Immunosuppressant Associated Diarrhea Clinical Trial
Official title:
Probiotic Prophylaxis for Immunosuppressant Associated Diarrhea (IAD) Following Kidney Transplantation: a Single Center Randomized Controlled Trial
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.
Immunosuppression following organ transplantation is associated with a myriad of
gastrointestinal complications including severe diarrhea. Mycophenolate mofetil (MMF) is the
immunosuppressant most often associated with this plaguing symptom. A retrospective study of
patients from 10 US transplant centers receiving MMF immunosuppression after kidney
transplantation showed that nearly 50% of patients suffered from at least one
gastrointestinal symptom within the first 6 months after transplantation. (Tierce 2005) The
majority of these patients have diarrhea. However, Immunosuppression Associated Diarrhea
(IAD) is often observed in association with other immunosuppressive agents as well. It is
the investigator's observation that IAD is equally problematic whether the immunosuppressive
regimen includes MMF or not. When IAD is severe it can be difficult for the recipient to
maintain adequate levels of immunosuppression. Not infrequently, IAD is so distressing that
a recipient's immunosuppressive medications are tapered, changed or stopped. During these
times of drug manipulation, patients are at risk for early acute rejection. Approximately
30% of renal transplant patients who have their MMF regimen adjusted or discontinued suffer
an episode of acute rejection. Reversing a rejection episode is expensive and adds
significant risks for the recipient and long-term allograft survival. Thus, a strategy to
support and maintain normal healthy bowel function moderating or obviating IAD is highly
desirable.
Repopulation of the normal intestinal microflora in kidney transplant patients after kidney
transplantation may maintain normal bowel function. This study is designed to test the
hypothesis that the administration of a food supplement probiotic consisting of high amounts
of six strains of lactic acid bacteria normally found in the human colon will favorably
support and maintain bowel function moderating or obviating IAD.
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Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Prevention