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Probiotic VSL#3 Reduces Liver Disease Severity and Hospitalization in Patients With Cirrhosis: A Randomized, Controlled Trial
Abstract
Background & aims Little is known about whether probiotics can affect outcomes of patients with cirrhosis and hepatic encephalopathy (HE). We assessed the efficacy of a probiotic preparation in preventing the recurrence of HE (primary outcome) and reducing the number of hospitalizations and severity of liver disease in patients with cirrhosis.Methods We performed a double-blind trial at a tertiary care hospital in India. Patients with cirrhosis who had recovered from an episode of HE during the previous month were assigned randomly (using computer-generated allocation) to groups given a probiotic preparation (VSL#3, 9 × 10(11) bacteria; CD Pharma India Private Limited, New Delhi, India) (n = 66) or placebo (n = 64) daily for 6 months.Results There was a trend toward a reduction in the development of breakthrough HE among patients receiving the probiotic (34.8% in the probiotic group vs 51.6% in the placebo group; hazard ratio [HR], 0.65; 95% confidence interval [CI], 0.38-1.11; P = .12). Fewer patients in the probiotic group were hospitalized for HE (19.7% vs 42.2%, respectively; HR, 0.45; 95% CI, 0.23-0.87; P = .02) or for complications of cirrhosis (24.2%) than in the placebo group (45.3%) (HR, 0.52; 95% CI, 0.28-0.95; P = .034). Child-Turcotte-Pugh and model for end-stage liver disease scores improved significantly from baseline to 6 months in the probiotic group, but not in the placebo group. There were no adverse events related to VSL#3.Conclusions Over a 6-month period, daily intake of VSL#3 significantly reduced the risk of hospitalization for HE, as well as Child-Turcotte-Pugh and model for end-stage liver disease scores, in patients with cirrhosis. ClinicalTrials.gov number: NCT01110447.
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“A double-blind trial showed that daily intake of VSL#3 reduced the risk of hospitalization for hepatic encephalopathy, as well as Child–Turcotte–Pugh and model for end-stage liver disease (MELD) scores, in patients with cirrhosis121.”
From The gut microbiome and liver cancer: mechanisms and clinical translation (2017) · cites this paper as [121]
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Metadata
- Authors
- Dhiman, R. K., Rana, B., Agrawal, S., Garg, A., Chopra, M., Thumburu, K. K., Khattri, A., Malhotra, S., Duseja, A., & Chawla, Y. K.
- Affiliations
- Post Graduate Institute of Medical Education and Research (IN)
- Corresponding author
- Dhiman, Radha K.
- ORCID
- Venue
- Gastroenterology
- Publisher
- Elsevier BV
- Published
- 2014-12
- Volume
- 147
- Issue
- 6
- Pages
- 1327-1337.e3
- ISSN
- 0016-5085 (ISSN-L)
- OpenAlex
- W2170666048
- Cited by
- 339
- References
- 39
- Citations by year
- 2026: 12 · 2025: 15 · 2024: 28 · 2023: 37 · 2022: 26 · 2021: 47 · 2020: 33 · 2019: 31 · 2018: 33 · 2017: 30 · 2016: 25 · 2015: 20 · 2014: 2
- FWCI
- 14.38
- Type
- journal article
- Language
- en
- Open access
- closed
- Locations
- Gastroenterology (publishedVersion)
- PubMed (publishedVersion)
- Topics
- Health Sciences › Medicine › Hepatology › Liver Disease and Transplantation
- Life Sciences › Agricultural and Biological Sciences › Food Science › Probiotics and Fermented Foods
- Life Sciences › Biochemistry, Genetics and Molecular Biology › Molecular Biology › Gut microbiota and health
- Keywords
- VSL#3, probiotics, liver cirrhosis, hepatic encephalopathy, hospitalization, Child-Pugh score, MELD score, liver disease severity, cirrhosis complications
- MeSH terms
- Double-Blind Method, Female, Hepatic Encephalopathy, Hospitalization, Humans, Liver Cirrhosis, Male, Middle Aged, Quality of Life, Recurrence, Severity of Illness Index, Biomarkers, Treatment Outcome, Hospital Mortality, Probiotics, Tertiary Care Centers, Microbiota
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