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

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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

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Data availability

Data and materials are available upon request.

Code availability

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Acknowledgements

We acknowledge the efforts of Cordelia Franklin and Sue Kearns in helping participants schedule for study visits.

Funding

This research was funded by the Office of Research Central, University of Washington (grant A118785 Royalty Research Fund, Pilot Study of Synbiotics in Pre-diabetic Adolescents).

Author information

Author notes

  1. Arushi Verma

    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

Authors and Affiliations

  1. Department of Pediatrics, University of Washington, Seattle, WA, USA

    Arushi Verma & Maria T. Nelson

  2. Division of Pediatric Endocrinology, Seattle Children’s Hospital, Seattle, WA, USA

    Arushi Verma & Christian L. Roth

  3. Department of Medicine, Division of Gastroenterology, University of Washington, Seattle, WA, USA

    William R. DePaolo

  4. Department of Medicine, Division of Endocrinology, University of Washington, Seattle, WA, USA

    Christiane Hampe

  5. Center for Integrative Brain Research, Seattle Children’s Research Institute, Seattle, WA, USA

    Christian L. Roth

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  1. Arushi Verma
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Contributions

Conceptualization, Christian L. Roth, Christiane Hampe and William R. DePaolo; Data curation, Arushi Verma and Maria T. Nelson; Formal analysis, Arushi Verma, Maria T. Nelson and Christian L. Roth; Funding acquisition, Arushi Verma, William R. DePaolo, Christiane Hampe and Christian L. Roth; Investigation, Arushi Verma, William R. DePaolo and Christian L. Roth; Methodology, Arushi Verma and Christian L. Roth; Project administration, Arushi Verma and Christian L. Roth; Resources, William R. DePaolo, Christiane Hampe and Christian L. Roth; Software, Maria T. Nelson; Supervision, Christian L. Roth; Validation, William R. DePaolo and Christian L. Roth; Visualization, Arushi Verma, William R. DePaolo and Christian L. Roth; Writing – original draft, Arushi Verma; Writing – review & editing, Arushi Verma, Maria T. Nelson, William R. DePaolo and Christian L. Roth.

Corresponding author

Correspondence to Arushi Verma.

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This study was approved by the institutional IRB (Seattle Children’s IRB).

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The authors declare no conflict of interest. The funders had no role in the design of the study, in the collection, analyses, or interpretation of data; in the writing of the manuscript, or in the decision to publish the results.

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Verma, A., Nelson, M.T., DePaolo, W.R. et al. A randomized double-blind placebo controlled pilot study of probiotics in adolescents with severe obesity. J Diabetes Metab Disord 20, 1289–1300 (2021). https://doi.org/10.1007/s40200-021-00855-7

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