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

Nutrients
April 14, 2022
Andreana De Mauri et al. (9 authors)
Journal ArticleRandomized Controlled TrialHuman StudyClinical
Study Details

Study Goal

The researchers aimed to determine if combining a low-protein diet (LPD) with probiotics (Bifidobacterium longum and Lactobacillus reuteri) could reduce uremic, microbiota-derived, and proatherogenic toxins in advanced CKD patients.

Results Summary

The study found that LPD alone reduced blood urea nitrogen, total cholesterol, and triglycerides after 2 months. Probiotics supplementation further showed a trend in reducing microbiota-derived toxins and allowed a reduction in antihypertensive and diuretic medications, while the placebo group exhibited increased serum toxins.

Population

Sixty patients with advanced chronic kidney disease (CKD).

Effective Dosage

Not specified

Duration

2 months of LPD, followed by 3 months of probiotics or placebo.

Interactions

None mentioned

Extracted Claims (10)
InterventionDirectionEndpointPopulationDosageImpactClaim #
low protein diet (LPD)
decrease
blood urea nitrogen
sixty patients affected by advanced CKD
52 ± 17 vs. 46 ± 15 mg/dL
a reduction in
#1
low protein diet (LPD)
decrease
total cholesterol
sixty patients affected by advanced CKD
185 ± 41 vs. 171 ± 34 mg/dL
a reduction in
#2
low protein diet (LPD)
decrease
triglycerides
sixty patients affected by advanced CKD
194 ± 148 vs. 161 ± 70 mg/dL
a reduction in
#3
placebo
increase
total cholesterol
27 patients in the placebo group
169 ± 36 vs. 185 ± 40 mg/dL
showed increased serum values of
#4
placebo
increase
LDL cholesterol
27 patients in the placebo group
169 ± 36 vs. 185 ± 40 mg/dL
showed increased serum values of
#5
placebo
increase
lipoprotein-associated phospholipase A2
27 patients in the placebo group
155.4 ± 39.3 vs. 167.5 ± 51.4 nmol/mL/min
showed increased serum values of
#6
placebo
increase
indoxyl-sulphate
27 patients in the placebo group
30.1 ± 17.6 vs. 34.5 ± 20.2 μM
showed increased serum values of
#7
probiotics (Bifidobacterium longum and Lactobacillus reuteri)
decrease
microbiota toxins
24 subjects in the probiotics group
-
showed a trend in the reduction of
#8
probiotics (Bifidobacterium longum and Lactobacillus reuteri)
decrease
antihypertensive and diuretic medications
probiotics group
-
A reduction of
#9
associating probiotics to LPD
decrease
microbiota-derived and proatherogenic toxins
CKD patients
-
may have an additional beneficial effect on the control and modulation of
#10
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.

Medical Subject Headings (MeSH)
Cholesterol, LDLDiet, Protein-RestrictedDouble-Blind MethodFemaleGastrointestinal MicrobiomeHumansMaleMicrobiotaProbioticsRenal Insufficiency, ChronicToxins, Biological
Study Links
Quality Scores
SafetyNot Assessed
Efficacy75/10
Quality85/10
Citation Metrics
Total Citations31
Citations/Year10.3
Relative Citation Ratio4.59
NIH Percentile92%
Research Impact Scores
APT Score0.75
Weight Score2.98
Normalized Score0.67
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