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

• Status: Completed
• Trial end date: 2009-12-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: N/A
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Swedish Medical Center
• Collaborator: Hoffmann-La Roche
• Treatments: Immunosuppressive Agents

Criteria

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