Fecal Transplant for Relapsing C. Difficile Infection
Status unconfirmed · Phase 2 · Has a placebo group
Conditions studied: Clostridium Difficile
In brief
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.
Key facts
- Study ID
- NCT01703494
- Run by
- Colleen Kelly
- People needed
- 53
- Starts
- 2012-10-01
- Expected to finish
- 2015-09-01
- Last updated by the study team
- 2015-10-01
Who can join
Age: 18 and older, up to 75. Sex: any. Healthy volunteers: accepted.
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
- Patients with untreated, in-situ colorectal cancer
- Patients with a history of inflammatory bowel disease (ulcerative colitis, Crohn"s disease or microscopic colitis) or irritable bowel syndrome
- Unable to comply with protocol requirements
- Patients who are American Society of Anesthesiologists (ASA) Physical Status classification IV and V
- Patients with acute illness or fever on the day of planned FMT will be excluded (not undergo randomization or treatment with FMT) with the option of including that subject at a future date.
Where it is running
- Montefiore Medical Center — The Bronx, New York, United States
- The Miriam Hospital — Providence, Rhode Island, United States
Full record on ClinicalTrials.gov
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