Evidence map›Paper›PMID 24738701›Full record

Trial reportAlimentary pharmacology & therapeutics2014

Randomised clinical trial: The beneficial effects of VSL#3 in obese children with non-alcoholic steatohepatitis.

A Alisi, G Bedogni, G Baviera, V Giorgio, E Porro, C Paris, P Giammaria, L Reali, F Anania, V Nobili

4 registry-linked trialsOpen access · bronzeAbstract readRandomized Controlled Trial
PubMed Full text at PMC Publisher
In one paragraph

Trial report in Alimentary pharmacology & therapeutics, 2014. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to 4 registered trials, which are not on this map. Cited by 228 papers, 23 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
228citing papers in PubMed, 23 pooled it
24.5field-weighted citation impact, top 1% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

NCT01650025 nacompletednot on this map

Effects of the Probiotic Preparation VSL#3 on the Metabolic, Endocrine, Lipidomic and Inflammatory Parameters as Well as Variation of the Microbiota in Pediatric Patients With Body Mass Index >90°

TypeinterventionalSponsorBambino Gesù Hospital and Research InstituteRan2012 to 2013Enrolled48ConditionsObesityArmsVSL#3 active probiotic, VSL#3 placebo
NCT03115385 naterminatednot on this mapstarted 2015, after this paper: background citation

Probiotics and the Gut Microbiome in Obese Hispanic Youth

TypeinterventionalSponsorUniversity of Southern CaliforniaRan2015 to 2016Enrolled22ConditionsObesity, Abdominal, AdiposityArmsVSL#3, Placebo
NCT04671186 nacompletednot on this mapstarted 2020, after this paper: background citation

Role of Probiotics in Treatment of Pediatric Nonalcoholic Fatty Liver Disease (NAFLD) Patients by Assessing With Fibroscan

TypeinterventionalSponsorNorthwell HealthRan2020 to 2023Enrolled47ConditionsNon-Alcoholic Fatty Liver DiseaseArmsCulturelle (Lactobacillus rhamnosus strain GG), Placebo
NCT06491342 nacompletednot on this mapstarted 2024, after this paper: background citation

Probiotic supplement versus placebo for decrease steatosis in metabolic dysfunction-associated steatotic liver disease (masld): a multicenter, randomized, double-blind, placebo-controlled trial

TypeinterventionalSponsorPhramongkutklao College of Medicine and HospitalRan2024 to 2025Enrolled90ConditionsFatty Liver, NonalcoholicArmsProbiotic, Placebo
3 · Its place in the literature

Who cites it

228 citing papers in PubMed, 23 syntheses or guidelines pooled it, 451 citations in OpenAlex.

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  12. Effect of Probiotics Therapy on Nonalcoholic Fatty Liver Disease.Computational and mathematical methods in medicine · 2022
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  16. THE THERAPEUTIC IMPACT OF PROBIOTICS ON NONALCOHOLIC FATTY LIVER DISEASE IN PEDIATRICS: A SYSTEMATIC REVIEW.Revista paulista de pediatria : orgao oficial da Sociedade de Pediatria de Sao Paulo · 2021
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168 more citing papers are in PubMed but not listed here.

4 · The record

Corrections and comments

5 · Who and what money

Authors and funding

10 authors at 4 institutions in 2 countries.

A AlisiHepato-Metabolic Disease Unit and Liver Research Unit, "Bambino Gesù" Children's Hospital, IRCCS, Rome, Italy.
G Bedogni
G Baviera
V Giorgio
E Porro
C Paris
P Giammaria
L Reali
F Anania
V Nobili
Istituti di Ricovero e Cura a Carattere Scientifico · ITAREA Science Park · ITBambino Gesù Children's Hospital · ITEmory University · US

Funding

The Role of Leptin in Liver FibrogenesisR01DK062092 · UNIVERSITY OF MARYLAND BALTIMORE · 2003 to 2005
$858k
BLRD VA I01 BX001746NIDDK NIH HHS DK062092NIDDK NIH HHS R01 DK062092NIDDK NIH HHS R56 DK062092
6 · The paper itself

Abstract

backgroundGut microbiota modifiers may have beneficial effects of non-alcoholic fatty liver disease (NAFLD) but randomised controlled trials (RCT) are lacking in children.

aimTo perform a double-blind RCT of VSL#3 vs. placebo in obese children with biopsy-proven NAFLD.

methodsOf 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.

resultsAt 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 aGLP1 increased in the VSL#3 group (P < 0.001 for all comparisons).

conclusionsA 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).

Indexed as

Dietary SupplementsAlanine TransaminaseBiopsyBody Mass IndexChildDouble-Blind MethodFatty LiverFemaleGlucagon-Like Peptide 1HumansInsulin ResistanceMaleNon-alcoholic Fatty Liver DiseaseObesityProbioticsSeverity of Illness IndexAlanine TransaminaseGlucagon-Like Peptide 1

Identifiers

PMID24738701
PMCPMC4046270
OpenAlexW2069354135

What Socratic holds

Textmetadata
LicenceTDM
Read underepoch 390

Registered trials

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the Socratic graph.