Observational Study of Kibow Biotics in Dialysis Patients
Condition: Chronic Kidney Failure
MeSH terms: Renal Insufficiency; Kidney Failure, Chronic
Study type: Observational

Summary: 
      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.
    

Detailed description: 
      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.
    

Intervention name(s): Kibow Biotics
Intervention type(s): Dietary Supplement
Intervention description(s): Month 1, one capsule three times daily (90 Colony forming units); Month 2, two capsules three times daily (180 CFU's); Month 3, three capsules three times daily (270 CFU's). Continued on tolerated maintenance dosage for an additional 6 months. Once tolerated dosage is identified the patient will be continued on that maintenance dosage for an additional 6 months. All medical, physical, clinical, QOL and other parameters will be monitored as well.
Observational model: Cohort
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        Out patient hospital setting
      
Biospecimen description: 
      Blood serum and plasma.
    
Keywords: Probiotics; Kibow Biotics; Dialysis; Gut based uremic toxin removal