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

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ClinicalTrials.gov 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
Sponsor:
Collaborator:
State University of New York - Downstate Medical Center
Information provided by (Responsible Party):
Kibow Biotech Inc.

Brief Summary:
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.

Condition or disease Intervention/treatment
Chronic Kidney Disease Dietary Supplement: Kibow Biotics

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, 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.


Study Type : Observational
Estimated Enrollment : 30 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Observational Clinical Trials of Kibow Biotics® (a Patented and Proprietary Probiotic Formulation) in Dialysis Patients, in Conjunction With Standardized Care of Treatment
Study Start Date : April 2011
Estimated Primary Completion Date : September 2012
Estimated Study Completion Date : October 2012

Group/Cohort Intervention/treatment
Dialysis patients 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).



Primary Outcome Measures :
  1. 15-20% Changes in BUN. [ Time Frame: 6 months ]
  2. 15-20% Changes in Creatinine [ Time Frame: 6 months ]
  3. 15-20% Changes in CRP [ Time Frame: 6 months ]
  4. 15-20% Changes in Uric Acid Levels [ Time Frame: 6 months ]

Secondary Outcome Measures :
  1. Quality of life outcome based on SF 36 questionnaire. [ Time Frame: 6 months ]
  2. 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.

  3. 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.


Biospecimen Retention:   Samples With DNA
Blood serum, plasma and lymphocytes.


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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:

  • 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

Information from the National Library of Medicine

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): NCT01450709


Contacts
Contact: Subodh J Saggi, M.D., MPH 718-703-5945 subodh.saggi@downstate.edu

Locations
United States, New York
Parkside Dialysis Clinic at Downstate Medical Center Recruiting
Brooklyn, New York, United States, 11226
Principal Investigator: Subodh J Saggi, M.D., MPH         
Sponsors and Collaborators
Kibow Biotech Inc.
State University of New York - Downstate Medical Center
Investigators
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