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A randomized, double-blind, placebo-controlled clinical study to evaluate the efficacy of the synbiotic medical food, SBD111, for the clinical dietary management of bone loss in menopausal women

Crossref DOI link: https://doi.org/10.1007/s00198-025-07650-7

Published Online: 2025-08-15

Published Print: 2025-10

Update policy: https://doi.org/10.1007/springer_crossmark_policy

Authors

Schott, Eric M. https://orcid.org/0000-0001-6202-2799
Charbonneau, Mark R.

Kiel, Douglas P.

Bukata, Susan

Zuscik, Michael J.

Rosen, Clifford

Ballok, Alicia

Toledo, Gerardo V.

Steels, Elizabeth

Huntress, Harry

Rao, Amanda

Ebelt, Phillippa

Travison, Thomas G.

Soto-Giron, Maria J.

Wolff, Ian

Easson, D. Davidson Jr.

Engelke, Klaus

Vitetta, Luis
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Article History

Received: 21 May 2025

Accepted: 29 July 2025

First Online: 15 August 2025

Declarations

:

: The study was conducted in accordance with the Declaration of Helsinki, and approved by the National Institute of Integrative Medicine Human Research Ethics Committee (EC00436) in Brisbane, QLD, Australia (Reference Number: 0089E_2021, August 26, 2021).

: Eric Schott, Mark Charbonneau, Alicia Ballok, Gerardo Toledo, Maria Juliana Soto-Giron, Ian Wolff, and D. Davidson Easson are employees of Solarea Bio. Douglas Kiel, Susan Bukata, Michael Zuscik, and Clifford Rosen are advisors of Solarea Bio. Douglas Kiel received grant funding from Solarea Bio to conduct a human safety and tolerability clinical trial and has received an NIH RO1 (R01AG079952) to conduct a clinical trial of SBD111 in women over 60-years of age. Klaus Engelke is a part time employee of Clario. Elizabeth Steels, Harry Huntress, Amanda Rao, Phillippa Ebelt, Thomas Travison, and Luis Vitetta declare they have no conflicts of interest.

: Informed consent was obtained from all subjects involved in the study.

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