Status:
COMPLETED
Pilot-Scale Clinical Trials of Kibow Biotics® in Chronic Kidney Failure
Lead Sponsor:
Kibow Pharma
Conditions:
Chronic Kidney Failure
Eligibility:
All Genders
18-75 years
Brief Summary
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 ...
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 ...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
August 1 2007
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
August 1 2009
Estimated Enrollment :
180 Patients enrolled
Trial Details
Trial ID
NCT00760162
Start Date
August 1 2007
End Date
August 1 2009
Last Update
August 20 2019
Active Locations (2)
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1
Downstate Medical Center,HSCB, State University of New York
Brooklyn, New York, United States, 11203
2
SUNY DownState Medical Center-Renakl Division
Brooklyn, New York, United States, 11203