Observational Study of Kibow Biotics in Chronic Kidney Failure Patients

August 15, 2017 updated by: Kibow Pharma

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

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.

Study Overview

Status

Completed

Conditions

Intervention / 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.

Study Type

Observational

Enrollment (Actual)

31

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Pennsylvania
      • Philadelphia, Pennsylvania, United States, 19107
        • Thomas Jefferson University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years to 73 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

Outpatient hospital setting.

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
15-20% Changes in BUN.
Time Frame: Baseline, 1 month, 2 months, 3 months, 4 months, 6 months.
Baseline, 1 month, 2 months, 3 months, 4 months, 6 months.
15-20% Change in Creatinine
Time Frame: Baseline, 1 month, 2 months, 3 months, 4 months, 6 months
Baseline, 1 month, 2 months, 3 months, 4 months, 6 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Quality of life outcome based on questionnaire.
Time Frame: Baseline, 1 month, 2 months, 3 months, 4 months, 6 months
Baseline, 1 month, 2 months, 3 months, 4 months, 6 months
To observe inflammatory and oxidative stress biomarkers.
Time Frame: Baseline, 1 month, 2 months, 3 months, 4 months, 6 months
Observe inflammatory and stress markers in metabolites from blood serum.
Baseline, 1 month, 2 months, 3 months, 4 months, 6 months
Observation and analysis of patient fecal matter.
Time Frame: 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.
Baseline, 1 month, 2 months, 3 months, 4 months, 6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Kibow Pharma

Collaborators

Thomas Jefferson University

Investigators

  • Principal Investigator: Stephanie DeLoach, M.D., Thomas Jefferson University, Philadelphia, PA

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 2011

Primary Completion (Actual)

September 1, 2012

Study Completion (Actual)

October 1, 2012

Study Registration Dates

First Submitted

September 26, 2011

First Submitted That Met QC Criteria

October 10, 2011

First Posted (Estimate)

October 12, 2011

Study Record Updates

Last Update Posted (Actual)

August 18, 2017

Last Update Submitted That Met QC Criteria

August 15, 2017

Last Verified

August 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • KIB002

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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