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Randomized Controlled Trial
. 2022 Apr 14;14(8):1637.
doi: 10.3390/nu14081637.

Probiotics-Supplemented Low-Protein Diet for Microbiota Modulation in Patients with Advanced Chronic Kidney Disease (ProLowCKD): Results from a Placebo-Controlled Randomized Trial

Andreana De Mauri  1 , Deborah Carrera  2 , Marco Bagnati  3 , Roberta Rolla  3   4 , Matteo Vidali  5 , Doriana Chiarinotti  1 , Marco Pane  6 , Angela Amoruso  6 , Mario Del Piano  7
Affiliations
Randomized Controlled Trial

Probiotics-Supplemented Low-Protein Diet for Microbiota Modulation in Patients with Advanced Chronic Kidney Disease (ProLowCKD): Results from a Placebo-Controlled Randomized Trial

Andreana De Mauri et al. Nutrients. .

Abstract

The probiotics-supplemented low-protein diet in chronic kidney disease (ProLowCKD) was a single-centre, double-blind, placebo-controlled, randomised trial that was conducted to investigate whether the association between a low protein diet (LPD) and a new formulation of probiotics (Bifidobacterium longum and Lactobacillus reuteri) was effective at reducing traditional uremic, microbiota-derived, and proatherogenic toxins in sixty patients affected by advanced CKD. After 2 months of a LPD-a reduction in blood urea nitrogen (52 ± 17 vs. 46 ± 15 mg/dL, p = 0.003), total cholesterol (185 ± 41 vs. 171 ± 34 mg/dL, p = 0.001), and triglycerides (194 ± 148 vs. 161 ± 70 mg/dL, p = 0.03) was observed; 57 subjects were then randomized to receive probiotics or a placebo for the subsequent 3 months. A total of 27 patients in the placebo group showed increased serum values of total cholesterol (169 ± 36 vs. 185 ± 40 mg/dL, p = 0.01), LDL cholesterol (169 ± 36 vs. 185 ± 40 mg/dL, p = 0.02), lipoprotein-associated phospholipase A2 (155.4 ± 39.3 vs. 167.5 ± 51.4 nmol/mL/min, p = 0.006), and indoxyl-sulphate (30.1 ± 17.6 vs. 34.5 ± 20.2 μM, p = 0.026), while the 24 subjects in the probiotics group showed a trend in the reduction of microbiota toxins. A reduction of antihypertensive and diuretic medications was possible in the probiotics group. This study shows that associating probiotics to LPD may have an additional beneficial effect on the control and modulation of microbiota-derived and proatherogenic toxins in CKD patients.

Keywords: chronic kidney disease; ecologic therapy; green nephrology; gut microbiota; low protein diet; microbial uremic toxins; probiotics.

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Conflict of interest statement

Mario Del Piano was the Head of Clinical Research of Probiotical S.p.A.; Marco Pane and Angela Amoruso are employees of Probiotical S.p.A.

Figures

Figure 1
Figure 1
Flow chart of patient evaluations.
Figure 2
Figure 2
Dialysis-free survival in the probiotics group (continuous line) and placebo group (dashed line) (log rank p = 0.080).
Figure 3
Figure 3
Cardiovascular event-free survival in the probiotics group (continuous line) and placebo group (dashed line) (log rank p = 0.5).
See this image and copyright information in PMC

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