The Origins of a Probiotic Controvery
For many years, the probiotic known as VSL#3 was a highly regarded and well-researched medical food prescribed for various gastrointestinal conditions, including ulcerative colitis and irritable bowel syndrome. It was formulated by Professor Claudio De Simone and featured a proprietary, high-potency blend of eight specific bacterial strains. This original 'De Simone Formulation' was the subject of numerous clinical studies that demonstrated its effectiveness for managing inflammatory bowel diseases.
However, a significant shift occurred around 2016 when the inventor, Professor De Simone, terminated his relationship with the product's distributor, VSL Pharmaceuticals. Following this separation, De Simone took his original, extensively-researched formula and partnered with a new company, ExeGi Pharma. ExeGi Pharma now sells this original formulation under the new brand name, Visbiome, in the United States and Canada.
Meanwhile, the former partners continued to sell a product under the VSL#3 name, but with a different manufacturing process and formulation. This led to a significant and widely-reported legal dispute. A federal court found the sellers of the new VSL#3 liable for false advertising, as they were misleading consumers into believing they were still purchasing the original, clinically-proven product.
The Legal Ruling and Its Implications
The 2018 federal jury verdict was a watershed moment in the probiotic industry. The jury concluded that the product sold as VSL#3 was not the same formula that had been used in the original clinical studies. The court issued a permanent injunction to prevent the new VSL#3 sellers from making claims that falsely linked their product to the original De Simone Formulation.
This legal decision cemented the distinction between the two products. For patients and healthcare providers who relied on the research underpinning the original formula, the verdict provided crucial clarity. It established Visbiome as the sole carrier of the original, clinically-tested De Simone Formulation in the North American market.
Why the Formulas Are Different
The most critical difference between Visbiome and the current VSL#3 lies in the manufacturing process. Visbiome is manufactured according to the original De Simone specifications, using a dairy-based culturing process. While only trace amounts of dairy remain in the final product, this process is believed by the inventor to be essential for the health and vitality of the bacteria. In contrast, the current VSL#3 is manufactured differently, with dairy ingredients removed, and does not contain the same bacterial strain identification numbers, known as DSM numbers. This change in formulation and manufacturing means the clinical evidence supporting the original VSL#3 does not apply to the current VSL#3 product.
A Detailed Comparison: Visbiome vs. VSL3
| Feature | Visbiome | VSL#3 (Current) |
|---|---|---|
| Formulation | Original De Simone Formulation (DSF) | Different formulation, untested |
| Manufacturer | ExeGi Pharma, LLC | Alfasigma USA, Inc. / VSL Pharmaceuticals, Inc. |
| Clinical Support | Backed by over 100 clinical studies for the De Simone Formulation | None for the current formulation |
| Bacterial Strains | Contains the original 8 strains with specific DSM numbers | Contains 8 similar, but not identical, strains |
| Culturing Process | Uses dairy ingredients, trace amounts present | Dairy-free |
| Legal Status | Legally affirmed as containing the original formula | Found liable for false advertising regarding continuity claims |
| Availability (US/CA) | Widely available online and in pharmacies | Limited availability after the lawsuit |
Frequently Asked Questions About Visbiome and VSL3
- Where does the name "Visbiome" come from? The name Visbiome was adopted by ExeGi Pharma to market the original De Simone Formulation in the U.S. and Canada after the inventor's split with his former partners.
- Was the name VSL#3 simply replaced? No. After the split, Professor De Simone began selling his formula as Visbiome, while the former partners created a new, different probiotic and continued to market it under the VSL#3 name.
- How can I be sure I'm getting the original formula? To ensure you are receiving the formula used in the original clinical trials, you must purchase Visbiome, not the current VSL#3.
- Why are there different versions of VSL3 in Europe? In some regions, the original De Simone Formulation is sold under the name Vivomixx, further complicating the naming conventions. The current VSL3 is still available in some countries but has been legally challenged elsewhere.
- Does the different VSL3 formulation still work? The key issue is that the current VSL#3 formulation has not undergone the same rigorous clinical testing as the original De Simone Formulation. Any perceived effectiveness relies on anecdotal evidence, not the extensive body of research for the original formula.
Conclusion
The question of whether Visbiome and VSL3 are the same is not a simple one. The definitive answer is no, they are no longer identical products. A critical legal and manufacturing schism occurred in 2016, resulting in two distinct products with the same historical roots but different formulations. Visbiome carries the torch of the original, clinically-proven De Simone Formulation, while the current VSL#3 is a separate product that has faced legal challenges for false advertising. Consumers and health professionals should be aware of this distinction to ensure they are using the product with the extensive body of supporting research, which is now sold as Visbiome.
The Importance of the Original Formulation
For those managing specific gastrointestinal conditions, the specific formulation of a probiotic is paramount. The efficacy demonstrated in clinical trials for conditions like pouchitis and ulcerative colitis is tied directly to the precise combination and proportion of the bacterial strains in the De Simone Formulation. When a formulation is altered, even with similar strains, the clinical evidence is no longer guaranteed to be applicable. This is why the legal ruling and the creation of Visbiome as the true successor to the original formula are so important for patient care and transparency in the nutraceutical industry.
For further information on the original research and the change in products, you can consult sources like the Crohn's & Colitis Foundation's materials. The saga of Visbiome and VSL#3 highlights the vital importance of intellectual property and scientific integrity in the probiotic market, emphasizing that a brand name does not always guarantee a consistent product.
