Probiotic dietary supplementation in patients with stage 3 and 4 chronic kidney disease: a 6-month pilot scale trial in Canada

ABSTRACT

Aim: This was a pilot clinical trial to assess biochemical and clinical effects of an oral probiotic dietary supplement in chronic kidney disease (CKD) patients (stages 3 and 4).

Methods: A prospective, randomized, double-blind, crossover, placebo-controlled, 6-month trial of probiotic bacteria was conducted in 16 outpatients in Ontario, Canada. Primary endpoints included effect on hematologic, biochemical, and fecal variables, and on general well-being as assessed by quality of life (QOL). These outcomes were evaluated from biochemical parameters, mainly blood urea nitrogen (BUN), creatinine, uric acid, and C-reactive protein (CRP) as a general inflammatory marker. QOL was assessed on a subjective scale of 1 to 10 as the secondary parameter.

Trial registration: This pilot study forms part of registered trial NCT00760162.

Results: A total of 13 patients completed the study. Three patients dropped out: one was the receiver of a transplant. The second dropped out for unknown reasons and the third died of myocardial infarction (unrelated to probiotic bacteria or the protocol). Among the 13 patients who completed the trial, the mean change in BUN concentration during the probiotic treatment period (−2.93 mmol/L) differed significantly (p = 0.002) from the mean change in BUN concentration during the placebo period (4.52 mmol/L). In addition, the mean changes in uric acid concentration were moderate during the KB period (24.70 μmol/L) versus during the placebo period (50.62 μmol/L, p = 0.050), and the changes in serum creatinine concentration were insignificant. Neither gastrointestinal nor infectious complications were noted in any subject with improved QOL.

Conclusion: Orally administered probiotic bacteria selected to metabolize nitrogenous wastes may be tolerated for as long as 6 months. A major limitation of this trial is its small size that may have precluded detection of changes in other biochemical or hematologic parameters that would be evident in larger cohorts. Extension of the evaluation of this probiotic bacterial mixture will include a dose escalation trial in a similar prospective, placebo-controlled, and double-blind study site.

Keywords: :

• Disease progression
• Healthy kidney
• Probiotics
• Uremic syndrome

Transparency

Declaration of funding

Funding for this Canadian study was provided by Gelda Scientific, Inc, Mississauga, Ontario, Canada (in exchange for rights to distribute the product in Canada). Kibow Biotech has funded the publication of this article.

Declaration of financial/other relationships

N.R. has disclosed that he is the Senior Vice-President of research and development at Kibow Biotech, Inc. P.R. has disclosed that she is the Vice-President for clinical and regulatory affairs, Kibow Biotech, Inc. N.R. and P.R. have both disclosed that they hold a substantial combined business interest in Kibow Biotech, Inc. R.D. has disclosed that he is an employee of Kibow Biotech, Inc. E.A.F. has disclosed that he serves, without compensation, as Chair of Kibow Biotech's Scientific Advisory Board, and that his Renal Division currently receives research funding for a clinical trial of Kibow Probiotics. P.T. and V.R. have disclosed that they have not received any compensation from Kibow Biotech for conducting this pilot-scale clinical study.

All peer reviewers receive honoraria from CMRO for their review work. Peer Reviewer 1 has disclosed that he/she is a scientific consultant on clinical trials for Jamieson Laboratories Inc. Peer Reviewer 2 has disclosed that he/she has no relevant financial relationships.

Acknowledgments

The authors thank Bohdan Pechenyak, a part-time employee of Kibow Biotech (and also currently a graduate student at Temple University, Philadelphia), for assistance in the initial drafting of this paper. The authors also acknowledge the help and continued interaction with Dione Rochester, monitor for this study at the Corporate Medical Center, Scarborough, ON, Canada.

Notes

* Kibow Biotics and ‘Bowel for Kidney’ are registered trademarks of Kibow Biotech, PA, USA