Probiotics

The probiotic market for use as foods and supplements has grown rapidly in recent years, but its regulation varies across regions. Probiotics are categorised as food supplements and do not come under the same regulatory framework as pharmaceutical drugs or medical devices. However, to maintain the stability of probiotic bacteria, specific manufacturing standards must be respected for the culture, the growth phase, purification, lyophilisation, blending and handling. In addition, probiotics are most often temperature-sensitive, and ongoing storage in a refrigerator is essential for viability.

The proprietary De Simone Formulation (DSF), invented by Professor of infectious disease and immunology – Claudio De Simone, is a highly concentrated probiotic food supplement containing eight strains of Lactobacilli and Bifidobacteria to help to maintain a healthy digestive system. The strains included in the blend have been selected for their specific characteristics and for their capacity to work in synergy and achieve what individual strains or other combinations of strains cannot.

The DSF contains 450 billion active bacteria per sachet (the equivalent of 360 yoghurts) and 112 billion per capsule. These quantities are necessary to ensure that sufficient numbers of bacteria survive the conditions in your intestinal tract to colonise your gut and provide a healthy balance of good bacteria.
The DSF formulation survives gastric fluid, bile, and pancreatic secretions, allowing it to reach and colonise the gastrointestinal tract. While the mechanism of action has not been elucidated, it has been shown to enhance the intestinal epithelial barrier structure and function, reduce inflammation, and stimulate the protective immune response.

Probiotics have a major role in the health challenges that confront us, including the fight against viruses, antibiotic resistance and neurodegenerative disorders. The DSF is one of the most widely studied probiotics and has been the subject of more than 70 clinical studies on individuals of all ages, resulting in over 250 original publications and being approved by the major international gastroenterology associations. Data has been published that shows the benefits of the DSF in several conditions, including:

• Irritable bowel syndrome
• Inflammatory bowel disease / ulcerative colitis
• Pouchitis
• Crohn’s disease
• Radiation-induced diarrhoea
• Chemotherapy-induced diarrhoea
• Liver diseases (portal hypertension, hepatic encephalopathy, non-alcoholic fatty liver disease)
• Obesity and type 2 diabetes
• Critically ill patients
• Human immunodeficiency virus (HIV)
• COVID-19
• Other (viral and bacterial conditions, antibiotic-associated diarrhoea, diverticulitis, infantile colic, multiple sclerosis, pregnancy, autism)