last Update Posted: 2016-07-19

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 20

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Capsule	Fecal Microbiota Transplant	Fecal microbiota transplant ("stool transplant") from healthy, unrelated donor via frozen capsule

Primary Outcome Measures

Name	Time	Method
Safety	Up to 6 months post-FMT	Safety is assessed by clinical symptoms, exam, signs (GI and systemic)

Secondary Outcome Measures

Name	Time	Method
Efficacy	Up to 2 months post-FMT	Efficacy is defined as resolution of C. Difficile signs and symptoms off antibiotics for C. difficile

Trial Locations

Locations (1)

Massachusetts General Hospital; 🇺🇸 Boston, Massachusetts, United States