Clin Exp Pediatr > Accepted Articles
DOI:    [Accepted]
Published online November 11, 2021.
Effects of probiotics combined with dietary and lifestyle modification on clinical, biochemical, and radiological parameters in obese children with NASH/NAFLD: a randomized clinical trial
Thushara Rodrigo1  , Samaranayake Dulani2, Sumudu Nimali Seneviratne3  , Arjuna P. De Silva4, Jerad Fernando5, H. Janaka De Silva4  , Jayasekera 3, V. Pujitha Wickramasinghe3 
1Post Graduate Institute of Medicine, Faculty of Medicine, University of Colombo, Colombo, Sri Lanka
2Department of Community Medicine, Faculty of Medicine, University of Colombo, Colombo, Sri Lanka
3Department of Pediatrics, Faculty of Medicine, University of Colombo, Colombo, Sri Lanka
4Department of Medicine, Faculty of Medicine, University of Kelaniya, Kelaniya, Sri Lanka
5Department of Radiology, Lady ridgeway Hospital for Children, Colombo, Sri Lanka
Thushara Rodrigo, Email:
Received: 4 June 2021   • Revised: 29 September 2021   • Accepted: 23 October 2021
Childhood 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.
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).
Obese 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.
In 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.
Our results indicate that probiotics have no advantage over lifestyle modification for improving obesity-associated metabolic derangement in children.
Key Words: Obesity, Metabolic syndrome, NAFLD, NASH, Probiotics

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