De Simone Formulation

The De Simone Formulation contained in CDS22-formula is the result of pioneering research by Professor Claudio De Simone (MD, FAGA), who redefined therapeutic approaches to intestinal health by introducing the use of high-concentration probiotic mixtures to dietetically manage acute and chronic gastrointestinal disorders.

His interest in the intestinal microbiota dates back to the 1980s when the importance of the intestinal flora’s role was just beginning to be understood. Professor De Simone is an honorary member of the American College of Gastroenterology and, after graduating in Medicine and Surgery, specialized in gastroenterology, allergology, and clinical immunology. He taught Infectious Diseases at the University of L’Aquila (Italy).

He has published over 200 clinical studies, scientific articles, and book chapters.

Since the commercial launch of his renowned De Simone Formulation in the 1990s, the Professor has actively advocated for better regulation and quality control of probiotics, highlighting the potential health and well-being risks.

As emphasized by Professor De Simone in numerous conferences and publications, many marketed probiotics have not been clinically tested or may not correspond to the original clinically tested formulations when marketed, causing substantial differences in the safety and efficacy of the final product (De Simone C. Clinical Gastroenterology and Hepatology Vol. 16 No. 9 2018).

Current regulations often do not require thorough comparative studies to ensure that changes in manufacturing processes do not compromise the efficacy and safety of the commercially distributed probiotic product.

There Is ONE
DeSimone Formulation

The lack of strict regulation and the possibility for manufacturers to modify formulations without adequately informing consumers pose a threat to public trust. In the past, the De Simone Formulation (DSF) was sold under the brand name VSL#3©, by VSL Pharmaceuticals and Actial Srl.

In 2019, VSL7#© distributors were found guilty of false advertising (for more information: Federal Judge Upholds $18M Verdict, Blocks False Advertising of VSL#3, schulman Bhattacharya). Recently, the European Crohn’s and Colitis Organisation (ECCO) has updated its guidelines to clarify that pre-2016 literature references to VSL#3 exclusively refer to DSF (ECCO, ECCO News,2023). In 2024 ESPEN (European Society for Clinical Nutrition and Metabolism) published the article "Clarify Correct Amition in Scientific Literature: The Case of the DeSimone Formulation and VSL#3©"which reiterates the above.

The De Simone Formulation is sold under the brand name "Visbiome"¸ in the USA and Canada (Exegi) and under the brand name "De Simone Formulation"¸ in Korea (HectoHealthcare).

Soon to be Available in the EU under the brand CDS22-formula.

*is a register trademark of VSL Pharmecuticals and Actial Srl Inc, independent companies from EOS2021 S.r.l