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Stocking Up? Visbiome Lasts 24 Months Refrigerated Posted on March 25, 2020 14:43

COVID-19 continues to cause nationwide shutdowns and quarantines, and the timeline regarding a return to normalcy remains uncertain.

Because even one missed dose can disrupt daily life, many of our customers have been stocking up on Visbiome® to help them manage their dysbiosis related to digestive disorders such as IBS, Ulcerative Colitis, pouchitis, Hepatic Encephalopathy, and more.

Rest assured, in addition to being stable at room temperature for up to one week, Visbiome capsules and powder can be refrigerated for up to 24 months from the manufacturing date without affecting potency.

Ordering online is also convenient and safe. Have Visbiome shipped directly to your door – or check with your local pharmacy to see what shipping procedures are in place to accommodate patients at this time.

Our team is working overtime to ensure that our customers never run out of a product that they need. And we look forward to continuing to serve you once this crisis has passed.

Visbiome Readily Available in Midst of Virus Scare Posted on March 13, 2020 14:17

Over the past few weeks, it’s become clear that the world is facing an unprecedented challenge. As the Coronavirus (COVID-19) continues to affect our communities, ExeGi Pharma’s main priorities are looking after the health and safety of our employees, while providing the high-potency probiotic that so many of our customers rely on day to day.

On behalf of ExeGi Pharma, I wanted to send a personal note to reassure you that Visbiome will be available whenever you need it:

  • We have sufficient inventory. All of ExeGi Pharma’s manufacturers and distributors have been contacted and all vendors in our supply chain are up and running.
  • Ordering is convenient and safe. If you are you hesitant to venture to the pharmacy, you can Order Visbiome online and have it shipped directly to your door – or check with your local pharmacy regarding shipping procedures in place to accommodate patients during this time. Walgreens recently announced their stores will be waiving delivery fees for all eligible prescriptions.
  • Our products are made in the U.S.A., with no shipping limitations. Unlike other probiotics that are manufactured in overseas hotspots like China and Italy, Visbiome is manufactured locally. Products manufactured overseas are at higher risk of being disrupted by shipping limitations due to COVID-19. Shipments of Visbiome to our customers in need do not have the same risk.  

As the situation with Coronavirus continues to unfold, ExeGi Pharma and the Visbiome team are committed to continuous and efficient operation. Our teams are following all recommendations set forth by the Centers for Disease Control and the World Health Organization (WHO), while working overtime to ensure that our customers never run out of a product that they need.

Please feel free to reach out to us with any questions at (844) FIT-GUTS or And take care of yourself and your family!

Subscribe & Save to Stay Regular with Visbiome® Posted on September 16, 2019 13:36

Many people rely on high potency probiotics like Visbiome for digestive relief.

For individuals suffering from dysbiosis associated with digestive disorders like IBS, Ulcerative Colitis, pouchitis, and Hepatic Encephalopathy, even a single missed dose can disrupt daily life.

Now, Visbiome has introduced a better, easier way for its customers to stay current and compliant with their high potency probiotic regimens.

Our Subscribe & Save program allows customers to set up automatic shipments, ensuring that they never have to worry about remembering to place an order.

Customers can set and forget their subscriptions – which are available in 1, 2, or 3-month intervals – or can manage their ongoing subscriptions and individual upcoming orders directly from their account. Subscriptions can be canceled at any time.

The best part: enrolling in Subscribe & Save helps customers save, with 10% discounts on Visbiome Unflavored, our two-pack capsules, our four-pack capsules, and on the prescription-based Visbiome Extra Strength.

Customer service representatives are available to answer questions about Visbiome and its utility in managing dysbiosis associated with multiple digestive disorders. Contact us to learn more about how you can Subscribe & Save on Visbiome today.

Please note: Discount codes cannot be used with the Subscribe and Save program.

