A randomized double-blind placebo controlled pilot study of probiotics in adolescents with severe obesity

Abstract

The purpose of the study is to assess the effect of probiotic supplementation on gut microbiota and insulin resistance in adolescents with severe obesity. Through a randomized, double blind, placebo-controlled, 12-week pilot clinical trial, 15 adolescents with severe obesity received either an oral probiotic ‘Visbiome®’ (n\u2009=\u20098) or placebo (n\u2009=\u20097). Anthropometry, fasting glucose, insulin, hs-CRP and stool for microbiome and calprotectin were collected at baseline (week 0) and 12 weeks after intervention. Among completers (n\u2009=\u20094 in each of the two groups), mean change in fasting glucose was significantly lower in the probiotic group (0\u2009±\u20094 mg/dL) as compared to the placebo group (6.3\u2009±\u20091.7 mg/dL) (p\u2009=\u20090.028). Gut microbial Firmicutes to Bacteroidetes (F/B) ratio had a greater decline from week 0 to week 12 in the probiotic group (mean 17.7\u2009±\u200925.1 to 2.39\u2009±\u20092.0, respectively) but was not statistically significant (p\u2009=\u20090.06) as compared to in the placebo group (mean 12.8\u2009±\u200918.2 to 6.9\u2009±\u20095.61, respectively) (p\u2009=\u20090.89). Weight and BMI (mean\u2009±\u2009SD) trended to remain stable in the treatment group (-1.07\u2009±\u20096.1 kg and -0.3\u2009±\u20092.2 kg/m2 respectively) as compared to the placebo group (3.9\u2009±\u20095.1 kg, 1.0\u2009±\u20091.6 kg/m2) but was not significant (p\u2009=\u20090.12 for weight and 0.38 for BMI). No significant change in the fasting insulin, HOMA-IR, or serum and stool inflammatory markers were noted between the two groups (p\u2009>\u20090.05). One participant in the treatment arm reported adverse effects of gastrointestinal intolerance. Probiotic therapy with Visbiome® may improve the fasting glucose and possibly decrease the gut microbial F/B ratio as compared to placebo in adolescents with severe obesity. Future larger studies are required to confirm these findings. U.S. Clinical Trial Registry number: NCT03109587