Observational Study of Kibow Biotics in Chronic Kidney Failure Patients

Sponsor

Kibow Pharma (Industry)

Overall Status

Completed

CT.gov ID

NCT01450657

Collaborator

Thomas Jefferson University (Other)

Enrollment

Location

Duration (Months)

2.1

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Chronic Kidney Failure	Dietary Supplement: Kibow Biotics/Renadyl

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 Design

Study Type:

Observational

Actual Enrollment :

31 participants

Observational Model:

Cohort

Time Perspective:

Prospective

Official Title:

Observational Clinical Trials of Kibow Biotics (a Patented and Proprietary Probiotic Dietary Supplement) in Chronic Kidney Failure Patients, in Conjunction With Standardized Care of Treatment

Study Start Date :

Jul 1, 2011

Actual Primary Completion Date :

Sep 1, 2012

Actual Study Completion Date :

Oct 1, 2012

Arms and Interventions

Arm	Intervention/Treatment
Chronic Kidney Failure 3/4	Dietary Supplement: Kibow Biotics/Renadyl Month 1, one capsule three times daily (90 colony forming units); Month 2, two capsules three times daily (180 CFU's); Month 3 & 4, three capsules three times daily (270 CFU's). Months 5 & 6 are washout periods, in which the patient receives no product. All parameters are still monitored by the study site during months 5 & 6. All medical, physical, clinical, QOL and other parameters will be monitored as well. Other Names: Kibow Biotics

Arm

Intervention/Treatment

Chronic Kidney Failure 3/4

Dietary Supplement: Kibow Biotics/Renadyl

Month 1, one capsule three times daily (90 colony forming units); Month 2, two capsules three times daily (180 CFU's); Month 3 & 4, three capsules three times daily (270 CFU's). Months 5 & 6 are washout periods, in which the patient receives no product. All parameters are still monitored by the study site during months 5 & 6. All medical, physical, clinical, QOL and other parameters will be monitored as well.

Other Names:

Kibow Biotics

Outcome Measures

Primary Outcome Measures

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

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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 75 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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