Observational Study of Kibow Biotics in Chronic Kidney Failure Patients on Dialysis

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01450709
Recruitment Status : Unknown
Verified May 2012 by Kibow Biotech Inc..
Recruitment status was:  Recruiting
First Posted : October 12, 2011
Last Update Posted : May 3, 2012
State University of New York - Downstate Medical Center
Information provided by (Responsible Party):
Kibow Biotech Inc.

September 26, 2011
October 12, 2011
May 3, 2012
April 2011
September 2012   (Final data collection date for primary outcome measure)
  • 15-20% Changes in BUN. [ Time Frame: 6 months ]
  • 15-20% Changes in Creatinine [ Time Frame: 6 months ]
  • 15-20% Changes in CRP [ Time Frame: 6 months ]
  • 15-20% Changes in Uric Acid Levels [ Time Frame: 6 months ]
Same as current
Complete list of historical versions of study NCT01450709 on Archive Site
  • Quality of life outcome based on SF 36 questionnaire. [ Time Frame: 6 months ]
  • To observe inflammatory and oxidative stress biomarkers. [ Time Frame: 6 months ]
    Observe inflammatory markers IL-1beta, NF-kappaB, Protein Bound Pentosidine, Beta2 Microglobulin, Indoxyl sulfate, Phenols, p-cresols, and guanadine metabolites from blood serum.
  • Observation and analysis of patient fecal matter. [ Time Frame: 6 months ]
    Observation and analysis of patient fecal matter to determine bacterial flora levels that are present in the stool.
Same as current
Not Provided
Not Provided
Observational Study of Kibow Biotics in Chronic Kidney Failure Patients on Dialysis
Observational Clinical Trials of Kibow Biotics® (a Patented and Proprietary Probiotic Formulation) in Dialysis Patients, in Conjunction With Standardized Care of Treatment
A specifically formulated probiotic product comprised of defined and tested microbial strains may afford renoprotection in what has been generally called "Enteric DialysisTM". However, it is also referred to as enteric toxin reduction technology. Our hypothesis is to assess the potential benefits in devising a bowel-based probiotic formulation (Kibow® Biotics/RenadylTM) as a dietary supplement product for patients undergoing dialysis along with standardized care of treatment.

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, as a dietary supplement.

Extensive in vitro R&D investigations in Kibow's laboratories

Bacterial strains studied were a mixture of patented and proprietary strains of 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® in cats and dogs (of both genders and varying body weights) with moderate to severe kidney failure. Based on positive results, this formulation, marketed and distributed as AzodylTM, is currently licensed for veterinary applications to Vetoquinol USA.

Pilot scale studies, double blind, placebo controlled, cross-over studies for six months conducted in 45 patients in USA, Canada, Argentina, and Nigeria demonstrates reduction of BUN (P>95%) and improved quality of life (P>95%). Decrease in creatinine and uric acid levels were also observed. However, these studies were based on correlating the age of geriatric cats and dogs with moderate to significant kidney failure to human geriatric conditions.

Observational Model: Cohort
Time Perspective: Prospective
Not Provided
Retention:   Samples With DNA
Blood serum, plasma and lymphocytes.
Probability Sample
Out patient hospital setting
Chronic Kidney Disease
Dietary Supplement: Kibow Biotics
6 month, double-blind, cross-over, wash-out, placebo controlled study in an outpatient setting. Each patient takes two capsules, three times a day (180 CFU/day).
Dialysis patients
Intervention: Dietary Supplement: Kibow Biotics

*   Includes publications given by the data provider as well as publications identified by Identifier (NCT Number) in Medline.
Unknown status
Same as current
October 2012
September 2012   (Final data collection date for primary outcome measure)

Inclusion Criteria:

  • Currently on hemodialysis
  • 18 to 75 years of age
  • Willing to give informed consent
  • Baseline serum creatinine >2.5 mg/dL

Exclusion Criteria:

  • Pregnant or nursing women
  • Refusal to sign the informed consent form
  • Documented to have HIV/AIDS/Liver disease
  • Active dependency on drugs or alcohol
  • Currently on anticoagulant therapy
Sexes Eligible for Study: All
18 Years to 75 Years   (Adult, Older Adult)
Contact information is only displayed when the study is recruiting subjects
United States
Not Provided
Not Provided
Kibow Biotech Inc.
Kibow Biotech Inc.
State University of New York - Downstate Medical Center
Principal Investigator: Subodh J Saggi, M.D., MPH Downstate Medical Center
Principal Investigator: Mary Mallapallil, M.D. Kings County Medical Center
Principal Investigator: Eli Friedman, M.D., MACP, FRCP Downstate Medical Center
Principal Investigator: Gary Briefel, M.D. Kings County Medical Center
Kibow Biotech Inc.
May 2012