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
  Purpose

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
Chronic Kidney Failure

Study Type: Observational
Study Design: 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

Resource links provided by NLM:


Further study details as provided by Kibow Biotech Inc.:

Primary Outcome Measures:
  • 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 ]

Enrollment: 180
Study Start Date: August 2007
Study Completion Date: August 2009
Primary Completion Date: July 2009 (Final data collection date for primary outcome measure)
Groups/Cohorts
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

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

  Eligibility

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00760162

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

No publications provided by Kibow Biotech Inc.

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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
Study First Received: September 25, 2008
Last Updated: August 2, 2011
Health Authority: United States: Food and Drug Administration
Canada: Ethics Review Committee
Argentina: Human Research Bioethics Committee
Mexico: Ethics Committee
Nigeria: The National Agency for Food and Drug Administration and Control

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

ClinicalTrials.gov processed this record on September 16, 2014