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Probiotic Prophylaxis for Immunosuppressant Associated Diarrhea (IAD) Following Kidney Transplantation

2014-08-27 03:43:01 | BioPortfolio

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 Diarrhea following kidney transplantation.

Description

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.

Study Design

Allocation: Randomized, Control: Placebo Control, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Prevention

Conditions

Renal Transplantation

Intervention

Probiotic Supplement, Placebo

Location

Swedish Medical Center
Seattle
Washington
United States
98122

Status

Completed

Source

Swedish Medical Center

Results (where available)

View Results

Links

Published on BioPortfolio: 2014-08-27T03:43:01-0400

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Medical and Biotech [MESH] Definitions

General dysfunction of an organ occurring immediately following its transplantation. The term most frequently refers to renal dysfunction following KIDNEY TRANSPLANTATION.

Preparative treatment of transplant recipient with various conditioning regimens including radiation, immune sera, chemotherapy, and/or immunosuppressive agents, prior to transplantation. Transplantation conditioning is very common before bone marrow transplantation.

Transfer of HEMATOPOIETIC STEM CELLS from BONE MARROW or BLOOD between individuals within the same species (TRANSPLANTATION, HOMOLOGOUS) or transfer within the same individual (TRANSPLANTATION, AUTOLOGOUS). Hematopoietic stem cell transplantation has been used as an alternative to BONE MARROW TRANSPLANTATION in the treatment of a variety of neoplasms.

An organism that, as a result of transplantation of donor tissue or cells, consists of two or more cell lines descended from at least two zygotes. This state may result in the induction of donor-specific TRANSPLANTATION TOLERANCE.

Transplantation between individuals of the same species. Usually refers to genetically disparate individuals in contradistinction to isogeneic transplantation for genetically identical individuals.

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