Status:
COMPLETED
Probiotic Prophylaxis for Immunosuppressant Associated Diarrhea (IAD) Following Kidney Transplantation
Lead Sponsor:
Swedish Medical Center
Collaborating Sponsors:
Hoffmann-La Roche
Conditions:
Immunosuppressant Associated Diarrhea
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
We hypothesize that the administration of a combination of high numbers of probiotic bacteria will maintain normal bowel function and significantly moderate or obviate Immunosuppression Associated Dia...
Detailed Description
Immunosuppression following organ transplantation is associated with a myriad of gastrointestinal complications including severe diarrhea. Mycophenolate mofetil (MMF) is the immunosuppressant most oft...
Eligibility Criteria
Inclusion
- all subjects aged \>/= 18 years who qualify to receive a living (related or unrelated) or cadaveric kidney allograft using steroid free induction immunosuppression.
- single organ recipient (kidney only)
- subjects receiving first or second renal transplant
- women of child-bearing potential should have a negative serum pregnancy test within 1 week prior to beginning study medications
- subjects with no known contraindications to treatment with any of the study drugs
- subjects providing written consent
- subjects who are compliant and able to complete all the necessary assessment procedures
Exclusion
- Subjects \< 18 years of age
- Subjects who do not meet criteria for steroid free protocol
- subjects with known intolerance to lactobacillus
- subjects with history of chronic diarrhea
- subjects with history of gastrointestinal disorder that may interfere with their ability to absorb oral medication: inflammatory bowel disease, irritable bowel syndrome, short gut syndrome, or ileo jejunal surgery
- subjects with known laxative abuse
- subjects with pancreatic insufficiency
- subjects who are pregnant, lactating or nursing
- subjects with active peptic ulcer disease
- child bearing women not willing to use a reliable form of contraception
- subjects with prior history of C. difficile
- subjects receiving other medications considered to be experimental for control of diarrhea
Key Trial Info
Start Date :
July 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2009
Estimated Enrollment :
44 Patients enrolled
Trial Details
Trial ID
NCT00364650
Start Date
July 1 2006
End Date
December 1 2009
Last Update
July 26 2011
Active Locations (1)
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1
Swedish Medical Center
Seattle, Washington, United States, 98122