New Study Finds Multi-Strain Probiotic (De Simone Formulation) Aids Dietary Management of Cirrhosis Patients Posted on July 29, 2019 14:00

July 29, 2019 (Rockville, Maryland) – A new study published in the peer-reviewed journal Hepatology Communications finds that the multi-strain De Simone Formulation probiotic medical food may help in the dietary management of dysbiosis associated with cirrhosis by improving cognitive function, decreasing risk of falls, and improving inflammatory response. The De Simone formulation, which has been the subject of more than 70 clinical studies, is distributed in North America by Rockville, Maryland-based ExeGi Pharma under the brand name Visbiome®.

The double-blind placebo-controlled randomized trial, which was conducted by Román, Nieto, et al., included 36 patients studied between February 2013 and March 2016 and can be accessed at this link:

All patients were treated with sachets containing either the De Simone Formulation or a placebo for 12 weeks and assessed throughout the study for a battery of criteria including, among others, cognitive function, risk of falls, systemic inflammatory response, and biomarkers of intestinal barrier and bacterial translocation. Although previous studies have shown that probiotics can reduce systemic inflammation and the incidence of hepatic encephalopathy, while increasing liver function, cognitive function, and health-related quality of life, the effect of probiotics on the risk of falling in patients with cirrhosis had not been evaluated.

The study found statistically significant improvements in cognitive function as measured by the Psychometric Hepatic Encephalopathy Score (PHES). It also found statistically significant decreases in the risk of falls as measured by both the Timed Up & Go (TUG) test and gait speed. In addition to reducing the risk of falls, the study also showed an impressive decline in the incidence of falls in the study population with 0% of the De Simone patients falling and 22% of the placebo group patients falling during the study. Not surprisingly, since the probiotic patients had improved cognitive function and reduced risk of falling, the study also showed a trend toward improvement in social isolation.

The study’s authors regard the measured decrease in C-reactive protein among the probiotic patients as one of the most important outcomes of the study due to its role in reducing the proinflammatory state. They note that “systemic inflammation is related to neuroinflammation, which in turn is a main factor involved in the pathophysiology of covert and overt hepatic encephalopathy.”

“We continue to be heartened with each clinical trial that demonstrates the important effects of the De Simone Formulation and Visbiome. It’s been well known for decades to aid in the dietary management of pouchitis, IBS, and IBD, but the latest research shows its effects on broader systemic functions. Additional clinical trials are currently underway evaluating Visbiome in HIV prediabetes, depression, and Autism Spectrum Disorders. We can’t wait to hear the results”, said Marc Tewey, CEO of ExeGi Pharma.

About ExeGi Pharma 
ExeGi Pharma LLC is a biotechnology company focused on the development and commercialization of live biotherapeutic and probiotic medicines. ExeGi's team leverages scientific expertise in the field of microbiome science to deliver novel, clinically-supported live biotherapeutic and probiotic treatments for a variety of unmet medical needs. ExeGi is headquartered in Rockville, MD.

ExeGi Wins Court Ruling Against VSL#3®*, Permanent Injunction Blocks False Advertising To Doctors, Consumers Posted on June 25, 2019 08:59

Federal district court finds in favor of ExeGi and probiotic inventor, prohibits VSL#3 sellers from citing studies on original formulation

ROCKVILLE, Md., June 25, 2019 /PRNewswire/ -- ExeGi Pharma LLC is pleased to announce that on Friday, June 21, the United States District Court for the District of Maryland ruled in favor of a probiotic inventor and his business partner, ExeGi Pharma, LLC, in post-trial motions concerning the probiotic product VSL#3®. The ruling concludes over four years of litigation in which the inventor of the well-studied De Simone formulation probiotic (sold until July 2016 under the name VSL#3) sought to defend his ownership rights and prevent his former business partners from claiming that a reverse-engineered imitation product was, in fact, his own formulation.

On November 2018, a federal jury unanimously found in favor of the plaintiffs, inventor Professor Claudio De Simone and ExeGi, awarding over $18 million in damages for violations including false advertising under the Lanham Act. De Simone proved that, after leaving his long-term partnership with VSL Pharmaceuticals, VSL attempted and failed to reverse-engineer his formula. De Simone's original formulation had been studied extensively and established as a "medical food" for dietary management of serious gastrointestinal issues, such as ulcerative colitis and irritable bowel syndrome (IBS). VSL launched their version of VSL#3, an untested imitation product, without informing patients or physicians of the change.

