Observational Study of Kibow Biotics in Dialysis Patients

• 15-20% Changes in BUN. [ Time Frame: 12 months ] [ Designated as safety issue: No ]
  
• 15-20% Changes in Creatinine [ Time Frame: 12 months ] [ Designated as safety issue: No ]
  
• 15-20% Changes in CRP [ Time Frame: 12 Months ] [ Designated as safety issue: No ]
  
• 15-20% Change in Uric Acid Levels [ Time Frame: 12 Months ] [ Designated as safety issue: No ]
  

• Quality of life outcome based on SF 36 questionnaire. [ Time Frame: 12 months ] [ Designated as safety issue: No ]
  
• To observe inflammatory and oxidative stress biomarkers. [ Time Frame: 12 months ] [ Designated as safety issue: No ]
  Observe inflammatory markers IL-1beta, NF-kappaB, Protein Bound Pentosidine, Beta2 Microglobulin, Indoxyl sulfate, Phenols, p-cresols, and guanadine metabolites from blood serum.
  
  

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.