Evidence map›Paper›PMID 34773939›Full record

ArticleClinical and experimental pediatrics2022

Effects of probiotics combined with dietary and lifestyle modification on clinical, biochemical, and radiological parameters in obese children with nonalcoholic fatty liver disease/nonalcoholic steatohepatitis: a randomized clinical trial.

Thushara Rodrigo, Samaranayake Dulani, Sumudu Nimali Seneviratne, Arjuna P De Silva, Jerad Fernando, H Janaka De Silva, Jayasekera, V Pujitha Wickramasinghe

Open access · diamondAbstract read
PubMed Full text at PMC Publisher
In one paragraph

Article in Clinical and experimental pediatrics, 2022. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 21 papers, 8 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
21citing papers in PubMed, 8 pooled it
3.9field-weighted citation impact, top 5% 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.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

21 citing papers in PubMed, 8 syntheses or guidelines pooled it, 36 citations in OpenAlex.

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4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

8 authors at 3 institutions in 1 country.

Thushara RodrigoPost Graduate Institute of Medicine, Faculty of Medicine, University of Colombo, Colombo, Sri Lanka.
Samaranayake DulaniDepartment of Community Medicine, Faculty of Medicine, University of Colombo, Colombo, Sri Lanka.
Sumudu Nimali SeneviratneDepartment of Pediatrics, Faculty of Medicine, University of Colombo, Colombo, Sri Lanka.
Arjuna P De SilvaDepartment of Medicine, Faculty of Medicine, University of Kelaniya, Kelaniya, Sri Lanka.
Jerad FernandoDepartment of Radiology, Lady ridgeway Hospital for Children, Colombo, Sri Lanka.
H Janaka De SilvaDepartment of Medicine, Faculty of Medicine, University of Kelaniya, Kelaniya, Sri Lanka.
JayasekeraDepartment of Pediatrics, Faculty of Medicine, University of Colombo, Colombo, Sri Lanka.
V Pujitha WickramasingheDepartment of Pediatrics, Faculty of Medicine, University of Colombo, Colombo, Sri Lanka.
University of Colombo · LKUniversity of Kelaniya · LKLady Ridgeway Hospital for Children · LK

Funding

Probiotics International Ltd
6 · The paper itself

Abstract

backgroundChildhood obesity is a global problem associated with metabolic abnormalities. The gut-liver axis is thought to play a major role in its pathogenesis. Probiotics are known to alter the gut microbiota and, therefore, could be a therapeutic option in the management of childhood obesity-related complications. PURPOSE: This double-blind randomized placebo-controlled trial evaluated the effects of probiotics on metabolic derangement in obese children with nonalcoholic fatty liver disease/ nonalcoholic steatohepatitis (NAFLD/NASH).

methodsObese children with NAFLD/NASH treated at the nutrition clinic of the University Paediatric Unit at Lady Ridgeway Hospital, Colombo, were recruited. Anthropometry, body fat, metabolic derangement, and liver ultrasound scan (USS) results were evaluated at baseline and after 6 months. Transient elastography (FibroScan) was performed on a subsample of these patients. Eighty-four patients were recruited and randomized into the probiotics (n=43) and placebo (n= 41) groups. The mean age was 11.3±1.9 versus 12.1±1.5 years in the probiotic and placebo groups, respectively. Baseline parameters including liver disease stage on USS, body fat percentage, fasting blood sugar, lipid profile, liver function, and C-reactive protein showed no significant intergroup differences.

resultsIn the probiotic group, a statistically significant reduction in body mass index was noted from the baseline value. However, the reduction was not significant compared with the placebo group. There was a significant reduction in triglycerides, aspartate transaminase (AST), alanine aminotransferase (ALT), AST/ALT ratio, and alkaline phosphatase in the placebo group over the treatment period. Although the liver disease stage on USS improved from stage II-III to stage I in a small number of patients in the probiotic-treated group, transient elastography performed in a subsample did not demonstrate significant improvement in either group.

conclusionOur results indicate that probiotics have no advantage over lifestyle modification for improving obesityassociated metabolic derangement in children.

Indexed as

Metabolic syndromeNonalcoholic fatty liver diseaseNonalcoholic steatohepatitisObesityProbiotics

Identifiers

PMID34773939
PMCPMC9171460
OpenAlexW3211915656

What OpenQuestion holds

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LicenceCC BY-NC
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Registered trials

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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 OpenQuestion graph.