Following the jury finding, the defendants (VSL Pharmaceuticals Inc., Leadiant Biosciences, and Alfasigma USA, Inc.) filed post-trial motions against key jury findings and requested a new trial. The Court denied each motion and affirmed that the original VSL#3 product containing De Simone's formulation was materially different from the imitation. The Court also found that, in marketing their product as the original, the defendants had advertised falsely with the intent to confuse or deceive the public.

Citing public health and wellbeing, the Court also issued a permanent injunction preventing the defendants from linking their product with the original De Simone formulation in other ways, including by citing clinical studies that were, in fact, performed only on the De Simone formulation. To date, more than 70 human clinical trials have been conducted on the original formulation, currently sold as VISBIOME®.

Marc Tewey, CEO of ExeGi, said: "We are very pleased with Friday's rulings. Ultimately, they will help protect the countless patients depending on VISBIOME® from further marketplace deception. We hope this sends a message to other probiotic manufacturers and resellers that not all probiotics are the same. Quality and testing matter when it comes to products with health implications and we will go to any lengths necessary to protect patient safety." 

About ExeGi Pharma 
ExeGi Pharma LLC is a biotechnology company focused on the development and commercialization of live biotherapeutic and probiotic medicines. ExeGi's team leverages scientific expertise in the field of microbiome science to deliver novel, clinically-supported live biotherapeutic and probiotic treatments for a variety of unmet medical needs. ExeGi is headquartered in Rockville, MD.

About Claudio De Simone 
Claudio De Simone, MD, PhD, is an internationally recognized scientific leader in the field of probiotics and the human gut microflora. Professor De Simone invented the formulation of the probiotic tested and currently sold under the name VISBIOME®, which has been the subject of more than 70 clinical trials and is used for the dietary management of pouchitis, IBD and IBS. In addition, Professor De Simone has authored over 200 published scientific articles, reviews, case reports and book chapters.

*VSL#3 is a registered trademark of VSL Pharmaceuticals Inc.


Importance of Cold Chain Shipping and Storage of Probiotics Posted on January 7, 2019 13:24

Should probiotics be shipped and stored cold- is this really necessary?

The use of probiotics in clinical settings is becoming increasingly common for a variety of medical conditions. If you use probiotics yourself, you may notice that most of the reputable probiotic products are found in the refrigerated section of your local health food or grocery store. Why, you may ask? The active component found within any probiotic is the actual living bacterial strain or strains. The secret many probiotic companies don’t like to discuss is that most probiotic bacteria will die if they are exposed to excessive heat. Even long-term exposure to room temperature conditions will adversely impact most probiotic strains.

The key to the beneficial impact of these products is that the bacteria need to be alive. It is for this reason that stores like Whole Foods have dedicated refrigerators just for their probiotic products.  

Many of the leading products on the market claim to be “shelf stable” at room temperature. The risk in taking probiotics stored at room temperature is that you will have no idea how the heat may have impacted the viability of the bacteria while on the shelf, or more importantly, during the shipping process. Even if your air-conditioned office is cool enough for storage of some probiotics, the temperatures associated with distribution and shipping these products to many areas throughout the country are likely to damage them.

Temperature exposure to packages sent by common carriers like UPS, FedEx, and the US Post Office will vary greatly depending on the time of year and geography. For example, a probiotic shipped by UPS in January from Detroit to Chicago is unlikely to be exposed to excessive heat in transit. However, a probiotic shipped during the summer months, or to southern parts of the country, is going to be much more at risk.

One study (Shallenberger, et al. 2015) analyzed the variable temperature exposure of certain medical packages shipped from Montana to six “warm climate” U.S. Cities (Phoenix, Tampa, New Orleans, Los Angeles, El Paso, Dallas) using variable shipping carriers and methods (2-day air, Next Day Air). Throughout August and September, three major U.S. carriers (FedEx, UPS, USPS) transported 72 individual shipments. The products were shipped without any form of insulation or cooling source[1].

