Observational Study of Kibow Biotics in Chronic Kidney Failure Patients on Dialysis
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.
|Study Design:||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|
- 15-20% Changes in BUN. [ Time Frame: 6 months ] [ Designated as safety issue: No ]
- 15-20% Changes in Creatinine [ Time Frame: 6 months ] [ Designated as safety issue: No ]
- 15-20% Changes in CRP [ Time Frame: 6 months ] [ Designated as safety issue: No ]
- 15-20% Changes in Uric Acid Levels [ Time Frame: 6 months ] [ Designated as safety issue: No ]
- Quality of life outcome based on SF 36 questionnaire. [ Time Frame: 6 months ] [ Designated as safety issue: No ]
- To observe inflammatory and oxidative stress biomarkers. [ Time Frame: 6 months ] [ Designated as safety issue: No ]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 ] [ Designated as safety issue: No ]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.
|Study Start Date:||April 2011|
|Estimated Study Completion Date:||October 2012|
|Estimated Primary Completion Date:||September 2012 (Final data collection date for primary outcome measure)|
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).
Other Name: Kibow Biotics
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.
|Contact: Subodh J Saggi, M.D., MPHfirstname.lastname@example.org|
|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|
|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|