As clinical studies continue to validate the use of probiotics to help promote general gastrointestinal health, a growing U.S. market1 for probiotics indicates that the U.S. healthcare community and consumers alike are recognizing the value of these beneficial microorganisms. However, because most probiotics are classified as dietary supplements, directing patients to the best probiotic for their individual needs can be challenging. And, as the category matures, one probiotic preparation -- VSL#3 -- stands apart and ahead because it is not a supplement; it has been classified as a refrigerated medical food designated for the dietary management of three major gastrointestinal conditions: Ulcerative Colitis, Ileal Pouch and Irritable Bowel Syndrome (IBS).
The World Health Organization (WHO) defines probiotics as "live microorganisms which, when administered in adequate amounts confer a health benefit to the host." But research also shows that probiotics are not "one size fits all."
"As the amount of research in the field of probiotics increases, clinical evidence continues to indicate that not all probiotics are the same; probiotic activity is strain-specific and unique, and some strains can have antagonistic or synergistic activities when mixed together," said Marc Tewey, vice president, commercial operations, at Sigma-Tau Pharmaceuticals, Inc., manufacturer of VSL#3. "VSL#3 is formulated with a precise mix of eight proprietary strains of live bacteria, and the result is a probiotic medical food so potent, it must be used under medical supervision and must be shipped and sold as a refrigerated product."
What are medical foods?
According to the FDA, medical foods are:
- Specially formulated and processed products for the partial or exclusive feeding of a patient by means of oral intake or parenteral tube feeding
- For dietary management of patients with special medically determined nutrient requirements that cannot be achieved by diet alone
- Designed to provide nutritional support specifically modified for the management of the unique nutrient needs
- Only for use under medical supervision
- Only for a patient receiving active medical care on a recurring basis for the use of the medical food
"One of the main goals of physicians whose patients are living with these chronic diseases is to lengthen the periods between symptom 'flares' as much as possible," said Tewey. "Studies show that incorporating the use of this type of dietary therapy alongside traditional drug therapies can be an effective step in achieving that goal for many who suffer from these debilitating conditions."
VSL#3 is one of the few probiotic preparations supported by Level 1 (double-blind, placebo-controlled) scientific data, and has been the subject of a collection of more than 80 studies that have demonstrated its efficacy, specifically in the dietary management of IBS, Ulcerative Colitis and Ileal Pouch. It is the only probiotic recognized as an effective tool in the dietary management of pouchitis by the American College of Gastroenterology2 and by the Cochrane Review3 for the treatment and prevention of pouchtis after ileal pouch-anal anastamosis for chronic ulcerative colitis.