Dose Escalation, Safety and Impact of a Strain-Specific Probiotic (RenadylÂ™) on Stages III and IV Chronic Kidney Disease Patients
- *Corresponding Author:
- Natarajan Ranganathan
Kibow Biotech, Inc. 4781 West Chester Pike
Newtown Square, PA 19073, USA
E-mail: [email protected]
Received Date: September 20, 2013; Accepted Date: October 25, 2013; Published Date: October 29, 2013
Citation: Ranganathan N, Pechenyak B, Vyas U, Ranganathan P, DeLoach S, et al. (2013) Dose Escalation, Safety and Impact of a Strain-Specific Probiotic (Renadyl™) on Stages III and IV Chronic Kidney Disease Patients. J Nephrol Ther 3:141. doi:10.4172/2161-0959.1000141
Copyright: © 2013 Ranganathan N, et al. This is an open-access article distributed under the terms of the Creative Commons Attribution License, which permits unrestricted use, distribution, and reproduction in any medium, provided the original author and source are credited.
The primary goal of the open label study of Renadyl™ in stage 3 and 4 chronic kidney disease patients was to confirm the safety and tolerability of several doses of Renadyl™ (90, 180, 270 billion colony forming units). Secondary goals were to quantify quality of life improvement, to confirm efficacy in reducing commonly known uremic toxins, and to investigate the effects on several biomarkers of inflammation and oxidative stress. Participants underwent physical examinations and venous blood testing, and completed quality of life questionnaires. Data were analyzed with SAS V9.2. Of 31 subjects, 28 (90%) completed the study (2 lost to follow-up). The primary goal was met, as no significant adverse events were noted during the dose escalation phase. All patients tolerated the maximum dose (note: 1 subject reported nausea upon initial use). The escalation efficacy was shown in statistically significant changes of serum creatinine (months 2 to 6: -0.23 mg/dL, p<0.05), C-reactive protein (months 2 to 6: -0.28 mg/L, p<0.05), and hemoglobin (base to month 6: 0.35 mg/dL, p<0.01, months 1 to 6: 0.46 mg/dL, p<0.001, months 2 to 6: 0.58 mg/dL, p<0.0001). Trends, but not statistical significance, were noted in blood urea nitrogen (base to month 4: -3.56 mg/dL, p<0.09; months 1 to 4: -3.81 mg/dL, p<0.07). The secondary goal was also met, as QOL measure of physical functioning improved (base to month 6, p<0.05) and a strong trend in reduction of pain was observed (base to month 6, p<0.08).