Pilot study of probiotic dietary supplementation for promoting healthy kidney function in patients with chronic kidney disease.
BACKGROUND
Uremic syndrome consists of nitrogenous waste retention, deficiency in kidney-derived hormones, and reduced acid excretion, and, if untreated, may progress to coma and eventual death. Previous experience suggests that oral administration of a probiotic formulation of selected microbial strains may extend renoprotection via intraintestinal extraction of toxic waste solutes in patients with chronic kidney disease (CKD)stages 3 and 4. This report presents preliminary data from a pilot study.


METHODS
This was a 6-month prospective, randomized, double-blind, placebo-controlled crossover trial of a probiotic bacterial formulation conducted in four countries, at five institutions, on 46 outpatients with CKD stages 3 an nd 4: USA (n=10), Canada (n=113), Nigeria (n=115), and Argentina (n=8). Outcomes were compared using biochemical parameters:blood urea nitrogen (BUN), serum creatinine, and uric acid. General well-being was assessed as a secondary parameter by a quality of life (QQOL) questionnaire on a subjective scale of 1-10.


RESULTS
Oral ingestion of probiotics (90 billion colony forming units [CFUs]/day) was well tolerated and safe during the entire trial period at all sites. BUN levels decreased in 29 patients (63%, P<0.05), creatinine levels decreased in 20 patients (43%, no statistical significance), and uric acid levels decreased in 15 patients (33%, no statistical significance). Almost all subjects expressed a perceived substantial overall improvement in QOL (86%, P<0.05).


CONCLUSIONS
The main outcomes of this preliminary trial include a significant reduction of BUN, enhanced well-being, and absence of serious adverse effects, thus supporting the use of the chosen probiotic formulation for bowel-based toxic solute extraction. QOL and BUN levels showed statistically significant differences in outcome (P<0.05) between placebo and probiotic treatment periods at all four sites (46 patients). A major limitation of this trial is the small sample size nd elated inconsistencies.
Ranganathan
Natarajan
N
Kibow Biotech, Inc., 4629 West Chester Pike, Newtown Square, PA 19073, USA. rangan@kibowbiotech.com
Ranganathan
Pari
P
Friedman
Eli A
EA
Joseph
Anthony
A
Delano
Barbara
B
Goldfarb
David S
DS
Tam
Paul
P
Rao
A Venketeshwer
AV
Anteyi
Emmanuel
E
Musso
Carlos Guido
CG
D000328:Adult; D000368:Aged; D001118:Argentina; D002170:Canada; D003404:Creatinine / Q000032:analysis; D019587:Dietary Supplements / Q000592:standards; D018450:Disease Progression; D004311:Double-Blind Method; D005260:Female; D006801:Humans; D007677:Kidney Function Tests; D008297:Male; D008875:Middle Aged; D009549:Nigeria; D010865:Pilot Projects; D019936:Probiotics / Q000493:pharmacokinetics; D020011:Protective Agents / Q000493:pharmacokinetics; D011788:Quality of Life; D051436:Renal Insufficiency, Chronic / Q000097:blood / Q000150:complications / Q000503:physiopathology / Q000628:therapy*; D057566:Self Report; D016896:Treatment Outcome; D014481:United States; D014511:Uremia / Q000097:blood / Q000209:etiology / Q000503:physiopathology / Q000517:prevention & control*; D014527:Uric Acid / Q000032:analysis; D055815:Young Adult
D020011:Protective Agents; D014527:Uric Acid; D003404:Creatinine