Chronic Kidney Failure Clinical Trial
Official title:
Observational Clinical Trials of Kibow Biotics (a Patented and Proprietary Probiotic Dietary Supplement) in Dialysis Patients, in Conjunction With Standardized Care of Treatment
A specifically formulated probiotic product comprised of defined and tested microbial strains may afford renoprotection in what has been generally called "Enteric DialysisTM". However, it is also referred to as enteric toxin reduction technology. Our hypothesis is to assess the potential benefits in devising a bowel-based probiotic formulation (Kibow® Biotics/RenadylTM) as a dietary supplement product for patients undergoing dialysis along with standardized care of treatment.
Probiotics are increasingly utilized clinically. As their safety and health benefits are
established, it is reasonable to anticipate that probiotic bacteria will be incorporated into
a growing number of clinical regimens, as a dietary supplement.
Extensive in vitro R&D investigations in Kibow's laboratories
Bacterial strains studied were a mixture of patented and proprietary strains of Streptococcus
thermophilus (KB27), Lactobacillus acidophilus (KB31) and Bifidobacterium longum (KB35).
Oral administration of these bacterial formulations, tested in the 5/6th nephrectomized rat
model (at Thomas Jefferson University, Phila., PA) and minipig model (at Indiana University,
Indianapolis, IN), decreased both blood urea nitrogen (BUN) and serum creatinine (Scr)
levels.
Two independent veterinarians investigated the effect of Kibow Biotics® in cats and dogs (of
both genders and varying body weights) with moderate to severe kidney failure. Based on
positive results, this formulation, marketed and distributed as AzodylTM, is currently
licensed for veterinary applications to Vetoquinol USA.
Pilot scale studies, double blind, placebo controlled, cross-over studies for six months
conducted in 45 patients in USA, Canada, Argentina, and Nigeria demonstrates reduction of BUN
(P>95%) and improved quality of life (P>95%). Decrease in creatinine and uric acid levels
were also observed. However, these studies were based on correlating the age of geriatric
cats and dogs with moderate to significant kidney failure to human geriatric conditions. The
proposed current study is being reevaluated based on correlating the weight basis of animal
to human conditions. Hence, this is a does escalation study on ingestion of 1x (90 billion
CFU/day), 2x (180 billion CFU/day), and 3x (270 billion CFU/day) dosages.
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