Artificial Swallowable Kidney Formulation

B.G.Patel, N.Ranganathan and E.A. Friedman. Kibow Biotech Inc., Philadelphia, PA, Department of medicine, SUNY Brooklyn Health Science Center, NY. American Society of Artificial and Internal Organs
International Society of Artificial and Internal Organs Joint Conference 2003
Poster #126

Kidney dysfunction is a widely spread disorder that often occurs as a consequence of other diseases such as diabetes or hypertension. This makes millions of people potential candidates for dialysis or kidney transplants. Kibow Biotech Inc. is exploring “enteric dialysis” as an alternative strategy in treating kidney failure. In renal patients potentially toxic solutes (urea, creatinine, uric acid, etc.) accumulate in the blood and flow into the gut by passive diffusion. We are developing a product that may serve as an artificial kidney through removal of uremic toxins by gut-friendly microorganisms.

Bacillus pasteurii, the urealytic spore forming soil bacterium, may be a good candidate for such an organism. Our in vitro data indicated that spores survive low pH of the gastric juice for at least 2 hours with only 2log loss in viability. 5/6th nephrectomized rat trials showed that bacterium may be considered non-pathogenic. In the present study the effect of B. pasteurii on the microbial composition and chemical equilibrium of the human intestine has been tested in the Simulator of the Human Intestinal Microbial Ecosystem (SHIME, Ghent University, Belgium). Supplementation with 2x109cfu/ml daily for two weeks did not alter the composition and/or normal functioning of the microbial community in the SHIME. The data on fermentative capacity suggest that B. pasteurii was mainly active in the colon transversum and its effect on the chemical equilibrium, if any, can be considered beneficial for the colonocytes. In the environment of the SHIME B. pasteurii removed up to 60% of urea in less than 24 hours (p=0.01, n=3).

Bacillus pasteurii:
Gram positive, spore former, soil borne microbe
Spores are stable at room temperature
Resistant to gastric juice and bile
Isolated from human micro flora as a contaminant

Purpose of SHIME study:
Proliferation of B. pasteurii
Catabolism of urea
Effect of B. pasteurii on microbial community
Fermentation activity