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

Clostridium Difficile Infection Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01704937
• Other study ID #: 2012-P-001657
• Status: Completed
• Phase: Phase 1
• First received: October 4, 2012
• Last updated: June 18, 2014
• Start date: November 2012
• Est. completion date: May 2014

Study information

• Verified date: June 2014
• Source: Massachusetts General Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: May 2014
• Est. primary completion date: May 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 7 Years to 90 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Clostridium Difficile Infection
• Infection

Intervention

Drug:
• 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

Locations

Country	Name	City	State
United States	Massachusetts General Hospital	Boston	Massachusetts

Sponsors (1)

Lead Sponsor	Collaborator
Massachusetts General Hospital

Country where clinical trial is conducted

United States, 

References & Publications (1)

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, con — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Safety	Safety is assessed by clinical symptoms, exam, signs (GI and systemic)	up to 6 mo post FMT	Yes
Secondary	Efficacy	Efficacy is defined as resolution of C. Difficile signs and symptoms off antibiotics for C. difficile	3 months	No