The results showed that products shipped in warmer months, with no external cooling or insulation, will be exposed to high ambient temperatures. More relevant for the issue of shipping probiotics is that the data also show that packages were routinely exposed to temperature “spikes” when placed on planes or local delivery trucks. These temperatures spikes often exceeded 104°F (40°C), which are temperatures that will quickly kill even hearty probiotic bacteria. During the course of the study, the 72 packages recorded internal maximum temperatures ranging from a low of 76°F (24.6°C) to a high of 118°F (47.9°C). From this data, we can easily conclude that if probiotics are shipped without a cooling source and insulation, particularly in the warmer parts of the US, it is likely they will be compromised in shipping and rendered useless for the patient.

 How should probiotics be shipped and stored to ensure potency?

While there are dozens of probiotics products available in health stores and online, only a handful of products are actively being utilized in clinics.  The safest way to ensure that these products have not been compromised in the storage or transportation process is to choose a product which is stored and shipped under controlled, refrigerated conditions. When one considers the potential impact of temperature spikes during the shipping supply chain, the shipping issue should be of particular concern for those suffering from serious gastrointestinal disorders.

ExeGi Pharma is the maker of the Visbiome high potency probiotic, which is an 8-strain probiotic blend available in doses of 112.5, 450, and 900 billion live bacteria per dose. This product must be stored under refrigerated condition. ExeGi ships the Visbiome product via 2-Day Air express service using 1.5-inch-thick Styrofoam coolers with two frozen gel cold packs. The purpose of including insulation, cooling components, and express delivery with orders is to ensure that the product is not exposed to elevated temperature spikes of more than 86°F.

The Visbiome strains can be exposed to warm conditions for brief periods of time and are even stable at room temperature for up to a week. Unfortunately, temperature spikes above 86°F will begin to degrade the living bacteria, a phenomenon potentially present in competing products. As an added assurance of product integrity, ExeGi adds a WarmMark temperature monitoring device to every shipment. If the product is exposed to unacceptable temperature ranges, even for a short period of time, the monitor will be activated and turn red. In the unusual event that this occurs, the manufacturer will replace the product free of charge.  The inclusion of these temperature monitors is so important that, in addition to including these measures in their own shipment, the manufacturer also requires any third-party internet retailers of the product to use the devices, insulation, and gel packs in their shipping process.

In conclusion, probiotic bacteria are sensitive to heat, and reputable makers of human probiotics have shifted to a “Cold-Chain” storage and shipping method to protect their products before they are taken. Today, Visbiome is one of the major probiotic brands that is properly controlled for temperature exposure both during long term storage and shipping of the product. Ideally this will become industry standard, but for the meantime, it is crucial to be aware of which probiotics have their integrity protected from the heat and which do not. 


Key Takeaways

  • Probiotics should contain viable living bacteria in colony forming unit counts high enough to alter the gut flora.
  • Probiotic bacteria can be inactivated by excessive temperatures, which are common for packages delivered by major carriers such as FedEx, UPS and USPS.
  • Any probiotic product shipped via FedEx, UPS and USPS during the summer months to the southern part of the U.S. is likely to be exposed to temperature spikes which could inactivate probiotic bacteria
  • The Visbiome brand is shipped using insulated coolers, gel cold packs, standard 2-day express shipping, and temperature monitoring device to ensure product integrity.


For a printable version of this article, click here.


[1] Schallenerger, et al. The effect of temperature exposure during shipment on a commercially available demineralized bone matrix putty. Cell Tissue Bank (2016) 17:677-687

Maryland Federal Jury Unanimously Finds Probiotic Sellers Liable for False Advertising and Awards Product Inventor More than $18 Million in Damages Posted on November 26, 2018 10:26

Claudio De Simone, inventor of high-potency probiotic, sued pharmaceutical companies for making false advertising claims, ownership rights to the product formula and unpaid royalties

GREENBELT, Md. - A federal jury on Tuesday, Nov. 20, unanimously ruled in favor of a probiotic inventor who sued his former business partners after an international dispute concerning false advertising, ownership of a proprietary formulation and unpaid royalties. The inventor accused his former partners of attempting to make a copy of his invention and selling it to unsuspecting patients under the same brand name, even though the copy product had never been clinically tested.

