Now Available for Public Comment: Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

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

This study has been completed.
Sponsor:
Information provided by:
Kibow Biotech Inc.
ClinicalTrials.gov Identifier:
NCT00760162
First received: September 25, 2008
Last updated: August 2, 2011
Last verified: August 2011

September 25, 2008
August 2, 2011
August 2007
July 2009   (final data collection date for primary outcome measure)
  • PRIMARY: Changes in blood chemistry - BUN, Creatinine and Uric acid [ Time Frame: six months ] [ Designated as safety issue: Yes ]
  • Changes in BUN, Creatinine and uric acid levels [ Time Frame: six months ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT00760162 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
Not Provided
 
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

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

Observational
Observational Model: Cohort
Time Perspective: Prospective
Not Provided
Not Provided
Probability Sample

Out patient Hospital setting

Chronic Kidney Failure
Not Provided
  • 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
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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
180
August 2009
July 2009   (final data collection date for primary outcome measure)

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
Both
18 Years to 75 Years
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00760162
KIB001
Yes
Dr. Natarajan Ranganathan, Senior VP (R&D and Operations), Kibow Biotech Inc
Kibow Biotech Inc.
Not Provided
Study Chair: Eli A Friedman, MD Downstate Medical Center - State University of New York, Brooklyn, NY
Kibow Biotech Inc.
August 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP