Clinical Trial Summaries > Probiotic Prophylaxis for Immunosuppressant...

March 2006

Klaire Labs™, a division of ProThera®, Inc. received approval from the Western Institutional Review Board® (WIRB®) to initiate a clinical trial assessing the potential benefit of probiotic supplementation in maintaining normal bowel function in renal transplant patients. The Phase II study is to be conducted by William H. Marks, M.D., Ph.D., Director of Organ Transplantation at Swedish Medical Center, Seattle, Washington. Stephen Olmstead, M.D., Chief Science Officer for Klaire Labs and ProThera, Inc., will be actively collaborating on this important clinical trial.

The study will assess whether administration of a specific blend of probiotic strains will help reduce the incidence of immunosuppressant-associated diarrhea, a common and potentially life-threatening complication of organ transplantation. Sixty-four subjects will be recruited over a two-year period to participate in this randomized, double-blind, placebo-controlled trial. Patients will receive either a standardized probiotic supplement or placebo for a five-month test period and will be monitored to assess the effect on bowel function.

“We are honored that Klaire Labs has been selected by Swedish Medical Center to supply the probiotic supplement and to collaborate on this important clinical trial”, said Dr. Olmstead. “Probiotics have demonstrated significant benefit for maintaining normal bowel function in people with diarrhea from various other causes. We are hopeful that these benefits will extend to renal transplant patients.”