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

Study Overview
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Brief Summary
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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
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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.

Official Title
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Observational Clinical Trials of Kibow Biotics® (a Patented and Proprietary Probiotic Formulation) in Dialysis Patients, in Conjunction With Standardized Care of Treatment

Conditions
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Chronic Kidney Disease

Intervention / Treatment
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* Dietary Supplement: Kibow Biotics


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Dialysis patients<br> | Dietary Supplement: Kibow Biotics<br>* 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).<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 15-20% Changes in BUN. |  | 6 months | 
| 15-20% Changes in Creatinine |  | 6 months | 
| 15-20% Changes in CRP |  | 6 months | 
| 15-20% Changes in Uric Acid Levels |  | 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Quality of life outcome based on SF 36 questionnaire. |  | 6 months | 
| To observe inflammatory and oxidative stress biomarkers. | Observe inflammatory markers IL-1beta, NF-kappaB, Protein Bound Pentosidine, Beta2 Microglobulin, Indoxyl sulfate, Phenols, p-cresols, and guanadine metabolites from blood serum. | 6 months | 
| Observation and analysis of patient fecal matter. | Observation and analysis of patient fecal matter to determine bacterial flora levels that are present in the stool. | 6 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Probiotics, Kibow Biotics, Dialysis, Gut based uremic toxin removal