De Simone Formulation

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The De Simone Formulation is a probiotic formula and manufacturing method developed by medical doctor Professor Claudio De Simone (MD, FAGA).

The De Simone Formulation has been clinically studied for a variety of health conditions since the 1990s but it has been researched the most for its efficacy in the medical management of chronic intestinal conditions including irritable bowel syndrome (IBS) and inflammatory bowel disease (IBD).

The probiotic formulation is classed as a high potency probiotic medical food in the United States. It is intended for the dietary management of dysbiosis (microbiota imbalance) associated with irritable bowel syndrome (IBS), antibiotic-associated diarrhea, ulcerative colitis (UC), pouchitis, hepatic encephalopathy (HE), pregnancy, for babies born by Caesarean Section (C-section), and for babies that are bottle-fed

History

Professor De Simone first patented the De Simone Formulation with the United States Patent and Trademark Office on February 10, 1998 under number 5,716,615.

The pharmaceutical distribution company, VSL Pharmaceuticals, Inc., later assigned the trademarked brand name VSL#3 to Professor De Simone’s probiotic formulation. The patent was re-issued on January 22, 2008 with Claudio De Simone as the sole inventor of the formulation sold at the time under the brand name VSL#3.

The De Simone Formulation was sold to consumers under the brand name VSL#3 from 2002 through May 2016. Since May 2016 the De Simone Formulation is no longer in the probiotic being sold under the brand name VSL#3.

North American distribution changed to ExeGi Pharma in 2016 and European distribution has been conducted by Mendes SA since 2015. The De Simone Formulation is sold under a number of different regional brand names including Visbiome in the United States and Canada and as Vivomixx in Europe including the United Kingdom.

Prior to May 2016, the De Simone Formulation selling under the brand name VSL#3, was researched in more than 70 human clinical trials. This pre-May 2016 clinical research using the De Simone Formulation has been published and referenced in hundreds of peer-reviewed medical and scientific journals under the name VSL#3.

All research on the De Simone Formulation since May 2016 is cited under either the De Simone Formulation reference or it is affiliated with various regional brand names.

Lawsuits

The De Simone Formulation has been the subject of lawsuits. In the United States, the 4th U.S. Circuit Court of Appeals upheld a false advertising verdict against the makers of the VSL#3 probiotic in February 2021 stating there was enough evidence to support a jury's November 2018 finding that the makers of VSL#3 had quote "reverse-engineered an imperfect copy" of De Simone's signature probiotic formulation that was sold under the brand name VSL#3 through May 2016 after he withdrew from their joint venture, VSL Pharmaceuticals Inc. According to the lawsuit, his departure was as a result of being pressured to substitute cheaper bacteria in the manufacturing process to lower production costs and raise profits. The Professor apparently refused. The makers of VSL#3 were ordered to pay Professor De Simone and ExeGi Pharma a combined total of $18 million (USD) in damages.

The Court also issued a permanent injunction intended to prevent claims, implied or stated, of continuity between the two different formulations. The court also cited public health and wellbeing concerns, when they blocked the makers of VSL#3 from linking their product with the original De Simone Formulation by referring to clinical studies that were executed using the De Simone Formulation prior to May 2016.

On August 1, 2019 the American Gastroenterology Association (AGA), the medical association of gastroenterologists in the United States, issued a correction regarding the De Simone Formulation and VSL#3. AGA's correction stated it had referenced studies referenced in its 2019 Technical Review on the Management of Mild-to-Moderate Ulcerative Colitis that were based on the probiotic formulation previously know by the brand name VSL#3 before May 2016, but was now known by the generic name ‘De Simone Formulation’.

On January 24, 2022, the European Crohn's and Colitis Organization (ECCO) issued a letter to the editor of Oxford Academic's Journal of Crohn's and Colitis (JCC) stating that as a result of a court injunction, the ECCO must provide a clarification note for changes relating to VSL#3 and the De Simone Formulation in their articles that reference or studied these probiotics.

Claudio De Simone

The probiotic formulation’s inventor, Professor Claudio De Simone, is an internationally recognized European academic in the field of probiotics and the human microbiota. He is a member of the American College of Gastroenterology. He is also a retired Professor of Infectious Diseases at the University of L’Aquila (Italy), where he specialized in gastroenterology, allergology, and clinical immunology.

Professor De Simone has been at the academic forefront for research of the human microbiome for decades. His interested in the human intestinal microbiota stems back to when the understanding of the importance of the role of the intestinal flora was just beginning. Since commercializing his De Simone Formulation, the Professor has actively campaigned for better regulation and quality control of probiotics based on potential risks to health and wellbeing.

The Professor developed the probiotic formulation known as the ‘De Simone Formulation’ in the 1990s. It is a mix of eight high concentration bacterial strains in a specific ratio.

References

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