Observational Study of Kibow Biotics in Dialysis Patients
- Conditions
- Chronic Kidney Failure
- Interventions
- Dietary Supplement: Kibow Biotics
- Registration Number
- NCT01450670
- Lead Sponsor
- Kibow Pharma
- 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.
- 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. The proposed current study is being reevaluated based on correlating the weight basis of animal to human conditions. Hence, this is a does escalation study on ingestion of 1x (90 billion CFU/day), 2x (180 billion CFU/day), and 3x (270 billion CFU/day) dosages.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 30
- Currently on hemodialysis
- 18 to 75 years of age
- Willing to give informed consent
- Baseline serum creatinine >2.5 mg/dL
- 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
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description Dialysis patients Kibow Biotics -
- Primary Outcome Measures
Name Time Method 15-20% Changes in BUN. 12 months 15-20% Changes in Creatinine 12 months 15-20% Changes in CRP 12 Months 15-20% Change in Uric Acid Levels 12 Months
- Secondary Outcome Measures
Name Time Method Quality of life outcome based on SF 36 questionnaire. 12 months To observe inflammatory and oxidative stress biomarkers. 12 months Observe inflammatory markers IL-1beta, NF-kappaB, Protein Bound Pentosidine, Beta2 Microglobulin, Indoxyl sulfate, Phenols, p-cresols, and guanadine metabolites from blood serum.
Trial Locations
- Locations (1)
Thomas Jefferson University
🇺🇸Philadelphia, Pennsylvania, United States