Observational Study of Kibow Biotics in Chronic Kidney Failure Patients on Dialysis
NCT01450709 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 30
Last updated 2019-08-20
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 dialysis along with standardized care of treatment.
Conditions
Interventions
- DIETARY_SUPPLEMENT
-
Kibow Biotics
6 month, double-blind, cross-over, wash-out, placebo controlled study in an outpatient setting. Each patient takes two capsules, three times a day (180 CFU/day).
Sponsors & Collaborators
-
State University of New York - Downstate Medical Center
collaborator OTHER -
Kibow Pharma
lead INDUSTRY
Principal Investigators
-
Subodh J Saggi, M.D., MPH · Downstate Medical Center
-
Mary Mallapallil, M.D. · Kings County Medical Center
-
Eli Friedman, M.D., MACP, FRCP · Downstate Medical Center
-
Gary Briefel, M.D. · Kings County Medical Center
Eligibility
- Min Age
- 18 Years
- Max Age
- 75 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2011-04-30
- Primary Completion
- 2012-09-30
- Completion
- 2012-10-31
Countries
- United States
Study Locations
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