Visbiome is a high-potency probiotic medical food intended for the dietary management of dysbiosis associated with IBS (irritable bowel syndrome), UC (ulcerative colitis), pouchitis, and hepatic encephalopathy (HE).
People wonder if it is worth the price, because it can be expensive. Read on because this page can help you decide.
Visbiome is sometimes used by physicians for Crohn’s disease, but that is technically an “off-label” use (a prescription-drug term). It has been shown in a study to help prevent Crohn's in the early stages in mice, and a clinical trial was planned in children with Crohn’s disease, but plans have not materialized as of this writing (late November, 2019).
It is produced by ExeGi Parma and is a product of the USA.
Visbiome is a medical food, meaning:
Medical foods are NOT drugs.
Visbiome is composed of 8 strains of lactic acid bacteria in certain ratios to produce a specific biochemical and immunological profile called the “De Simone Formulation”:
Please note that the strains are grown using dairy ingredients.
At first glance, Visbiome may seem to be the same product as VSL#3. In fact, Visbiome and VSL#3 contained the same proven probiotics and formulation before January 31, 2016. Now the two products are NOT the same, however, and a legal battle has settled that question.
The history, in a brief summary, is that Professor Claudio De Simone, MD, a researcher and clinician based out of Rome, Italy, created VSL, "Very Safe Lactobacilli", in high-strength formulas. The product was licensed to VSL Pharmaceuticals by Professor De Simone, and produced in an agreement with Danisco (now DuPont). VSL#3, the trademark owned by VSL Inc., was first marketed in the US in 2003.
As business agreements sometimes go, Professor De Simone terminated his relationship with VSL Inc. as a result of differing ideas about certain production requirements for the product. Professor De Simone blocked VSL Inc. from accessing his formulation and granted a new license to ExeGi Pharma. Since Professor De Simone never owned the trademark VSL#3, ExeGi Pharma could not use the same name, so in 2016 ExeGi Pharma launched the De Simone formulation as Visbiome.
VSL Inc no longer had any right to access the De Simone formulation produced at DuPont for ExeGi Pharma, but as court records show, a Maryland Federal jury in November, 2018 unanimously held VSL Pharmaceuticals Inc., Leadiant Biosciences Inc. and Alfasigma USA Inc. liable for false advertising for continuing to deceive patients, doctors, and other stakeholders by creating a "knock-off" product of Visbiome and referencing scientific studies based on Visbiome and not the new VSL#3 formulation.
The current VSL#3 does not have the same strains in the same proportions, nor is it cultured the same as Visbiome. Therefore, any studies with the product named VSL#3 prior to 2016 actually should be credited to Visbiome, and not VSL#3. Studies show that there are fundamental differences in both quantitative and performance characteristics in the two products. For more detailed information about the differences in formulations compared in a peer review journals, see the VSL#3 page.
At the time of this writing, Visbiome is available in three different products for humans and one for pets: (Please always check ingredients before purchasing or consuming as ingredients may change over time!)
Capsules in packs of 1, 2, or 4 bottles. These contain 112.5 billion CFU per capsule in 60-count bottles with microcrystalline cellulose, stearic acid, magnesium stearate, silicon dioxide, and vegetable capsule (hydroxypropyl methylcellulose) as the inactive ingredients.
Unflavored packets of 30 containing 450 billion CFU per packet. The only other ingredient is non-GMO cornstarch.
Extra-strength packets of 30 containing 900 billion CFU per packet dispensed by prescription only. Maltose and silicon dioxide are the other ingredients.
Visbiome Vet is a high potency probiotic formula used to support normal inflammatory responses in the GI tract and to help maintain gut health in dogs.
A 2018 study showed that it accelerated normalization of the intestinal microbiome in dogs with acute hemorrhagic diarrhea syndrome It is only dispensed by veterinarians and contains 112.5 billion CFU per capsule.
Please note that consumers are supposed to be working with a physician for treatment with irritable bowel syndrome (IBS), ulcerative colitis (UC), pouchitis, and hepatic encephalopathy (HE). Follow your doctor’s recommendations as to usage, but here are the guidelines from Visbiome for adults:
Here are the dosing recommendations from Visbiome for children:
Some research has shown that the gut "was fully colonized" in 20 days. Individual results may vary.
Visbiome is well-researched. There are advertised to be over 70 human clinical trials performed with it as a medical food in the dietary management of gastrointestinal and liver disorders, so trying to detail all of them would be a book in itself. In European studies the product is called Vivomixx, and in Korea it is known as the DeSimone Formulation.
Here is an overview of some of the results in adults:
Your local pharmacy may carry the non-prescription products.
You can also purchase the products from Amazon.com (which has multiple-package options, is shipped in the cooler with ice packs and the temperature monitor, and is sold by Visbiome there, NOT from resellers) or from the Visbiome website, which also has multiple-package options.
Obviously, the prescription product is only available with a prescription from your doctor.
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