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Reply to ‘Simpson’s paradox in proof-of-concept studies’

Nature Medicine volume 25, pages 1640–1641 (2019)Cite this article

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Cani and Depommier reply: We appreciate the correspondence from Janket et al.1 and their support concerning our study2 showing that three months of supplementation with 10 billion Akkermansia muciniphila bacteria, either live or pasteurized, was safe and well tolerated and improved several cardiovascular risk factors in subjects with metabolic syndrome.

We agree with most of the points they make about the general design of pilot studies and the necessity of carefully monitoring confounding factors to mitigate the potential effects of Simpson’s paradox. In their comments, they raise the interesting point that subjects should be stratified according to diet and physical activity in order to avoid any additional confounding effects. We fully agree with this, as this is exactly what we did in our pilot study. All subjects were carefully selected based on numerous criteria, including physical activity and dietary habits as determined using deep anamnesis, which was among tests we used; these also included a validated dietary questionnaire and blood analysis.

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References

  1. Janket, S.-J., Ackerson, L.K & Diamandis, E. Nat. Med. https://doi.org/10.1038/s41591-019-0624-y (2019).

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Authors and Affiliations

  1. Metabolism and Nutrition Research Group, Louvain Drug Research Institute, Walloon Excellence in Life Sciences and BIOtechnology (WELBIO), UCLouvain, Université Catholique de Louvain, Brussels, Belgium

    Patrice D Cani & Clara Depommier

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  1. Patrice D Cani
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  2. Clara Depommier
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Corresponding author

Correspondence to Patrice D Cani.

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Competing interests

P.D.C. is an inventor on patent applications (PCT/EP2013/073972; PCT/EP2016/071327, and PCT/EP2016/060033 filed with the European Patent Office (EP) and the patent offices of Australia (AU), Brazil (BR), Canada (CA), China (CN), Eurasian Patent Organization (EA), Israel (IL), India (IN), Hong Kong (HK), Japan (JP), South Korea (KR), Mexico (MX), New Zealand (NZ), and the United States (US)) dealing with the use of A. muciniphila and its components in the context of obesity and related disorders. P.D.C. is a co-founder of A-Mansia Biotech SA.

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Cani, P.D., Depommier, C. Reply to ‘Simpson’s paradox in proof-of-concept studies’. Nat Med 25, 1640–1641 (2019). https://doi.org/10.1038/s41591-019-0625-x

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