An observational study in Chronic Kidney Failure, sponsored by Kibow Pharma. Completed at 2 sites in United States. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2019-08-20.
Sponsored by Kibow Pharma · Observational
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
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
1,995 studies on the registry are indexed under Renal Insufficiency; 173 are open to participants now.
This study's enrollment of 180 is above the median of 149 across 394 observational studies indexed under Renal Insufficiency.
Browse Renal Insufficiency studies →Kibow Pharma is the lead sponsor of 6 studies on the registry; none are open to participants now.
Counted across the registry records on this site, refreshed daily.
Out patient Hospital setting
Exclusion Criteria:
State University of New York Brooklyn, NY 11203
Scarborough, ON CANADA, LI H IC5
NYU School of Medicine New York, NY.10010
Madero, Mexico, D.FC.P. 07760
Buenos Aires, Argentina.
Abuja, Nigeria
PRIMARY: Changes in blood chemistry - BUN, Creatinine and Uric acid
Time frame: six months
Changes in BUN, Creatinine and uric acid levels
Time frame: six months
This study is completed, as verified in Aug 2019. You cannot join it, but the record below documents what was studied.
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Kibow Pharma