Important Safety Information

Side Effects

Mild abdominal bloating has been reported in the first few days of consuming Visbiome™. This is generally a physiological adaptation of the microflora, which usually diminishes within 3-4 days. If bloating persists, the patient should reduce his or her intake for a few days.

Precautions

Please keep this product out of reach of children. This product should not be used in premature infants in the Neonatal Intensive Care Unit (NICU) setting. All users, especially pregnant or lactating women, should consult with a physician or healthcare professional before using this or any other medical food product.

Allergen Warning - Contains milk. Visbiome™ may contain trace amounts of lactose (less than 0.1g per 100g) and dehydrated skim milk or milk protein (casein and beta-lacto globulin of less than 2mg/Kg).

Safety

Probiotics have a long history of safe use, having been consumed for health benefit and as part of fermented foods for millennia. 16,17,18,19 Many bifidobacteria and lactobacilli species are normal, nonpathogenic inhabitants of the human gastrointestinal tract, oral cavity, skin, and vagina. 16,17,20,21 Documented cases of infection attributable to probiotic intake are limited to individual case reports, primarily associated with the use of probiotics in severely immunocompromised patients, but never reported for VISBIOME.

The probiotic bacteria in VISBIOME are non-pathogenic, non-toxigenic and Generally Recognized as Safe (GRAS) as food ingredients.

The De Simone Formulation in VISBIOME has been the subject of over 60 clinical studies involving over 5,000 adult and pediatric patients (ages 1.7 - 17). The most common reported adverse events are abdominal bloating and/or gas, generally reported within the first few days of probiotic consumption.

VISBIOME has been administered in clinical evaluation in daily dosages of up to 3,600 billion (360 x 1010) colony forming units (CFUs) per day for 12 weeks.

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