The three-week trial in the U.S. District Court for the District of Maryland in Greenbelt included plaintiffs Professor Claudio De Simone and ExeGi Pharma LLC, of Rockville, Md., against defendants VSL Pharmaceuticals Inc., Leadiant Biosciences Inc. and Alfasigma USA Inc. The jury unanimously ruled that the pharmaceutical companies collectively owe the probiotic inventor, De Simone, more than $18 million in damages, including $15 million for defendant Alfasigma USA’s violation of the Lanham Act by deceiving patients, physicians and other stakeholders concerning the probiotic product they have been marketing since 2016.

De Simone successfully argued in court that VSL Pharmaceuticals had attempted to create a “knock-off” of De Simone’s product, even though they never had access to the propriety formula. They continued to call this knock-off by its original brand name, “VSL#3®”, a trademark owned by VSL Pharmaceuticals Inc., and continued to reference the extensive clinical research on the product proving the product was efficacious and safe, even though they never fully tested the copy product. During the trial, De Simone was able to prove that the defendants’ copy product was not the same as De Simone’s original invention and had never been tested in humans to ensure that it performs the same way as the original formula. De Simone is currently partnered with co-plaintiff ExeGi Pharma to sell the formulation under the brand name Visbiome®.

Prof. De Simone and ExeGi were represented in the case by Jeremy W. Schulman of the law firm Schulman Bhattacharya, LLC.

“We are proud that we’re protecting the life’s work of a brilliant scientist, Prof. Claudio De Simone, who is responsible for helping thousands of patients worldwide to live better lives by managing their serious medical conditions through the invention of a superior, high-potency probiotic product,” Schulman said.

De Simone commented: “I am grateful that the jury saw through the falsehoods of the defendants and ruled in our favor. I created the probiotic product to help patients who had suffered for years with gastrointestinal illnesses and diseases. I never imagined that a multi-national pharmaceutical company and the other defendants would attempt to steal my invention and then pass off an inferior and fake product as mine. Now I will turn my attention to supporting patients in Europe, Asia and other parts of the world who are at risk of being similarly misled.”


ExeGi Media:
Andrea Fetchko

Michael O’Brien

Visbiome® Vet probiotic to be the subject of two new clinical trials in domestic dogs Posted on September 12, 2018 07:00

Visbiome® Vet probiotic to be the subject of two new clinical trials in domestic dogs

Rockville, Md., September 12th, 2018 –ExeGi Pharma is pleased to announce two new clinical partnerships with the College of Veterinary Medicine at the University of Georgia and the University of Tennessee to study the Visbiome Vet probiotic in domestic dogs. Both studies will evaluate the probiotic’s effectiveness in managing canine gastrointestinal disorders. Visbiome Vet is an 8-strain probiotic compound with an extremely high concentration of beneficial bacteria (112.5 billion bacteria per dose). The formulation in Visbiome Vet is one of the most extensively studied probiotic products for pets, as it has been the subject of four controlled clinical trials.

The University of Georgia will research and evaluate effects of the product on diarrhea levels in dogs post-surgery. Diarrhea is a common occurrence in dogs following surgical procedures and anesthesia. This placebo-controlled study will evaluate the incidence and severity of diarrhea, as well as changes to the canine microbiome.

The second study will be conducted by the University of Tennessee Institute of Agriculture. The research will evaluate reduction of severe diarrhea in canine acute gastroenteritis after consumption of Visbiome Vet. This placebo-controlled study will compare the safety and efficacy of Visbiome Vet to dietary changes with a specifically formulated medical diet, or antibiotics (metronidazole). 

Pets, like humans, are host to a complex ecological community consisting of trillions of microorganisms. This bacterial community, which is commonly referred to as the microbiome, consist of good and bad bacteria that live on and in the body. Good bacteria exist in a beneficial and symbiotic relationship with the host. In recent years, scientists have come to a better understanding of how alterations in the gut microbiome can impact certain diseases. Visbiome Vet beneficially alters the gut microbiome of companion animals by introducing a high concentration of helpful bacteria to help normalize some forms of gastrointestinal disorders. While antibiotics are commonly used today to treat diarrhea, these treatments may lead to long term antibiotics resistance.

