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

NCT ID: NCT01704937

Last Updated: 2014-06-20

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 20 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2012-11-30
• Study Completion Date: 2014-05-31

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.

Conditions

Clostridium Difficile Infection

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Colonoscopy

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

Group Type: EXPERIMENTAL

Fecal Microbiota Transplant (FMT)

Intervention Type: DRUG

Reconstitution of normal flora by a "stool transplant" from a healthy individual to a C. difficile - infected recipient via colonoscopy or nasogastric tube

Nasogastric Tube (NGT)

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

Group Type: EXPERIMENTAL

Fecal Microbiota Transplant (FMT)

Intervention Type: DRUG

Reconstitution of normal flora by a "stool transplant" from a healthy individual to a C. difficile - infected recipient via colonoscopy or nasogastric tube

Interventions

Fecal Microbiota Transplant (FMT)

Reconstitution of normal flora by a "stool transplant" from a healthy individual to a C. difficile - infected recipient via colonoscopy or nasogastric tube

Intervention Type: DRUG

Eligibility Criteria

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

• Minimum Eligible Age: 7 Years
• Maximum Eligible Age: 90 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Massachusetts General Hospital

OTHER

Sponsor Role: lead

Responsible Party

Elizabeth L. Hohmann, MD

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Elizabeth L Hohmann, MD

Role: PRINCIPAL_INVESTIGATOR

Massachusetts General Hospital

Locations

Massachusetts General Hospital

Boston, Massachusetts, United States

Countries

United States

References

Youngster I, Sauk J, Pindar C, Wilson RG, Kaplan JL, Smith MB, Alm EJ, Gevers D, Russell GH, Hohmann EL. Fecal microbiota transplant for relapsing Clostridium difficile infection using a frozen inoculum from unrelated donors: a randomized, open-label, controlled pilot study. Clin Infect Dis. 2014 Jun;58(11):1515-22. doi: 10.1093/cid/ciu135. Epub 2014 Apr 23.

Reference Type: RESULT

PMID: 24762631 (View on PubMed)

Other Identifiers

2012-P-001657

Identifier Type: -

Identifier Source: org_study_id