The original De Simone Formulation, developed through decades of scientific research in microbiota science.

A Legacy of Innovation in Probiotics

drdesimone.net is dedicated to preserving and distributing the original De Simone Formulation, while also developing and offering additional scientifically designed formulations for specific clinical and functional needs.

Founded on decades of research led by Prof. Claudio De Simone (MD, FAGA), our work reflects a broader commitment to evidence-based probiotic science and innovation.

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A pioneer in microbiota science and probiotic research.

Prof. Claudio De Simone

A career dedicated to advancing microbiota research and probiotic science.

Academic and Professional Journey

Formerly professor of Infectious Diseases (Italy, University of L'Aquila), with a background in gastroenterology, allergology and clinical immunology, his academic career has been marked by a continuous commitment to research, clinical application, and regulatory standards in probiotic development.

Over the years, Prof. De Simone's work contributed to defining quality criteria for strain selection, formulation stability, and evidence-based use of probiotics in the dietary management of gastrointestinal conditions. This scientific approach remains at the core of the original De Simone Formulation today.

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The Original Scientific Formulation

The De Simone Formulation

Introduced in the 1990s, the De Simone Formulation represents a milestone in evidence-based probiotic development.

Supported in more than 25 years by over 200 scientific publications and 80+ clinical studies, it has been extensively investigated in the dietary management of gastrointestinal conditions.

Its recognition by leading scientific societies, including European Crohn's and Colitis Organization (ECCO) and American Gastroenterology Association (AGA), reflects the rigor of its strain selection, formulation stability, and clinical validation.

Only products explicitly identified as containing the De Simone Formulation (CDS22-formula) correspond to that literature-defined formulation.

The history of an original scientific identity

Developed by Prof. Claudio De Simone, the original De Simone Formulation has travelled through different markets, brands and scientific milestones. Its identity has been preserved, defended and clarified over time — by the inventor, by the scientific record and by formal attribution.

Today, CDS22-formula makes the original De Simone Formulation available in the EU and UK under its current brand name.

Late 1980s – 1990s

The scientific origin

Prof. Claudio De Simone begins his research into the intestinal microbiota and develops the original high-concentration, 8-strain probiotic formulation.

Early 2000s

First commercialised as VSL#3®

The formulation is commercialised internationally under the VSL#3®(1) brand, beginning its broad clinical and commercial history.

2016 · The turning point

Brand and formulation separate

Prof. De Simone ends his partnership with the VSL#3® distributor and retains his formulation. The original formulation moves to new manufacturing and becomes available under new regional brands — Visbiome®(2) in North America and Vivomixx®(3) in Europe and the UK — while the VSL#3®(1) name continues on a different, reformulated product.

2018 – 2021

Legal clarification in the United States

A federal jury (November 2018, District of Maryland) finds in favour of Prof. De Simone and ExeGi Pharma, awarding over US$18 million for false advertising under the Lanham Act. A 2019 permanent injunction and a 2021 Fourth Circuit affirmation(4) confirm the distinction between the original De Simone Formulation and the later, different product marketed under the VSL#3® brand.

2023-2024

Scientific attribution clarified

ECCO issues correction and clarification notices; a 2024 article in Clinical Nutrition addresses correct attribution; AGA clinical practice guidance(5) cites the De Simone Formulation by name as the formulation used in the relevant trials.

2025 onward

CDS22-formula in the EU and UK

CDS22-formula makes the original De Simone Formulation available in the EU and UK under its current brand name — continuing the same formulation identity.

Trademark, attribution and reference notes

(1) VSL#3® is a third-party registered trademark held, depending on jurisdiction, by entities including VSL Pharmaceuticals Inc. and Actial Farmaceutica S.r.l., independent of EOS2021 S.r.l. Any historical reference to VSL#3® identifies solely the former brand name under which the De Simone Formulation was commercialised during the relevant period.
(2) Visbiome® is a trademark of ExeGi Pharma LLC and refers to the brand under which the De Simone Formulation is available in the United States and Canada.
(3) Vivomixx® is a trademark of Mendes S.A., independent of EOS2021 S.r.l. References to Vivomixx® are historical and geographical only and do not imply that every product currently sold under similar or successor names is the De Simone Formulation.
(4) US litigation. A November 2018 federal jury verdict (over US$18 million, false advertising under the Lanham Act) was followed by a 2019 permanent injunction and a 2021 U.S. Court of Appeals for the Fourth Circuit affirmation. In 2025 a US federal court granted class certification in a consumer action alleging that VSL#3® continued to be marketed as if it contained the original formulation despite the post-2016 change; these remain allegations pending final adjudication. Source →
(5) Scientific references. ECCO, ESPEN-linked literature and AGA references are included solely for scientific attribution and historical context. They are provided only to identify the formulation used in historical studies and to clarify scientific attribution; they are not intended to present CDS22-formula as a medicinal product or to make authorised health claims.

ECCO/JCC: academic.oup.com ·  Clinical Nutrition (2024): clinicalnutritionjournal.com ·  AGA: gastrojournal.org
CDS22-formula is a food supplement. These references do not constitute medical advice, therapeutic recommendations, or claims regarding the prevention, treatment or cure of any disease.

CDS22-formula is the current EU and UK brand under which the original De Simone Formulation is made available.
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Scientific portfolio

Beyond a Single Formulation

While the De Simone Formulation represents a milestone in probiotic research and remains our flagship formulation, our portfolio is not limited to a single composition.

We develop and distribute additional proprietary formulations designed for specific applications and evolving scientific objectives.

Each formulation is defined by its own composition, intended use and technical specifications.

What connects them is the same principle: clear formulation identity, scientific seriousness and careful quality standards.

Preserving the original standards established through clinical research.

Commitment to Quality and Scientific Integrity

At DrDesimone.net, our commitment goes beyond distribution. We work to ensure that the original De Simone Formulation is preserved according to the scientific specifications defined during its development.

From controlled manufacturing processes to temperature-managed handling, every step reflects the standards of quality, stability, and authenticity that underpin decades of research.

Our goal is to maintain continuity with the original formulation while advancing new scientifically grounded developments, guided by evidence and delivered with responsibility.