Probiotic Prophylaxis for Immunosuppressant Associated Diarrhea (IAD) Following Kidney Transplantation
Completed · Not applicable · Has a placebo group
Conditions studied: Immunosuppressant Associated Diarrhea
In brief
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 Diarrhea following kidney transplantation.
Key facts
- Study ID
- NCT00364650
- Run by
- Swedish Medical Center
- People needed
- 44
- Starts
- 2006-07-01
- Expected to finish
- 2009-12-01
- Last updated by the study team
- 2011-07-26
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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
You may not qualify if…
- 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
Where it is running
- Swedish Medical Center — Seattle, Washington, United States
Full record on ClinicalTrials.gov
Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.