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

Study Description

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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Brief 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

Condition or disease
Chronic Kidney Failure

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

Study Design

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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Study Type :	Observational
Actual Enrollment :	180 participants
Observational Model:	Cohort
Time Perspective:	Prospective
Official Title:	Pilot-Scale Clinical Trials of Kibow Biotics® (a Patented and Proprietary Probiotic Formulation) in Chronic Kidney Failure
Study Start Date :	August 2007
Actual Primary Completion Date :	July 2009
Actual Study Completion Date :	August 2009

Groups and Cohorts

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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

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

Outcome Measures

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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Primary Outcome Measures :

1. PRIMARY: Changes in blood chemistry - BUN, Creatinine and Uric acid [ Time Frame: six months ]
2. Changes in BUN, Creatinine and uric acid levels [ Time Frame: six months ]

Eligibility Criteria

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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Ages Eligible for Study:	18 Years to 75 Years (Adult, Senior)
Sexes Eligible for Study:	All
Accepts Healthy Volunteers:	No
Sampling Method:	Probability Sample

Study Population

Out patient Hospital setting

Criteria

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

Contacts and Locations

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Locations

United States, New York
Downstate Medical Center,HSCB, State University of New York
Brooklyn, New York, United States, 11203
SUNY DownState Medical Center-Renakl Division
Brooklyn, New York, United States, 11203

Sponsors and Collaborators

Kibow Biotech Inc.

Investigators

Study Chair:	Eli A Friedman, MD	Downstate Medical Center - State University of New York, Brooklyn, NY

More Information

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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Ranganathan N, Friedman EA, Tam P, Rao V, Ranganathan P, Dheer R. Probiotic dietary supplementation in patients with stage 3 and 4 chronic kidney disease: a 6-month pilot scale trial in Canada. Curr Med Res Opin. 2009 Aug;25(8):1919-30. doi: 10.1185/03007990903069249.

Responsible Party:	Dr. Natarajan Ranganathan, Senior VP (R&D and Operations), Kibow Biotech Inc
ClinicalTrials.gov Identifier:	NCT00760162 History of Changes
Other Study ID Numbers:	KIB001
First Posted:	September 26, 2008
Last Update Posted:	August 3, 2011
Last Verified:	August 2011

Keywords provided by Kibow Biotech Inc.:

Chronic Kidney failure stage three and four; Probiotics; Kibow Biotics; Enteric Dialysis; Gut based removal uremic toxin removal

Additional relevant MeSH terms:

Renal Insufficiency; Kidney Failure, Chronic; Kidney Diseases; Urologic Diseases; Renal Insufficiency, Chronic