Chronic Kidney Failure
Conditions
Keywords
Probiotics, Kibow Biotics, Dialysis, Gut based uremic toxin removal
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.
Interventions
DIETARY_SUPPLEMENTKibow Biotics
Month 1, one capsule three times daily (90 Colony forming units); Month 2, two capsules three times daily (180 CFU's); Month 3, three capsules three times daily (270 CFU's). Continued on tolerated maintenance dosage for an additional 6 months. Once tolerated dosage is identified the patient will be continued on that maintenance dosage for an additional 6 months. All medical, physical, clinical, QOL and other parameters will be monitored as well.
Sponsors
Thomas Jefferson University
Kibow Pharma
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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. |
Countries
United States
Outcome results
None listed