Effects of Probiotics on Clinical, Biochemical and Radiological parameters in Obese Children with NASH /NAFLD in Combination with Dietary and Lifestyle Modification: A Randomised Control Trial

Abstract

Background: Childhood obesity is a global problem with metabolic abnormalities including NAFLD/ NASH. The gut liver axis is thought to play a major role in pathogenesis and altering it could affect the pathophysiological process. Probiotics are known to alter the gut microbiota and therefore could be a therapeutic option in the management of childhood obesity related complications. A double-blind, randomised, placebo control trial was conducted to evaluate the effects of probiotics on metabolic derangements in obese children with NAFLD/ NASH. Methods and Results: Obese children from the nutrition clinic conducted by University Paediatric Unit at Lady Ridgeway Hospital, Colombo with NAFLD/ NASH were recruited. Anthropometry, body fat, metabolic derangements and ultrasound scan (USS) of liver were evaluated at the beginning and at the end of 6 months. Transient elastography (Fibroscan®) was performed in a subsample of patients. Eighty-four patients were recruited and randomised into probiotics group (43) and placebo group (41). Mean age of the probiotic group was 11.3 years (+/-1.9 SD) and placebo group was 12.1 years (+/-1.5 SD). Baseline parameters including USS stage of the liver, body fat percentage, fasting blood sugars, lipid profile, liver functions and CRP showed no statistical difference. In the Probiotic group, statistically significant reduction of BMI was noted from baseline. However, the reduction was not significant when compared with the Placebo group. There was significant reduction in triglycerides, AST, ALT, AST/ ALT and ALP in placebo group over treatment period. Even though the USS stage of fatty liver showed improvement from stage II - III to stage I in a small number in the probiotic treated group, transient elastography performed in a subsample did not demonstrate significant improvement in either group. Conclusion: Our results indicate that there does not seem to be an advantage of probiotics over lifestyle modifications in improving obesity associated metabolic derangement in children