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

Arushi Verma; Maria T Nelson; William R DePaolo; Christiane Hampe; Christian L Roth

doi:10.1007/s40200-021-00855-7

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

J Diabetes Metab Disord. 2021 Aug 8;20(2):1289-1300. doi: 10.1007/s40200-021-00855-7. eCollection 2021 Dec.

Authors

Arushi Verma^{1

2

3}, Maria T Nelson¹, William R DePaolo⁴, Christiane Hampe⁵, Christian L Roth^{2

6}

Affiliations

¹ Department of Pediatrics, University of Washington, Seattle, WA USA.
² Division of Pediatric Endocrinology, Seattle Children's Hospital, Seattle, WA USA.
³ Present Address: Department of Pediatrics, Division of Pediatric Endocrinology, University of Nevada Reno School of Medicine, 75 Pringle Way, Suite 505, Reno, NV 89521 USA.
⁴ Department of Medicine, Division of Gastroenterology, University of Washington, Seattle, WA USA.
⁵ Department of Medicine, Division of Endocrinology, University of Washington, Seattle, WA USA.
⁶ Center for Integrative Brain Research, Seattle Children's Research Institute, Seattle, WA USA.

Abstract

Purpose: The purpose of the study is to assess the effect of probiotic supplementation on gut microbiota and insulin resistance in adolescents with severe obesity.

Methods: Through a randomized, double blind, placebo-controlled, 12-week pilot clinical trial, 15 adolescents with severe obesity received either an oral probiotic 'Visbiome®' (n = 8) or placebo (n = 7). Anthropometry, fasting glucose, insulin, hs-CRP and stool for microbiome and calprotectin were collected at baseline (week 0) and 12 weeks after intervention.

Results: Among completers (n = 4 in each of the two groups), mean change in fasting glucose was significantly lower in the probiotic group (0 ± 4 mg/dL) as compared to the placebo group (6.3 ± 1.7 mg/dL) (p = 0.028). 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 ± 25.1 to 2.39 ± 2.0, respectively) but was not statistically significant (p = 0.06) as compared to in the placebo group (mean 12.8 ± 18.2 to 6.9 ± 5.61, respectively) (p = 0.89). Weight and BMI (mean ± SD) trended to remain stable in the treatment group (-1.07 ± 6.1 kg and -0.3 ± 2.2 kg/m² respectively) as compared to the placebo group (3.9 ± 5.1 kg, 1.0 ± 1.6 kg/m²) but was not significant (p = 0.12 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 > 0.05). One participant in the treatment arm reported adverse effects of gastrointestinal intolerance.

Conclusion: 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.

Supplementary information: The online version contains supplementary material available at 10.1007/s40200-021-00855-7.

Keywords: Adolescents; Gut microbiota; Obesity; Probiotics.

Associated data

ClinicalTrials.gov/NCT03109587

Grants and funding

P30 DK089507/DK/NIDDK NIH HHS/United States