Fecal Transplant for Relapsing C. Difficile Infection

NCT01703494 | Unknown Phase 2 DMC

• 1 other identifier: 1R21DK093839-01A1
• Study Type: interventional
• Target: 53
• Locations: 1 country
• Sites: 2

Brief Summary

There has been an alarming increase in the incidence and severity of Clostridium difficile infection (CDI) in North America over the past decade. Relapsing infection is a common problem in patients treated for CDI, often requiring prolonged and expensive courses of oral vancomycin with limited alternative treatment options. This study will determine if fecal microbiota transplantation, which involves administering fecal flora from a healthy stool donor to a patient with relapsing CDI, is an effective and safe treatment.

Conditions

Clostridium Difficile

Keywords

C. difficile; fecal transplant; stool transplant; fecal flora reconstitution; fecal microbiota transplant; FMT

Outcome Measures

Primary Outcomes (1)

• Clinical Cure

  Resolution of diarrhea (i.e., fewer than three unformed stools for two consecutive days), with maintenance of resolution for the duration of the 8 week follow-up period and no further requirements for anti-infective therapy for C. difficile infection). Subjects who meet this definition will be considered cured regardless of results of follow-up stool testing for C. difficile.

  8 weeks

Secondary Outcomes (1)

• Clinical Failure

  8 weeks

Other Outcomes (1)

• Number of Participants with Adverse Events as a Measure of Safety and Tolerability

  6 months

Study Arms (2)

Fecal Microbiota Transplantation

ACTIVE COMPARATOR

After completing at least a 10 day course of vancomycin for treatment of the most recent acute C. difficile infection, subjects will receive fecal Microbiota Transplant (FMT) with a 300 mL donor fecal suspension delivered via colonoscopy.

Biological: Fecal Microbiota Transplantation

Sham Fecal Microbiota Transplantation

SHAM COMPARATOR

After completing at least a 10 day course of vancomycin for treatment of the most recent acute severe C. difficile infection, subjects will receive a 300 mL infusion of a sham (autotransfusion) fecal solution at colonoscopy.

Biological: Sham Fecal Microbiota Transplantation

Interventions

Fecal Microbiota Transplantation BIOLOGICAL

Fecal microbiota transplantation (FMT) involves administering fecal material from a healthy individual (donor) to a sick patient (with relapsing C. difficile infection) to restore missing components of normal intestinal flora. After completing at least a 10 day course of vancomycin for treatment of the most recent acute C. difficile infection, subjects will receive fecal microbiota transplantation (FMT) with a 300 mL donor fecal suspension delivered via colonoscopy.

Also known as: FMT, fecal bacteriotherapy, fecal flora reconstitution, stool transplant

Fecal Microbiota Transplantation

Sham Fecal Microbiota Transplantation BIOLOGICAL

After completing at least a 10 day course of vancomycin for treatment of the most recent acute C. difficile infection, subjects will receive a sham fecal microbiota transplantation (FMT) with a 300 mL sham fecal suspension delivered via colonoscopy. This sham solution will be a reinfusion of the subject's own stool.

Sham Fecal Microbiota Transplantation

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Adult outpatients (age ≥18 and \<75) referred to one of the study centers after suffering a third (or further) documented episode CDI and
• who have failed to maintain CDI cure after standard therapy with oral vancomycin.
• Previous treatment with at least one course of tapered/pulse dose vancomycin as per SHEA-IDSA C difficile treatment guidelines or -Inability to taper or stop vancomycin without developing diarrhea requiring anti-infective therapy. -

You may not qualify if:

• Patients who are aged 75 years or greater.
• Patients who are pregnant
• Patients who are nursing
• Patients who are incarcerated
• Patients with cognitive impairment or severe neuropsychiatric co morbidities who are incapable of giving their own informed consent
• Patients who are immunocompromised specifically:
• HIV infection (any CD4 count)
• AIDS-defining diagnosis or CD4\<200/mm3
• Inherited/primary immune disorders
• Immunodeficient or Immunosuppressed due to medical condition/medication:
• Current or recent (\<3 most) treatment with anti-neoplastic agent
• Current or recent (\<3 mos) treatment with any immunosuppressant medications (including but not limited to monoclonal antibodies to B and T cells, anti-TNF agents, glucocorticoids, antimetabolites (azathioprine, 6-mercaptopurine), calcineurin inhibitors (tacrolimus, cyclosporine), mycophenolate mofetil). Subjects who are otherwise immunocompetent and have discontinued any immunosuppressant medications 3 or more months prior to enrollment may be eligible to enroll.
• Patients with a history of severe (anaphylactic) food allergy
• Patients who have previously undergone FMT
• Patients who are unwilling or unable to undergo colonoscopy

Sponsors & Collaborators

• Colleen Kelly: lead

Study Sites (2)

Montefiore Medical Center

The Bronx, New York, 10467, United States

Location

The Miriam Hospital

Providence, Rhode Island, 02906, United States

Location

Related Publications (5)

• Khoruts A, Dicksved J, Jansson JK, Sadowsky MJ. Changes in the composition of the human fecal microbiome after bacteriotherapy for recurrent Clostridium difficile-associated diarrhea. J Clin Gastroenterol. 2010 May-Jun;44(5):354-60. doi: 10.1097/MCG.0b013e3181c87e02.

  PMID: 20048681 BACKGROUND

• Persky SE, Brandt LJ. Treatment of recurrent Clostridium difficile-associated diarrhea by administration of donated stool directly through a colonoscope. Am J Gastroenterol. 2000 Nov;95(11):3283-5. doi: 10.1111/j.1572-0241.2000.03302.x. No abstract available.

  PMID: 11095355 BACKGROUND

• Yoon SS, Brandt LJ. Treatment of refractory/recurrent C. difficile-associated disease by donated stool transplanted via colonoscopy: a case series of 12 patients. J Clin Gastroenterol. 2010 Sep;44(8):562-6. doi: 10.1097/MCG.0b013e3181dac035.

  PMID: 20463588 BACKGROUND

• Kelly CR, de Leon L, Jasutkar N. Fecal microbiota transplantation for relapsing Clostridium difficile infection in 26 patients: methodology and results. J Clin Gastroenterol. 2012 Feb;46(2):145-9. doi: 10.1097/MCG.0b013e318234570b.

  PMID: 22157239 BACKGROUND

• Kelly CR, Khoruts A, Staley C, Sadowsky MJ, Abd M, Alani M, Bakow B, Curran P, McKenney J, Tisch A, Reinert SE, Machan JT, Brandt LJ. Effect of Fecal Microbiota Transplantation on Recurrence in Multiply Recurrent Clostridium difficile Infection: A Randomized Trial. Ann Intern Med. 2016 Nov 1;165(9):609-616. doi: 10.7326/M16-0271. Epub 2016 Aug 23.

  PMID: 27547925 DERIVED

MeSH Terms

Interventions

Fecal Microbiota Transplantation

Intervention Hierarchy (Ancestors)

Biological Therapy; Therapeutics

Study Officials

• Colleen R Kelly, MD

  Lifespan/ The Miriam Hospital

  PRINCIPAL INVESTIGATOR

• Lawrence J Brandt, MD

  Montefiore Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Clinical Assistant Professor of Medicine

Study Record Dates

• First Submitted: October 4, 2012
• First Posted: October 10, 2012
• Study Start: October 1, 2012
• Primary Completion: May 1, 2015
• Study Completion: September 1, 2015
• Last Updated: October 1, 2015

Record last verified: 2015-09

Locations

US (2)