Gut Microbiota Changes After Fecal Microbiota Transplantation

Status unconfirmed · Phase 2

Conditions studied: Clostridium Difficile Infection

In brief

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.

Key facts

Study ID

NCT02557685

Run by

The Miriam Hospital

People needed

6

Starts

2015-06-01

Expected to finish

2017-03-01

Last updated by the study team

2015-09-23

Who can join

Age: 18 and older, up to 90. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• • 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.

Where it is running

• The Miriam Hospital — Providence, Rhode Island, United States (enrolling)

Full record on ClinicalTrials.gov

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