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. 2024 Feb 5;13(3):919.
doi: 10.3390/jcm13030919.

Efficacy and Safety of a Probiotic Containing Saccharomyces boulardii CNCM I-745 in the Treatment of Small Intestinal Bacterial Overgrowth in Decompensated Cirrhosis: Randomized, Placebo-Controlled Study

Irina Efremova  1 , Roman Maslennikov  1   2 , Maria Zharkova  1 , Elena Poluektova  1   2 , Nona Benuni  1 , Aleksandr Kotusov  1 , Tatyana Demina  1 , Aleksandra Ivleva  1 , Farida Adzhieva  1 , Taisiya Krylova  1 , Vladimir Ivashkin  1
Affiliations

Efficacy and Safety of a Probiotic Containing Saccharomyces boulardii CNCM I-745 in the Treatment of Small Intestinal Bacterial Overgrowth in Decompensated Cirrhosis: Randomized, Placebo-Controlled Study

Irina Efremova et al. J Clin Med. .

Abstract

(1) Background: The aim was to evaluate the effectiveness of the probiotic containing Saccharomyces boulardii in the treatment of small intestinal bacterial overgrowth (SIBO) in patients with decompensated cirrhosis. (2) Methods: This was a blinded, randomized, placebo-controlled study. (3) Results: After 3 months of treatment, SIBO was absent in 80.0% of patients in the probiotic group and in 23.1% of patients in the placebo group (p = 0.002). The patients with eliminated SIBO had decreased frequency of ascites and hepatic encephalopathy, the increased platelets and albumin levels, the decreased blood levels of total bilirubin, biomarkers of bacterial translocation (lipopolysaccharide [LPS]) and systemic inflammation (C-reactive protein), and positive changes in markers of hyperdynamic circulation compared with the state at inclusion. There were no significant changes in the claudin 3 level (the intestinal barrier biomarker) in these patients. No significant changes were observed in the group of patients with persistent SIBO. The serum level of nitrate (endothelial dysfunction biomarker) was lower in patients with eradicated SIBO than in patients with persistent SIBO. One (5.3%) patient with eradicated SIBO and six (42.9%) patients with persistent SIBO died within the first year of follow-up (p = 0.007). (4) Conclusions: SIBO eradication was an independent predictor of a favorable prognosis during the first year of follow-up.

Keywords: endotoxemia; gut–heart axis; gut–liver axis; hemodynamics; leaky gut; liver; microbiota; probiotics; vasodilatation.

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Conflict of interest statement

The sponsor did not participate in the development of the design and did not influence the course of the study, the processing of the results and the decision to publish.

Figures

Figure 1
Figure 1
CONSORT 2010 flow diagram.
Figure 2
Figure 2
Efficacy of probiotic and placebo in treating small intestinal bacterial overgrowth (SIBO) in patients with decompensated cirrhosis.
Figure 3
Figure 3
Survival curves of included patients with decompensated cirrhosis: (a) in the probiotic and placebo groups throughout the 2-year follow-up period; (b) in the probiotic and placebo groups during the first year of follow-up; (c) in the probiotic and placebo groups during the second year of follow-up; (d) in the groups of eradicated and persistent SIBO throughout the 2-year follow-up; (e) in the group of eradicated and persistent SIBO groups during the first year of follow-up; and (f) in groups of eradicated and persistent SIBO during the second year of follow-up.
See this image and copyright information in PMC

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