FreQUENTLY ASKED QUESTIONS
General Questions
Visbiome® is a medical food intended for the dietary management of dysbiosis associated with irritable bowel syndrome (IBS), ulcerative colitis (UC), antibiotic associated diarrhea (AAD), pouchitis, and hepatic encephalopathy (HE). This product should not be used in premature infants in the Neonatal Intensive Care Unit (NICU) setting.
Visbiome is a high potency probiotic medical food, containing 8 strains of live bacteria.The De Simone Formulation in Visbiome® has been the subject of over 70 published clinical trials in human subjects, with extensive clinical research in the dietary management of dysbiosis associated with irritable bowel syndrome (IBS), ulcerative colitis (UC), antibiotic associated diarrhea (AAD), pouchitis, and hepatic encephalopathy (HE). Visbiome is a medical food intended for use under the supervision of a healthcare provider.
Visbiome should be stored under refrigeration. Store at (39-46°F, 4-8°C). Do not freeze.Visbiome can be stored at room temperature for up to one week without adversely affecting potency.
Primary Ingredients:
Lactobacillus acidophilus DSM24735™
Lactobacillus plantarum DSM24730™
Lactobacillus paracasei DSM24733™
Lactobacillus delbrueckii subsp. bulgaricus* DSM24734™
Streptococcus thermophilus DSM24731™
Bifidobacterium longum‡ DSM24736™
Bifidobacterium breve DSM24732™
Bifidobacterium infantis‡ DSM24737™
Capsule Inactive Ingredients: Microcrystalline cellulose (derived from plant fiber), and vegetable capsule (hydroxypropyl methylcellulose)
*Reclassified as L. helveticus
‡Reclassified as B. lactis
Visbiome® is a medical food as defined by the Orphan Drug Act and additional FDA regulations. Visbiome is not an FDA approved Drug.
No prescription is required; however, Visbiome should always be used under the supervision of a healthcare provider. Visbiome Extra Strength is a medical food which is dispensed by prescription.
Visbiome is lactose-free, gluten-free, non-GMO, and kosher-certified. VISBIOME contains milk. Some milk components are used as a fermentation nutrient. Trace amounts of milk protein may be present in the finished product. Lactose Status – VISBIOME is Lactose-free: Lactose was not detectable in amounts greater than 50 parts per million (PPM).
The capsules which contain Visbiome are made of hydroxypropyl-methylcellulose (HPMC) which is 100% vegetable cellulose and meets the strict dietary needs of consumers who choose a vegetarian lifestyle.
Visbiome is available in a powder and capsule format with 450 billion and 112.5 billion bacteria per dose respectively.Visbiome Extra Strength contains a higher concentration of bacteria (900 billion bacteria per packet) and is dispensed with a physician’s prescription.The products contain the same bacteria in the same concentrations and proportions.
Probiotics are often recommended to be taken in the morning on an empty stomach. However, there is not a recommended time of day to take Visbiome, so you may wish to follow your personal preference and consult with your healthcare provider when making this determination.
Visbiome Capsules or Visbiome Extra Strength do not contain cornstarch. Visbiome Unflavored does contain cornstarch.
Visbiome may be covered by some insurance providers and managed care organizations. Please consult with your insurance provider or managed care organization. Customers who do not receive insurance coverage or do not wish to seek coverage may purchase Visbiome Extra Strength directly from ExeGi at a discounted price with a healthcare provider's prescription.
Visbiome is manufactured in the United States.
Yes, Visbiome is available for purchase in Canada. Visit our Canadian website: www.Visbiome.ca or call 844-GUT-HEAL (844-488-4325) to learn more.
No, Visbiome does not contain any GMOs. All versions of Visbiome are non-GMO.
Safety
Certain strains contained in Visbiome may be inactivated by some types of antibiotics. Preferably, do not consume Visbiome within 4 hours after taking antibiotics. Visbiome may be consumed concomitantly with rifaximin (antibiotic) and/or lactulose in the dietary management of dysbiosis associated with hepatic encephalopathy.
Before receiving Visbiome Extra Strength you should tell your doctor if you:
- Are on antibiotics.
- Are pregnant or lactating.
You may experience bloating during the first few days after starting Visbiome Extra Strength as your intestinal microflora changes. If this occurs, you may need to reduce daily consumption to allow for adjustment. Please consult with your physician if you experience bloating.
