Significance of Dosage for Effective Clinical Application of Probiotics
T Chordia, MB 1, R Dheer, BS 1, B Pechenyak 1, J Marczely, BS 1, B Patel, PhD 1, P Ranganathan, MS MT ASCP 1, N Ranganathan, PhD* 1 and E A Friedman, MD* 2.
1 Kibow Biotech Inc, Philadelphia, PA, United States and 2 Dept. of Med., Downstate Medical Center, Brooklyn, NY, United States Journal of the American Society of Nephrology 15: Oct 2004 pp. 770A PUB039
Our company is researching and developing a cocktail of friendly microbes known as probiotics. These are commonly found in dairy foods such as milk, yogurt, cheese and other fermented products. Our patented and proprietary formulation is known as Kibowbiotics™, the first generation of which is composed of L. acidophilus, S. thermophilus and B. Longum (total of approx 109 to 1011 CFU/g). As has been reported (2003 ASN meeting, San Diego), in vitro lab studies and Simulated Human Intestinal Microbial Ecosystem studies in synthetic intestinal fluid fortified with uremic solutes produced positive data for removal of nitrogenous uremic metabolites (such as urea, uric acid and creatinine) by our first generation product formulation. For comparative purposes, we obtained and investigated over 20 commercially sold probiotic products containing either a single strain or several mixed microbial strains ranging in count between 107 and 1010 CFU/g, with one exception of 1011 CFU/g (brand X).
All of these commercial probiotics were assessed for their in vitro urea utilization characteristics and compared with our first generation product formulation in a urea fortified synthetic intestinal fluid system. None of the commercially sold probiotics, except for brand X, demonstrated comparable urea utilization profile. This product contained several different bacteria, including S. thermophilus, Lactobacilli and Bifidobacteria in the amount of 1.5 x 1011CFU/g. Kibowbiotics™ formulated with similar but specifically screened and selected microbes also contained approximately 1.5 X 1011 CFU/g. These in vitro data strongly affirm that specific strains of probiotics can impart intestinal health benefits as has been defined in the literature only if ingested in sufficiently large amounts.