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 is NOT dairy free). Visbiome is Lactose free. Some of the bacteria strains are grown in a dairy environment and then blended with the rest of the strains to obtain the Visbiome Formulation. Processing methods are able to eliminate the lactose even though other milk components are left behind (similar to lactose-free milk).
When using the most sensitive test available to detect lactose down to a level of 50 parts per million, no lactose was found on Visbiome. In summary, when using the most sensitive analytical method available, no lactose was found in Visbiome.
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 75 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*1010) colony forming units (CFUs) per day for 12 weeks.
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