VISBIOME contains milk. Some milk components are used as a fermentation nutrient. Trace amounts of milk protein may be present in the finished product. Lactose Status – VISBIOME is Lactose-free: Lactose was not detectable in amounts greater than 50 parts per million (PPM).
Ordering and Shipping
Visbiome can be ordered online at www.Visbiome.com or special ordered through most pharmacies. Visbiome can also be ordered over the phone by calling 844-FIT-GUTS (348-4887). Visbiome is available without a prescription, but it is a medical food which must be used under the supervision of a physician.
Visbiome Extra Strength is a medical food that is dispensed only by prescription. Visbiome Extra Strength can be special ordered through most pharmacies or ordered directly through ExeGi Direct. Visit www.Visbiome.com to Request Authorization. Your doctor can FAX your prescription to 866-612-7817.
Visbiome is shipped and stored cold to prevent elevated temperature exposure which could inactivate some of the live bacterial strains.Visbiome is stable at room temperature for up to one week without affecting potency.
Visbiome® is shipped with frozen ice packs to ensure it is maintained at temperatures. Your product may arrive at or around room temperature, depending on ambient conditions. Your order includes the following card, which incorporates a temperature monitoring sensor. This sensor is specially calibrated for Visbiome and helps ensure your order did not experience impactful heat events during transit to you. Temperature Monitor Please call customer service if you believe your product has been exposed to excessive heat at 844-FIT-GUTS (348-4887).
Yes, some pharmacies do stock Visbiome, but most will require 1-3 days to special order the product from local wholesalers. Please provide the following product code to your pharmacist:
Visbiome 30 Pack Unflavored –69355-0412-02
Visbiome Capsules 60 Count – 69355-0412-03
Visbiome Extra Strength 30 Pack – 69355-0516-01
FREE shipping (for the continental US) is the default option. There is a $34.95 Delivery Fee for customers in AK, HI, PR, and the Virgin Islands.
Overnight Delivery costs $29.99 for orders placed Monday-Thursday before 12:00 pm ET excluding holidays.
Visbiome Unflavored 30 Pack-69355-0412-02
Visbiome Capsules 60 Count-69355-0412-03
Visbiome Extra Strength 30 Pack-69355-0516-01
Dosing and Dietary Management With Visbiome®
The strains contained in Visbiome® have been selected not only for their specific individual characteristics but also for their synergistic activities. They work as a close team to perform what single strains or other combinations of strains may not do.
The Orphan Drug Act defines “medical food” as “a food which is formulated to be consumed or administered enterally under the supervision of a physician and which is intended for the specific dietary management of a disease or condition for which distinctive nutritional requirements, based on recognized scientific principles, are established by medical evaluation” [21 U.S.C. § 360ee(b)(3)]. The regulation in 21 C.F.R. 101.9(j)(8) sets forth additional criteria that a medical food must meet.This propriety formulation has been extensively studied in these target patient populations based on their unique dietary needs. The evaluation of the distinct nutritional requirement of these patient populations, and the role of the Visbiome™ formulation in addressing these needs, has been extensively characterized and evaluated by independent medical evaluation.
Consult with your healthcare provider and take Visbiome exactly as instructed. Visbiome Unflavored Powder can be mixed with 3-6 oz of any cold, non-carbonated beverage or any cold food, such as yogurt or applesauce, and consumed. Visbiome Capsules can be consumed directly. You may add Visbiome to any cold, non-carbonated smoothie. It is best to add Visbiome toward the end of the blending cycle. Consult with your physician before altering your daily consumption of Visbiome. You may experience bloating during the first few days after starting Visbiome as your intestinal microflora changes. If this occurs, you may need to reduce daily consumption to allow for adjustment. Please consult with your physician if you experience bloating.
Consult with your healthcare provider.
Yes, some pharmacies do stock Visbiome, but most will require 1-3 days to special order the product from local wholesalers. Please provide the following product code to your pharmacist:
Visbiome 30 Pack Unflavored –69355-0412-02
Visbiome Capsules 60 Count – 69355-0412-03
Visbiome Extra Strength 30 Pack – 69355-0516-01
Approximately 1-2 weeks. Consult with your healthcare provider.
Clinical trials have been conducted using Visbiome in varying amounts in the dietary management of pouchitis, ulcerative colitis, and irritable bowel syndrome (IBS). Please consult with your physician for recommended daily intake of Visbiome. Here is a link to the Visbiome Daily Intake Guidelines for adult and pediatric consumers.