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

Swedish Medical Center

Status

Completed

Conditions

Immunosuppressant Associated Diarrhea

Treatments

Other: Placebo

Drug: Probiotic Supplement

Study type

Interventional

Funder types

Other

Industry

Identifiers

NCT00364650

CEL346 (Main)

Details and patient eligibility

About

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.

Full 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.

Enrollment

44 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

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 criteria

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