ExeGi Pharma, based in Gaithersburg, Maryland, recently announced the launch of Visbiome and Visbiome Extra Strength, the company’s new probiotic formulations for the dietary management of gastroenterological conditions such as ulcerative colitis, an inflammatory bowel disease (IBD).

Visbiome, a probiotic consisting of eight strains of live, freeze-dried lactic acid bacteria, includes the innovative blend that Prof. Claudio De Simone, M.D., Ph.D., developed – also known as the De Simone Formulation. It is therapeutically equivalent to the VSL#3 probiotic blend developed previously.

Visbiome is a clinical food prepared for medical purposes that delivers highly-concentrated anti-inflammatory probiotic bacteria in order to normalize the flora in the gut and provide considerable relief for a sustained period of time from gastroenterological symptoms, including irritable bowel syndrome (IBS), chronic pouchitis, and ulcerative colitis.

“Patients who are managing conditions like ulcerative colitis, pouchitis and IBS often face a roller-coaster ride of ups and downs,” Dr. Martin Floch, professor of medicine at Yale University and editor in chief of the Journal of Clinical Gastroenterology said in a press release. “In my clinical practice, I’ve seen first-hand how the De Simone Formulation has helped my patients achieve stability in their conditions. It’s so important that they can continue to access the formulation that we both trust and that’s yielded tangible results.”

De Simone first partnered with VSL Pharmaceuticals to develop and market his proprietary blend of probiotic strains, named VSL#3. Now, De Simone collaborates exclusively with ExeGi Pharma to produce Visbiome and Visbiome Extra Strength.

The De Simone Formulation is among the only blends of probiotics that has been assessed under rigorous, placebo-controlled, double-blind trials, and tested in more than 60 peer-reviewed scientific studies. Today, more than 20 trials worldwide continue to explore the potentials of the De Simone Formulation, and Visbiome will be subjected to a trial funded by the National Institute of Health’s National Institute of Allergy and Infectious Diseases (NIAID) to explore its therapeutic potential in HIV patients.

“More than 20 years ago, I created my probiotic formulation with the aim of helping patients manage complex conditions and support a healthy microbiome,” said De Simone, who is also ExeGi Pharma’s CMO. “The benefits of this formulation have been demonstrated in rigorous research again and again, and I am pleased to partner with ExeGi Pharma to ensure continued access to the probiotic blend that patients and their healthcare professionals trust.”

ExeGi Pharma has also developed significant product support features for the launch of Visbiome, such as:

• State of the art-packaged capsules called Active-Vials which ensure enhanced product potency and minimal moisture intrusion; and
• The ExeGi Direct Access reimbursement support phone line, to provide patients all the needed information regarding their insurance coverage for Visbiome Extra Strength.

Cleveland Clinic Foundation’s professor of molecular medicine, Dr. Claudio Fiocchi, who is also an international authority in the IBD field, said, “As an academic research gastroenterologist, it gives me a great deal of confidence knowing that patients will have access to such an extensively and rigorously tested product.

“Professor De Simone’s commitment to maintaining the integrity of his blend means that the known therapeutic effects of his original probiotic formulation will continue to be available to patients with a vast range of gastrointestinal ailments,” Fiocchi said.