The De Simone Formulation is a

probiotic Probiotics are live microorganisms that provide health benefits when consumed, generally by improving or restoring the microbiota in the gut. Probiotics are considered generally safe to consume, but may cause bacteria– host interactions ...

formula and manufacturing method developed by Claudio De Simone. 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 Irritable bowel syndrome (IBS) is a functional gastrointestinal disorder characterized by a group of symptoms that commonly include abdominal pain, abdominal bloating, and changes in the consistency of bowel movements. These symptoms may ...

(IBS) and

inflammatory bowel disease Inflammatory bowel disease (IBD) is a group of inflammatory conditions of the colon and small intestine, with Crohn's disease and ulcerative colitis (UC) being the principal types. Crohn's disease affects the small intestine and large intestine ...

(IBD).

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

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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. Court action states that De Simone apparently refused. The makers of VSL#3 were ordered to pay De Simone and ExeGi Pharma a combined total of $18 million (USD) in damages. The Court also issued a permanent

injunction An injunction is an equitable remedy in the form of a special court order compelling a party to do or refrain from doing certain acts. It was developed by the English courts of equity but its origins go back to Roman law and the equitable rem ...

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 Clinical trials are prospective biomedical or behavioral research studies on human participants designed to answer specific questions about biomedical or behavioral interventions, including new treatments (such as novel vaccines, drugs, dietar ...

that were executed using the De Simone Formulation prior to May 2016.

Scientific research

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 formulation name 'De Simone Formulation'. On January 24, 2022, th
European Crohn's and Colitis Organisation (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.

References

{{Reflist Probiotics Medical food Therapy Gastroenterology Microbiomes