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

Study Overview
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Brief Summary
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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
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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

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

Conditions
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Chronic Kidney Failure

Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: CKD patients Stage III and IV 18 to 75 years old, able and willing to give an informed consent Baseline serum creatinine > 2.5 mg/dL Exclusion Criteria: Women who are pregnant or nursing Patients who are on antibiotic treatment at the time of screening will be excluded from the study (Patients who have received antibiotics should have stopped them for at least 14 days prior to screening) Patients who do not agree to sign the informed consent form Active dependency on drugs or alcohol Patients with documented Human Immunodeficiency Virus (HIV) infection/ Acquired Immunodeficiency Syndrome (AIDS)/Liver Disease Any medical, psychiatric, debilitating disease/disorder or social condition that in the judgment of the investigator would interfere with or serve as a contraindication to adherence to the study protocol or ability to give informed consent, or affect the overall prognosis of the patient Patients who are on coumadin therapy

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| HSCB, Brooklyn, NY<br>State University of New York Brooklyn, NY 11203 | |
| 2. Nephrology Associates,<br>Scarborough, ON CANADA, LI H IC5 | |
| 3.New York Harbor VA Medical Center<br>NYU School of Medicine New York, NY.10010 | |
| 4.Hospital Juarez De Mexico<br>Madero, Mexico, D.FC.P. 07760 | |
| 5. Hospital Italiano de Buenos Aires<br>Buenos Aires, Argentina. | |
| 6. National Hospital<br>Abuja, Nigeria | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| PRIMARY: Changes in blood chemistry - BUN, Creatinine and Uric acid |  | six months | 
| Changes in BUN, Creatinine and uric acid levels |  | six months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Chronic Kidney failure stage three and four, Probiotics, Kibow Biotics, Enteric Dialysis, Gut based removal uremic toxin removal