Observational Study of Kibow Biotics in Chronic Kidney Failure Patients

Completed

• Conditions: Chronic Kidney Failure
• Interventions: Dietary Supplement: Kibow Biotics/Renadyl

• Registration Number: NCT01450657
• 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 standardized care of treatment for their CKD stage 3 and stage 4 conditions.

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.

Study Timeline

• Study Start: 2011-07
• Study First Submitted: 2011-09-26
• Study First Submitted QC: 2011-10-10
• Study First Posted: 2011-10-12
• Primary Completion: 2012-09
• Study Completion: 2012-10
• Status Verified: 2017-08
• Last Update Submitted: 2017-08-15
• Last Update Posted: 2017-08-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 31

Inclusion Criteria

• Age 18 to 75 years
• CKD Stages 3 and 4 as documented by prior medical history
• Serum Creatinine >2.5 mg/dL
• Stable and on CKD status 3 and 4 at least for a year or more

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
• Any non-related medical, debilitating disease/disorder that would interfere with adherence to this study
• Currently on anticoagulant therapy

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Chronic Kidney Failure 3/4	Kibow Biotics/Renadyl	-

Primary Outcome Measures

Name	Time	Method
15-20% Changes in BUN.	Baseline, 1 month, 2 months, 3 months, 4 months, 6 months.
15-20% Change in Creatinine	Baseline, 1 month, 2 months, 3 months, 4 months, 6 months

Secondary Outcome Measures

Name	Time	Method
Quality of life outcome based on questionnaire.	Baseline, 1 month, 2 months, 3 months, 4 months, 6 months
To observe inflammatory and oxidative stress biomarkers.	Baseline, 1 month, 2 months, 3 months, 4 months, 6 months	Observe inflammatory and stress markers in metabolites from blood serum.
Observation and analysis of patient fecal matter.	Baseline, 1 month, 2 months, 3 months, 4 months, 6 months	Observation and analysis of patient fecal matter to determine bacterial flora levels that are present in the stool.

Trial Locations

Locations (1)

Thomas Jefferson University; 🇺🇸 Philadelphia, Pennsylvania, United States