Recruiting
Phase 2

Fecal Microbiota Transplantation

Sponsor:

The Miriam Hospital

Code:

NCT02557685

Conditions

Clostridium Difficile Infection

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

Interventions

Fecal Microbiota Transplantation

Study Details

Brief summary:

This study aims to document early changes in the distal gut microbiota (both fecal and mucosa-associated) post FMT. Furthermore, whole blood and urine samples will facilitate collaborative immunologic and metabolomic analyses.

This will be an open label clinical trial of FMT to prevent further recurrence in patients who have suffered at least a third episode of Clostridium difficile infection (CDI) and who have previously been treated with oral vancomycin.

Conditions

Clostridium Difficile Infection

Study ID

NCT02557685

Start date

Jun, 2015

Status verified date

Sep, 2015

Completion date

Mar, 2017

Anticipated

Primary completion date

Mar, 2016

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • Adult outpatients (age ≥18 and ≤90) referred to Dr. Kelly after suffering a third (or further) documented episode CDI and 2) who have failed to maintain CDI cure after standard therapy.

  • 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 anti-CDI therapy without developing diarrhea requiring anti-infective therapy

Exclusion Criteria:

  • • 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 sigmoidoscopy
  • Patients with untreated, in-situ colorectal cancer
  • Patients with a history of inflammatory bowel disease (ulcerative colitis, Crohn's disease or microscopic colitis) or diarrhea-predominant 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.

Study Design

Enrollment

6 participants

Anticipated

Intervention Model

Single group

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

no intervention: Fecal Microbiota Translantation

After completing at least 10 days course of antibiotic treatment for C. difficile infection, subjects will receive Fecal Microbiota transplantation with a 300 mL fecal suspension delivered via sigmoidoscopy.

Interventions

Fecal Microbiota Transplantation

Fecal Microbiota Translantation involves administering fecal material from a healthy donor to a sick patient, with relapsing C-difficile infection, to restore missing components of normal intestinal flora. Subjects will receive Fecal Microbiota Translantation via sigmoidoscopy.

Primary outcome measure

  • Clinical cure [ Time Frame: 8 weeks ]

Central Contacts and Locations

Central contacts

Colleen Kelly, MD

401-793-7396ckelly2@lifespan.org

Locations

The Miriam Hospital

Recruiting

Providence, Rhode Island, United States, 02906

Contacts

Colleen R. Kelly, MD

401-793-7080ckelly2@lifespan.org

Patrizia Curran, MD

401-793-7824pcurran1@lifespan.org

Principal Investigator:

Colleen R. Kelly, MD

More Information

Sponsor

The Miriam Hospital

Last update posted

Sep 23, 2015

Last verified

Sep, 2015

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-12. This information was provided to ClinicalTrials.gov by The Miriam Hospital on 2015-09-23.