De Simone Formulation

The De Simone Formulation is a probiotic formula and manufacturing method developed by medical doctor Professor Claudio De Simone (MD, FAGA).[1]

The De Simone Formulation has been clinically studied for a variety of health conditions since the 1990s[2] but it has been researched the most for its efficacy in the medical management of chronic intestinal conditions including irritable bowel syndrome (IBS)[3][4] and inflammatory bowel disease (IBD)[5][6][7][8]

The probiotic formulation is classed as a high potency probiotic medical food in the United States.[9] It is intended for the dietary management of dysbiosis (microbiota imbalance)[10] associated with irritable bowel syndrome (IBS),[11] antibiotic-associated diarrhea,[12] ulcerative colitis (UC),[13][14] pouchitis,[15] hepatic encephalopathy (HE),[16] pregnancy,[17] for babies born by Caesarean Section (C-section),[18] and for babies that are bottle-fed[19]

History

Professor De Simone first patented the De Simone Formulation with the United States Patent and Trademark Office on February 10, 1998, under number 5,716,615.[20]

The pharmaceutical distribution company, VSL Pharmaceuticals, Inc., later assigned the trademarked brand name VSL#3 to Professor De Simone's probiotic formulation. The patent was re-issued on January 22, 2008, with Claudio De Simone as the sole inventor of the formulation sold at the time under the brand name VSL#3.[21]

The De Simone Formulation was sold to consumers under the brand name VSL#3 from 2002 through May 2016.[22][23] Since May 2016 the De Simone Formulation is no longer in the probiotic being sold under the brand name VSL#3.[24]

North American distribution changed to ExeGi Pharma in 2016[25] and European distribution has been conducted by Mendes SA since 2015.[26] The De Simone Formulation is sold under a number of different regional brand names including Visbiome in the United States and Canada and as Vivomixx in Europe including the United Kingdom.

Prior to May 2016, the De Simone Formulation selling under the brand name VSL#3, was researched in more than 70 human clinical trials. This pre-May 2016 clinical research using the De Simone Formulation has been published and referenced in hundreds of peer-reviewed medical and scientific journals under the name VSL#3.[27]

All research on the De Simone Formulation since May 2016 is cited under either the De Simone Formulation reference or it is affiliated with various regional brand names.[28][29]

Lawsuits

The De Simone Formulation has been the subject of lawsuits. In the United States, the 4th U.S. Circuit Court of Appeals upheld a false advertising verdict against the makers of the VSL#3 probiotic in February 2021 stating there was enough evidence to support a jury's November 2018 finding that the makers of VSL#3 had quote "reverse-engineered an imperfect copy" of De Simone's signature probiotic formulation that was sold under the brand name VSL#3 through May 2016 after he withdrew from their joint venture, VSL Pharmaceuticals Inc. According to the lawsuit, his departure was as a result of being pressured to substitute cheaper bacteria in the manufacturing process to lower production costs and raise profits. Court action states that Professor De Simone apparently refused.[30] The makers of VSL#3 were ordered to pay Professor De Simone and ExeGi Pharma a combined total of $18 million (USD) in damages.[31][32][22]

The Court also issued a permanent injunction intended to prevent claims, implied or stated, of continuity between the two different formulations. The court also cited public health and wellbeing concerns, when they blocked the makers of VSL#3 from linking their product with the original De Simone Formulation by referring to clinical studies that were executed using the De Simone Formulation prior to May 2016.[33]

On August 1, 2019, the American Gastroenterology Association (AGA), the medical association of gastroenterologists in the United States, issued a correction regarding the De Simone Formulation and VSL#3. AGA's correction stated it had referenced studies referenced in its 2019 Technical Review on the Management of Mild-to-Moderate Ulcerative Colitis that were based on the probiotic formulation previously know by the brand name VSL#3 before May 2016, but was now known by the formulation name 'De Simone Formulation'.[24][34]

On January 24, 2022, the European Crohn's and Colitis Organization (ECCO) issued a letter to the editor of Oxford Academic's Journal of Crohn's and Colitis (JCC) stating that as a result of a court injunction, the ECCO must provide a clarification note for changes relating to VSL#3 and the De Simone Formulation in their articles that reference or studied these probiotics.[35]

Claudio De Simone

The probiotic formulation's inventor, Professor Claudio De Simone, is an internationally recognized European academic in the field of probiotics and the human microbiota. He is a member of the American College of Gastroenterology. He is also a retired Professor of Infectious Diseases at the University of L'Aquila (Italy), where he specialized in gastroenterology, allergology, and clinical immunology. [36] Professor De Simone graduated from the University of Rome with the distinction of Summa Cum Laude for medicine and surgery in 1975. He also earned specialized medical degrees in both Gastroenterology and Immunology.[37]