Many researchers and doctors are now advocating for the supplementation of probiotics. Veterinarians are also supporting the use of probiotics in animals. “Gastrointestinal disorders are a common cause for pet owners to seek the medical care of a veterinarian,” said Dr Al Jergens, DVM, PhD.  “Modulating the gut microbiome with high potency probiotics may prove to be a valuable tool to help these pets manage clinical signs of GI disease, including diarrhea.” 

Visbiome® Vet is available exclusively through veterinarians and veterinary pharmacies.

About Visbiome® Vet

Visbiome® Vet is a new high potency probiotic for use in companion dogs to help support normal inflammatory responses in the gastrointestinal tract (GI tract) and to help normalize gut health.

The formulation in Visbiome Vet contains an eight-strain proprietary probiotic blend that has recently been studied in several canine GI disorders. Visbiome Vet is the identical formulation to Visbiome®, a human medical food that has been the subject of over 60 clinical trials.

About ExeGi Pharma
ExeGi Pharma, LLC is a biotechnology company focused on the development and commercialization of live biotherapeutic and probiotic medicines. ExeGi’s team leverages the growing advances in the field of microbiome science to deliver novel clinically supported live biotherapeutic and probiotic treatments for a wide variety of unmet medical needs.



Clinical studies show probiotic used to manage human GI disorders can help support bowel and gut health in dogs

ROCKVILLE, MD - ExeGi Pharma LLC, a company focused on developing and commercializing live biotherapeutics and probiotic treatments, announced today that it has launched Visbiome ® Vet, a new high potency probiotic for use in companion dogs to help support normal inflammatory responses in the gastrointestinal tract (GI tract) and to help normalize gut health.  

The formulation in Visbiome Vet contains an eight-strain proprietary probiotic blend that has recently been studied in several canine GI disorders, with two clinical trials published in the last 12 months. Visbiome Vet is the identical formulation to Visbiome®, a human medical food that has been the subject of over 60 clinical trials.

“Serious gastrointestinal conditions in dogs is often linked to alterations in the GI bacterial community, commonly known as the gut microbiome,” said Dr. Jan Suchodolski, PhD, DACVM at Texas A&M University. “This formulation has been shown in a variety of trials to help normalize gut health.”

Visbiome Vet contains 112.5 billion live bacteria per dosage, a potency that far exceeds other conventional veterinary probiotics. The product, only available to veterinarians and veterinary pharmacies, is packaged conveniently for veterinary applications. Visbiome Vet is shipped and stored only under refrigerated conditions to ensure maximum product potency.

“Over the last year we have been overwhelmed by pet owners telling us about the tremendous results they were experiencing using our human Visbiome product with their pets,” said Marc Tewey, CEO of ExeGi Pharma. “We are pleased to finally bring this high potency probiotic formulation to the veterinary community with Visbiome Vet.” 

Visbiome Vet is available exclusively to veterinarians and veterinary pharmacies. For more information, please visit or

About ExeGi Pharma
ExeGi Pharma LLC, is a biotechnology company focused on the development and commercialization of live biotherapeutic and probiotic medicines. ExeGi’s team leverages scientific expertise in the field of microbiome science to deliver novel, clinically-supported live biotherapeutic and probiotic treatments for a variety of unmet medical needs. ExeGi is headquartered in Rockville, MD.

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Visbiome Probiotic May Play a Role in Recovery of GI Functions in HIV Patients Posted on May 4, 2017 16:48

ROCKVILLE, Md.--()--A newly released study published in the Journal of Immunity, Inflammation and Disease and conducted by the Sapienza University of Rome, Italy, found a multi-strain, high concentration, probiotic formulation that helped reconstitute the physical and immunological integrity of the gastrointestinal lining in HIV-1-positive patients on antiretroviral therapy (ART).

