Observational Study of Kibow Biotics in Chronic Kidney Failure Patients on Dialysis

NCT01450709 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 30

Last updated 2019-08-20

No results posted yet for this study

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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Entities

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01450709 on ClinicalTrials.gov