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

NCT01704937 | Completed Phase 1

• 1 other identifier: 2012-P-001657
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

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

Keywords

Fecal Microbiota Transplant; Clostridium difficile; Diarrhea

Outcome Measures

Primary Outcomes (1)

• Safety

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

  up to 6 mo post FMT

Secondary Outcomes (1)

• Efficacy

  3 months

Study Arms (2)

Colonoscopy

EXPERIMENTAL

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

Drug: Fecal Microbiota Transplant (FMT)

Nasogastric Tube (NGT)

EXPERIMENTAL

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

Drug: Fecal Microbiota Transplant (FMT)

Interventions

Fecal Microbiota Transplant (FMT) DRUG

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

Colonoscopy; Nasogastric Tube (NGT)

Eligibility Criteria

• Age: 7 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Massachusetts General Hospital: lead

Study Sites (1)

Massachusetts General Hospital

Boston, Massachusetts, 02114, United States

Location

Related 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, controlled pilot study. Clin Infect Dis. 2014 Jun;58(11):1515-22. doi: 10.1093/cid/ciu135. Epub 2014 Apr 23.

  PMID: 24762631 RESULT

MeSH Terms

Conditions

Clostridium Infections; Diarrhea

Interventions

Fecal Microbiota Transplantation

Condition Hierarchy (Ancestors)

Gram-Positive Bacterial Infections; Bacterial Infections; Bacterial Infections and Mycoses; Infections; Signs and Symptoms, Digestive; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Biological Therapy; Therapeutics

Study Officials

• Elizabeth L Hohmann, MD

  Massachusetts General Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: October 4, 2012
• First Posted: October 12, 2012
• Study Start: November 1, 2012
• Primary Completion: May 1, 2014
• Study Completion: May 1, 2014
• Last Updated: June 20, 2014

Record last verified: 2014-06

Locations

US (1)