The human gastrointestinal (GI) tract is home to trillions of organisms which form a complex bacterial community, commonly referred to as the “gut microbiome.” A key function of the GI tract is to separate these bacteria from internal organs with a single layer of intestinal cells, called epithelial cells. The epithelial cells form a physical and immunological barrier to prevent entry of gut bacteria into the bloodstream. When this barrier breaks down, or becomes compromised, it can result in a dangerous circulation of bacteria throughout the body.

In patients with HIV, this “barrier function” of the GI tract is damaged by the virus starting very early after viral acquisition. Even when the disease is treated with antiretroviral therapy, the integrity of the GI tract often remains severely compromised. This lack of a proper barrier can result in a low-grade, long-term, systemic immune activation and inflammation which is commonly associated with a variety of HIV-related comorbidities, such as cardiovascular disease, kidney disease, diabetes, and bone fracture.1, 2

Probiotic bacteria have been shown to help support this barrier function through a variety of mechanisms, including the competitive exclusion of damaging bacteria and the release of bioactive compounds, such as butyrate, which help tighten the junctions between the epithelial cells. In this longitudinal pilot study, a high potency, eight strain probiotic formulation (commercialized as VisbiomeTM in the United States and VivomixxTM in Europe) was evaluated in long-term treated HIV-positive patients on ART to determine the product’s safety and impact on gut barrier function. The investigators observed several clinical and biochemical indicators, which showed an improvement in the integrity of the gastrointestinal epithelial cell wall and an overall reduction in damaging systemic inflammation.

“We believe this is the first time a probiotic has been shown to clearly improve the integrity of the GI epithelial cell wall in HIV patients,” said Dr. Giancarlo Ceccarelli M.D., Ph.D., a clinical researcher and HIV treatment specialist at the Sapienza University of Rome who actively conducted the study. “There appear to be multiple therapeutic mechanisms at work, but the improvement in Th17 immune cells in the GI tissue was of particular interest. In the HIV population, a depletion of Th17 in the gastrointestinal tract is common and is a significant driver of the loss of intestinal barrier function.”

There were no adverse safety-related findings associated with VisbiomeTM. The investigators also cautioned against broadly translating this research to all probiotic products, noting that the clinical findings for probiotics should only be applied to the specific strains evaluated, particularly when dealing with an immunocompromised patient population.

Two large studies are currently underway in the United States and Canada to further evaluate the impact of Visbiome in HIV. A multi-center study, being conducted by the NIH funded AIDS Clinical Trials Group (ACTG), is seeking to determine if the product can reduce damaging systemic inflammation in HIV patients in comparison to placebo. Results of this study are expected in early 2018.

To learn more about these trials, please visit A full copy of this study can be found at

For information about Visbiome in the United States, please visit For information about Vivomixx in Europe, please visit

About Visbiome™
Visbiome™ is a high potency probiotic medical food consisting of eight strains of live, freeze-dried lactic acid bacteria. Visbiome is specially formulated for the dietary management of dysbiosis associated with IBS, ulcerative colitis, pouchitis, and hepatic encephalopathy. Visbiome is a non-drug therapy that addresses distinct nutritional requirements, to promote microbial balance, in people with IBS, ulcerative colitis, pouchitis, and hepatic encephalopathy that cannot be addressed by modification of the diet alone. Visbiome is currently the subject of eight clinical trials, as a medical food, in several new disease states including HIV, autism spectrum disorders, and liver cirrhosis. Visbiome is intended to be used under the supervision of a physician.

About ExeGi Pharma
ExeGi Pharma, LLC is a biotechnology company focused on the development and commercialization of live biotherapeutic and probiotic medicines. ExeGi's team leverages the growing advances in the field of microbiome science to deliver novel clinically supported live biotherapeutic and probiotic treatments for a wide variety of unmet medical needs.

1 Guaraldi G, Orlando G, Zona S, et al. Premature age-related comorbidities among HIV-infected persons compared with the general population. Clinical infectious diseases : an official publication of the Infectious Diseases Society of America. 2011; 53(11):1120–1126.

2 Marchetti G, Tincati C, Silvestri G. Microbial translocation in the pathogenesis of HIV infection and AIDS. Clinical Microbiology Reviews. 2013; 26(1):2–18.


ExeGi Pharma, LLC
Vanita Patel, 240-428-6891

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