Fecal Microbiota Transplant (FMT) for Relapsing C. Difficile Infection in Adults and Children Using a Frozen Inoculum

Phase 1

Completed

• Conditions: Clostridium Difficile Infection
• Interventions: Drug: Fecal Microbiota Transplant (FMT)

• Registration Number: NCT01704937
• 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 a frozen inoculum administered by nasogastric tube vs administered by colonoscope.

Subjects with recurrent/relapsing C. difficile infection (10 per group) will receive FMT via either:

* colonoscopy

* NGT

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: 2012-10-04
• Study First Submitted QC: 2012-10-11
• Study First Posted: 2012-10-12
• Study Start: 2012-11
• Primary Completion: 2014-05
• Study Completion: 2014-05
• Status Verified: 2014-06
• Last Update Submitted: 2014-06-18
• Last Update Posted: 2014-06-20

Recruitment & Eligibility

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

Inclusion Criteria

• Patients with recurrent or relapsing CDI defined as EITHER(13):

  • At least three episodes of mild-to-moderate CDI and failure of a 6-8 week taper with vancomycin with or without an alternative antibiotic (e.g. rifaximin, nitazoxanide).
  • At least two episodes of severe CDI resulting in hospitalization and associated with significant morbidity.

• Willingness to accept risk of unrelated donor stool

• Willingness to be randomized to NGT vs. colonoscopic delivery.

• Able to consent for self, or parental assent/child assent as age appropriate.

Exclusion Criteria

• Anatomic contraindication to NGT
• Delayed gastric emptying syndrome
• Known chronic aspiration
• Contraindication to colonoscopy (ASA 4 or more)
• High risk of bacterial translocation (Immunosuppression, cirrhosis etc)
• Pregnant or breastfeeding women
• Acute unrelated infection or comorbid illness exaccerbation

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Colonoscopy	Fecal Microbiota Transplant (FMT)	Fecal microbiota transplant ("stool transplant") from healthy, unrelated donor via colonoscopy
Nasogastric Tube (NGT)	Fecal Microbiota Transplant (FMT)	Fecal microbiota transplant ("stool transplant") from healthy, unrelated donor via NGT

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
Efficacy	3 months	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