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Observational Study of Kibow Biotics in Chronic Kidney Failure Patients

NCT01450657 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 31

Last updated 2017-08-18

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 standardized care of treatment for their CKD stage 3 and stage 4 conditions.

Conditions

  • Chronic Kidney Failure

Interventions

DIETARY_SUPPLEMENT

Kibow Biotics/Renadyl

Month 1, one capsule three times daily (90 colony forming units); Month 2, two capsules three times daily (180 CFU's); Month 3 \& 4, three capsules three times daily (270 CFU's). Months 5 \& 6 are washout periods, in which the patient receives no product. All parameters are still monitored by the study site during months 5 \& 6. All medical, physical, clinical, QOL and other parameters will be monitored as well.

Sponsors & Collaborators

  • Thomas Jefferson University

    collaborator OTHER

  • Kibow Pharma

    lead INDUSTRY

Principal Investigators

  • Stephanie DeLoach, M.D. · Thomas Jefferson University, Philadelphia, PA

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2011-07-31
Primary Completion
2012-09-30
Completion
2012-10-31

Countries

  • United States

Study Locations

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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 NCT01450657 on ClinicalTrials.gov