Observational Study of Kibow Biotics in Dialysis Patients

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. 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.

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

Conditions
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Chronic Kidney Failure

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>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Quality of life outcome based on SF 36 questionnaire. |  | 12 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. | 12 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