Status:
COMPLETED
Fecal Microbiota Transplant
Lead Sponsor:
Methodist Health System
Conditions:
Clostridium Difficile Infection
Eligibility:
All Genders
Phase:
PHASE4
Brief Summary
The study will provide data to show the effectiveness of Fecal Microbiota Transplant in patients with recurrent Clostridium difficile infection. Fecal Microbiota Transplant (FMT) is a procedure in wh...
Detailed Description
Methodist Health System wishes to offer transplant services to our CDI populations which meet all criteria for recurrent intractable disease. The objective is to reduce the cost both financially and p...
Eligibility Criteria
Inclusion
- Recurring CDI after three episodes of mild to moderate C Diff infections and failure to respond to appropriate antimicrobial treatment of six to eight weeks.
- Metronidazole
- Vancomycin
- At least two episodes of severe C diff infection that have required hospitalization and significant morbidity within one year
- Severe C Diff infection requiring hospitalization and non- responsive to maximal medication therapy
Exclusion
- advanced Human Immunodeficiency Virus (HIV) or Acquired Immunodeficiency Syndrome (AIDS)
- cirrhosis of the liver
- recent bone marrow transplants
- medication suppressed immune systems (allowed per physician discretion if benefit outweighs risk)
- pregnancy
- Toxic megacolon or ileus present
Key Trial Info
Start Date :
June 5 2018
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 30 2022
Estimated Enrollment :
24 Patients enrolled
Trial Details
Trial ID
NCT04090346
Start Date
June 5 2018
End Date
March 30 2022
Last Update
March 28 2024
Active Locations (1)
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1
Methodist Mansfield Medical Center
Dallas, Texas, United States, 75203