NCT00760162

Pilot-Scale Clinical Trials of Kibow Biotics® in Chronic Kidney Failure

Pilot-Scale Clinical Trials of Kibow Biotics® (a Patented and Proprietary Probiotic Formulation) in Chronic Kidney Failure

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 180 (actual)
• Sponsor: Kibow Pharma · Industry
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

The bowel can serve as a complement to the kidneys' excretory function A specifically formulated probiotic product comprised of defined and tested microbial strains may afford renoprotection in what has been called "enteric dialysis"® Confirm the alleviation of uremic syndrome hypothesis Determine the outcome of probiotics treatment Confirm U.S. FDA's Generally Recognized As Safe (GRAS) status - if needed

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. Following exploratory testing of orally administered probiotic bacteria in rats and minipigs with surgically induced chronic kidney disease (CKD), a trial is now in progress to determine whether daily treatment with gastrointestinal (GI) probiotic bacteria will delay the onset of and/or improve established signs and symptoms of human CKD. To assess the potential benefit in devising a gut-based probiotic formulation (Kibow Biotics®) as a dieatary supplement - Over The Counter (OTC)product in CKD applications. Extensive in vitro R\&D investigations in Kibow's laboratories Simulated Human Intestinal Microbial Ecosystem (SHIME, Ghent University, Belgium) utilized in a computer-controlled in vitro system validated the concept that the chosen microbial formulation would metabolize and reduce concentration of nitrogenous components including urea, creatinine, and uric acid. Bacterial strains studied were 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® on clinically manifested renal failure in uremic cats and dogs of both genders and varying body weights. Based on positive results, this formulation, marketed and distributed as AzodylTM, is currently licensed for veterinary applications to Vetoquinol USA

Conditions

• Chronic Kidney Failure

Timeline

• Start date: 2007-08-01
• Primary completion: 2009-07-01
• Completion: 2009-08-01
• First posted: 2008-09-26
• Last updated: 2019-08-20

Locations

2 sites across 1 country: United States