Randomised clinical trial: the beneficial effects of VSL#3 in obese children with non‐alcoholic steatohepatitis
Open accessAbstract
Summary: Background: Gut microbiota modifiers may have beneficial effects of non‐alcoholic fatty liver disease (NAFLD) but randomised controlled trials (RCT) are lacking in children. Aim: To perform a double‐blind RCT of VSL#3 vs. placebo in obese children with biopsy‐proven NAFLD. Methods: Of 48 randomised children, 44 (22 VSL#3 and 22 placebo) completed the study. The main outcome was the change in fatty liver severity at 4 months as detected by ultrasonography. Secondary outcomes were the changes in triglycerides, insulin resistance as detected by the homoeostasis model assessment (HOMA), alanine transaminase (ALT), body mass index (BMI), glucagon‐like peptide 1 (GLP‐1) and activated GLP‐1 (aGLP‐1). Ordinal and linear models with cluster confidence intervals were used to evaluate the efficacy of VSL#3 vs. placebo at 4 months. Results: At baseline, moderate and severe NAFLD were present in 64% and 36% of PLA children and in 55% and 45% of VSL#3 children. The probability that children supplemented with VSL#3 had none, light, moderate or severe FL at the end of the study was 21%, 70%, 9% and 0% respectively with corresponding values of 0%, 7%, 76% and 17% for the placebo group (P < 0.001). No between‐group differences were detected in triglycerides, HOMA and ALT while BMI decreased and GLP‐1 and a GLP 1 increased in the VSL#3 group (P < 0.001 for all comparisons). Conclusions: A 4‐month supplement of VSL#3 significantly improves NAFLD in children. The VSL#3‐dependent GLP‐1 increase could be responsible for these beneficial effects. Trial identifier: NCT01650025 (www.clinicaltrial.gov)
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A randomized trial showed that 4-month VSL#3 supplementation improves NAFLD in children.
“Another randomized trial showed that 4-month supplementation with VSL#3 improves NAFLD in children122.”
From The gut microbiome and liver cancer: mechanisms and clinical translation (2017) · cites this paper as [122]
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- Authors
- Alisi, A., Bedogni, G., Baviera, G., Giorgio, V., Porro, E., Paris, C., Giammaria, P., Reali, L., Anania, F., & Nobili, V.
- Affiliations
- Bambino Gesù Children's Hospital (IT)
- Clinical Epidemiology Unit Liver Research Center Basovizza Trieste Italy
- Family paediatrician Rome Italy
- Emory University (US)
- Corresponding author
- Nobili, V.
- Venue
- Alimentary Pharmacology & Therapeutics
- Publisher
- Wiley
- Published
- 2014-04-16
- Volume
- 39
- Issue
- 11
- Pages
- 1276-1285
- ISSN
- 0269-2813 (ISSN-L)
- 1365-2036
- PMC
- PMC4046270
- OpenAlex
- W2069354135
- Cited by
- 471
- References
- 50
- Citations by year
- 2026: 21 · 2025: 35 · 2024: 41 · 2023: 42 · 2022: 41 · 2021: 48 · 2020: 43 · 2019: 49 · 2018: 39 · 2017: 42 · 2016: 36 · 2015: 24 · 2014: 10
- FWCI
- 28.21
- Type
- journal article
- Language
- en
- Open access
- green
- www.ncbi.nlm.nih.gov
- Locations
- Alimentary Pharmacology & Therapeutics (publishedVersion)
- PubMed (publishedVersion)
- PubMed Central (acceptedVersion)
- Archivio istituzionale della ricerca (Alma Mater Studiorum Università di Bologna) (submittedVersion)
- Funders
- U.S. Department of Veterans Affairs (I01 BX001746)
- National Institute of Diabetes and Digestive and Kidney Diseases (R56DK062092, R01DK062092, DK-062092)
- Topics
- Health Sciences › Medicine › Epidemiology › Liver Disease Diagnosis and Treatment
- 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, nonalcoholic steatohepatitis, non-alcoholic fatty liver disease, childhood obesity, gut microbiota modulation, prebiotic supplementation, glucagon-like peptide-1, insulin resistance, triglycerides, alanine aminotransferase, body mass index
- MeSH terms
- Alanine Transaminase, Biopsy, Child, Double-Blind Method, Fatty Liver, Female, Humans, Insulin Resistance, Male, Obesity, Severity of Illness Index, Ultrasonography, Body Mass Index, Treatment Outcome, Dietary Supplements, Probiotics, Glucagon-Like Peptide 1, Non-alcoholic Fatty Liver Disease
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