Pilot-Scale Clinical Trials of Kibow Biotics® in Chronic Kidney Failure
Completed
Conditions studied: Chronic Kidney Failure
In brief
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
Key facts
- Study ID
- NCT00760162
- Run by
- Kibow Pharma
- People needed
- 180
- Starts
- 2007-08-01
- Expected to finish
- 2009-08-01
- Last updated by the study team
- 2019-08-20
Who can join
Age: 18 and older, up to 75. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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
You may not qualify if…
- 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
Where it is running
- Downstate Medical Center,HSCB, State University of New York — Brooklyn, New York, United States
- SUNY DownState Medical Center-Renakl Division — Brooklyn, New York, United States
Full record on ClinicalTrials.gov
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