Pilot-Scale Clinical Trials of Kibow Biotics® in Chronic Kidney Failure (Probiotics)

August 16, 2019 updated by: Kibow Pharma

Pilot-Scale Clinical Trials of Kibow Biotics® (a Patented and Proprietary Probiotic Formulation) in Chronic Kidney Failure

The bowel can serve as a complement to the kidneys' excretory function

A specifically formulated probiotic product comprised of defined and tested microbial strains may afford renoprotection in what has been called "enteric dialysis"® Confirm the alleviation of uremic syndrome hypothesis Determine the outcome of probiotics treatment Confirm U.S. FDA's Generally Recognized As Safe (GRAS) status - if needed

Study Overview

Status

Completed

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.

Following exploratory testing of orally administered probiotic bacteria in rats and minipigs with surgically induced chronic kidney disease (CKD), a trial is now in progress to determine whether daily treatment with gastrointestinal (GI) probiotic bacteria will delay the onset of and/or improve established signs and symptoms of human CKD.

To assess the potential benefit in devising a gut-based probiotic formulation (Kibow Biotics®) as a dieatary supplement - Over The Counter (OTC)product in CKD applications.

Extensive in vitro R&D investigations in Kibow's laboratories

Simulated Human Intestinal Microbial Ecosystem (SHIME, Ghent University, Belgium) utilized in a computer-controlled in vitro system validated the concept that the chosen microbial formulation would metabolize and reduce concentration of nitrogenous components including urea, creatinine, and uric acid. Bacterial strains studied were 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® on clinically manifested renal failure in uremic cats and dogs of both genders and varying body weights. Based on positive results, this formulation, marketed and distributed as AzodylTM, is currently licensed for veterinary applications to Vetoquinol USA

Study Type

Observational

Enrollment (Actual)

180

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
    • New York
      • Brooklyn, New York, United States, 11203
        • Downstate Medical Center,HSCB, State University of New York
      • Brooklyn, New York, United States, 11203
        • SUNY DownState Medical Center-Renakl Division

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

18 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

Out patient Hospital setting

Description

Inclusion Criteria:

  • CKD patients Stage III and IV
  • 18 to 75 years old, able and willing to give an informed consent
  • Baseline serum creatinine > 2.5 mg/dL

Exclusion Criteria:

  • Women who are pregnant or nursing
  • Patients who are on antibiotic treatment at the time of screening will be excluded from the study (Patients who have received antibiotics should have stopped them for at least 14 days prior to screening)
  • Patients who do not agree to sign the informed consent form
  • Active dependency on drugs or alcohol
  • Patients with documented Human Immunodeficiency Virus (HIV) infection/ Acquired Immunodeficiency Syndrome (AIDS)/Liver Disease
  • Any medical, psychiatric, debilitating disease/disorder or social condition that in the judgment of the investigator would interfere with or serve as a contraindication to adherence to the study protocol or ability to give informed consent, or affect the overall prognosis of the patient
  • Patients who are on coumadin 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

Cohorts and Interventions

Group / Cohort
HSCB, Brooklyn, NY
State University of New York Brooklyn, NY 11203
2. Nephrology Associates,
Scarborough, ON CANADA, LI H IC5
3.New York Harbor VA Medical Center
NYU School of Medicine New York, NY.10010
4.Hospital Juarez De Mexico
Madero, Mexico, D.FC.P. 07760
5. Hospital Italiano de Buenos Aires
Buenos Aires, Argentina.
6. National Hospital
Abuja, Nigeria

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
PRIMARY: Changes in blood chemistry - BUN, Creatinine and Uric acid
Time Frame: six months
six months
Changes in BUN, Creatinine and uric acid levels
Time Frame: six months
six months

Collaborators and Investigators

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

Sponsor

Kibow Pharma

Investigators

  • Study Chair: Eli A Friedman, MD, Downstate Medical Center - State University of New York, Brooklyn, NY

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

August 1, 2007

Primary Completion (Actual)

July 1, 2009

Study Completion (Actual)

August 1, 2009

Study Registration Dates

First Submitted

September 25, 2008

First Submitted That Met QC Criteria

September 25, 2008

First Posted (Estimate)

September 26, 2008

Study Record Updates

Last Update Posted (Actual)

August 20, 2019

Last Update Submitted That Met QC Criteria

August 16, 2019

Last Verified

August 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • KIB001

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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