Pilot-Scale Clinical Trials of Kibow Biotics® in Chronic Kidney Failure (Probiotics)
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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 |
- 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 ]
| 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 |
|---|
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HSCB, Brooklyn, NY
State University of New York Brooklyn, NY 11203
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2. Nephrology Associates,
Scarborough, ON CANADA, LI H IC5
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3.New York Harbor VA Medical Center
NYU School of Medicine New York, NY.10010
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4.Hospital Juarez De Mexico
Madero, Mexico, D.FC.P. 07760
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5. Hospital Italiano de Buenos Aires
Buenos Aires, Argentina.
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6. National Hospital
Abuja, Nigeria
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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
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, Learn About Clinical Studies.
| Ages Eligible for Study: | 18 Years to 75 Years (Adult, Senior) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
| Sampling Method: | Probability Sample |
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
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00760162
| 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 | |
| Study Chair: | Eli A Friedman, MD | Downstate Medical Center - State University of New York, Brooklyn, NY |
More Information
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 |
| First Submitted: | September 25, 2008 |
| 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:
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Renal Insufficiency Kidney Failure, Chronic Kidney Diseases Urologic Diseases Renal Insufficiency, Chronic |