Status:
ENROLLING_BY_INVITATION
Defined Fecal Microbiota Transplantation for Clostridium Difficile Diarrhea
Lead Sponsor:
Baylor College of Medicine
Collaborating Sponsors:
Michael E. DeBakey VA Medical Center
Conditions:
Active C. Difficile Colitis
Eligibility:
All Genders
18+ years
Phase:
PHASE1
Brief Summary
The study is on indefinite HOLD due to the loss of funding that occurred during the pandemic emergency. Subsequently, a key collaborator left our institution, and as a near-term result, the protocol a...
Detailed Description
This study will initially enroll 12 subjects. Based on the relatively large experience with FMT reported to date, we anticipate a prompt and sustained response as determined by a cessation of fever, l...
Eligibility Criteria
Inclusion
- Only VA patients will be eligible for the study if they have had a confirmed diagnosis of CDI that has been treated for 10-14 days with recommended doses of metronidazole or vancomycin and has either failed to respond, or has responded and relapsed within 4 weeks of the end of treatment. The diagnosis will be regarded as confirmed by the presence of diarrhea (\>3 unformed stools in a 24-hour period for 2 successive days) and abdominal discomfort. The presence of fever, leukocytosis, and a serum albumin \<3 gm/dL will be recorded but will not be necessary for the diagnosis. Patients will be included after they have given informed consent and signed the appropriate consent form that has been approved by the Baylor IRB.
Exclusion
- Exclusion criteria include: treatment with major immunosuppressive agents including prednisone \>10 mg/day (or its equivalent), calcineurin inhibitors, mammalian target of rapamycin (mTOR) inhibitors, lymphocyte-depleting biological agents, anti-tumor necrosis factor agents, and others; chemotherapeutic antineoplastic agents; decompensated liver cirrhosis; serum creatinine \>4 or need for hemodialysis; presence of an active malignancy other than superifical skin cancer (eg, basal cell); HIV/acquired immune deficiency syndrome; recent bone marrow transplant, or other cause of severe immunodeficiency; requirement for concurrent antimicrobial therapy; contraindication for ultra-slim endoscopy including severe chronic heart or lung disease; a chronic bedridden state; and any other condition suggesting that life span will not be \>1 yr.
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Key Trial Info
Start Date :
February 28 2013
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
February 28 2036
Estimated Enrollment :
12 Patients enrolled
Trial Details
Trial ID
NCT01868373
Start Date
February 28 2013
End Date
February 28 2036
Last Update
June 27 2023
Active Locations (1)
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1
Michael E DeBakey Veterans Affairs Medical Center
Houston, Texas, United States, 74030