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Observational Study of Kibow Biotics in Dialysis Patients

NCT01450670 · 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

  • Chronic Kidney Failure

Interventions

DIETARY_SUPPLEMENT

Kibow Biotics

Month 1, one capsule three times daily (90 Colony forming units); Month 2, two capsules three times daily (180 CFU's); Month 3, three capsules three times daily (270 CFU's). Continued on tolerated maintenance dosage for an additional 6 months. Once tolerated dosage is identified the patient will be continued on that maintenance dosage for an additional 6 months. 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
2011-05-31
Primary Completion
2012-06-30
Completion
2012-07-31

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 NCT01450670 on ClinicalTrials.gov