25 Years of the De Simone Formulation providing relieve

A Milestone in Probiotic Science

This month marks 25 years since the publication of the first clinical study on the De Simone Formulation, a high potency probiotic blend that has helped reshape approaches to chronic digestive disorders.

A Breakthrough That Changed the Field

In August 2000, Professor Paolo Gionchetti and colleagues at the University of Bologna published a landmark study in a leading medical journal. Their findings were groundbreaking: for the first time, a probiotic formulation demonstrated clear, statistically significant benefits compared to placebo in a rigorous clinical trial. The condition in focus—pouchitis, an inflammatory complication that can arise in patients who undergo ileal pouch surgery—suddenly had a natural and effective management option.

At the time, the concept of using beneficial bacteria to maintain remission in a serious inflammatory condition was revolutionary. That study marked the beginning of a new era for probiotics—one built not just on theory, but on solid clinical evidence.

25 Years of Clinical Impact

Since that pivotal moment, the De Simone Formulation has become one of the most extensively studied probiotics in the world, featured in more than 100 clinical trials across a wide range of gastrointestinal disorders.

• Recognized in guidelines: Leading professional societies, including the American Gastroenterological Association (AGA)¹ and the European Crohn’s and Colitis Organisation (ECCO)², have included the formulation in their treatment recommendations.
• Broad patient impact: Beyond pouchitis, the formulation is now used in the dietary management of irritable bowel syndrome (IBS), ulcerative colitis, and antibiotic-associated diarrhea, offering patients a safe and effective way to support gut health.
• A trusted tool: Physicians worldwide continue to rely on this evidence-based probiotic solution, backed by decades of scientific validation.

From Discovery to Visbiome®

The formulation was originally developed by Professor Claudio De Simone, MD, who combined specific strains of live bacteria into a unique high potency probiotic blend. Now this formula is known as the De Simone Formulation.

In 2016, ExeGi Pharma partnered with Professor De Simone to bring this product to patients in the United States under the brand name Visbiome. Since its launch, ExeGi has ensured that patients and healthcare providers continue to have access to the same high-quality probiotic used in clinical trials—produced with uncompromising standards and an unchanged composition.

The company has also broadened access in recent years. In 2018, it introduced Visbiome Vet, extending the benefits of the De Simone Formulation to animal health. More recently, ExeGi launched a flavored version named Visbiome GI Care Kids, designed for children and for anyone who prefers a wild berry-flavored alternative to the unflavored powder, making daily use more accessible.

Looking Ahead

As the De Simone Formulation reaches its 25th anniversary, its legacy continues to grow. ExeGi Pharma remains dedicated to advancing probiotic research and supporting both patients and healthcare professionals with innovative microbiome-based solutions. This milestone not only celebrates history but also points toward the future of gastrointestinal care.

1. Ko et al., AGA Clinical Practice Guidelines on the Management of Pouchitis and Inflammatory Pouch Disorders. Gastroenterology. 2023;164(4):1031–1048.

2. Magro et al., Third European Evidence-based Consensus on Diagnosis and Management of Ulcerative Colitis. Part 1: Definitions, Diagnosis, Extra-intestinal Manifestations, Pregnancy, Cancer Surveillance, Surgery, and Ileo-anal Pouch Disorders. J Crohns Colitis. 2017;11(6):649–670.