Professor De Simone has researched the human microbiome for decades. His interested in the human intestinal microbiota stems back to when the understanding of the importance of the role of the intestinal flora was just beginning. Since commercializing his De Simone Formulation, the Professor has actively campaigned for better regulation and quality control of probiotics based on potential risks to health and wellbeing.[38]

The Professor developed the probiotic formulation known as the 'De Simone Formulation' in the 1990s. It is a mix of eight high concentration bacterial strains in a specific ratio.[39] He has authored more than 200 published case studies, scientific articles, and book chapters.[40][41]

See also

References
  1. "De Simone v. VSL Pharms., Inc., Civil Action No. TDC-15-1356 | Casetext Search + Citator". casetext.com.
  2. Cheng, F. S.; Pan, D.; Chang, B.; Jiang, M.; Sang, L. X. (2020). "Probiotic mixture VSL#3: An overview of basic and clinical studies in chronic diseases - PMC". World Journal of Clinical Cases. 8 (8): 1361–1384. doi:10.12998/wjcc.v8.i8.1361. PMC 7190945. PMID 32368530.
  3. Almerigi, Pier Francesco; Menarini, Mauro; Bazzocchi, Gabriele (July 17, 2010). Santoro, Giulio Aniello; Wieczorek, Andrzej Paweł; Bartram, Clive I. (eds.). Pelvic Floor Disorders: Imaging and Multidisciplinary Approach to Management. Springer Milan. pp. 539–543. doi:10.1007/978-88-470-1542-5_74.
  4. Kim, J.; Cho, K.; Kim, J. S.; Jung, H. C.; Kim, B.; Park, M. S.; Ji, G. E.; Cho, J. Y.; Hong, K. S. (2019). "Probiotic treatment induced change of inflammation related metabolites in IBS-D patients/double-blind, randomized, placebo-controlled trial - PMC". Food Science and Biotechnology. 29 (6): 837–844. doi:10.1007/s10068-019-00717-2. PMC 7256134. PMID 32523793.
  5. Lichtenstein, L.; Avni, I.; Ben-Bassat, O. (February 1, 2017). "P478 The current place of probiotics in treatment of pouchitis: systematic review". Journal of Crohn's and Colitis. 11 (suppl_1): S321–S322. doi:10.1093/ecco-jcc/jjx002.602.
  6. Fedorak, Richard N.; Feagan, Brian G.; Hotte, Naomi; Leddin, Des; Dieleman, Levinus A.; Petrunia, Denis M.; Enns, Robert; Bitton, Alain; Chiba, Naoki; Paré, Pierre; Rostom, Alaa; Marshall, John; Depew, William; Bernstein, Charles N.; Panaccione, Remo; Aumais, Guy; Steinhart, A. Hillary; Cockeram, Alan; Bailey, Robert J.; Gionchetti, Paolo; Wong, Cindy; Madsen, Karen (May 17, 2015). "The probiotic VSL#3 has anti-inflammatory effects and could reduce endoscopic recurrence after surgery for Crohn's disease". Clinical Gastroenterology and Hepatology. 13 (5): 928–935.e2. doi:10.1016/j.cgh.2014.10.031. PMID 25460016.
  7. Rohatgi, Sarika; Ahuja, Vineet; Makharia, Govind K.; Rai, Tarun; Das, Prasenjit; Dattagupta, Siddharth; Mishra, Veena; Garg, Sushil Kumar (December 31, 2015). "VSL#3 induces and maintains short-term clinical response in patients with active microscopic colitis: a two-phase randomised clinical trial". BMJ Open Gastroenterology. 2 (1): e000018. doi:10.1136/bmjgast-2014-000018. PMC 4599154. PMID 26462271. S2CID 16306599.
  8. Karimi, Ouafae; Peña, A. Salvador; van Bodegraven, Adriaan A. (July 17, 2005). "Probiotics (VSL#3) in arthralgia in patients with ulcerative colitis and Crohn's disease: a pilot study". Drugs of Today (Barcelona, Spain: 1998). 41 (7): 453–459. doi:10.1358/dot.2005.41.7.917341. PMID 16193098.
  9. Nutrition, Center for Food Safety and Applied (January 25, 2022). "Medical Foods Guidance Documents & Regulatory Information". FDA.
  10. "Probiotics: A Review for Clinical Use". Gastroendonews.com. Retrieved July 18, 2022.
  11. Guandalini, Stefano; Magazzù, Giuseppe; Chiaro, Andrea; La Balestra, Valeria; Di Nardo, Giovanni; Gopalan, Sarath; Sibal, A.; Romano, Claudio; Canani, Roberto Berni; Lionetti, Paolo; Setty, Mala (July 17, 2010). "VSL#3 Improves Symptoms in Children With Irritable Bowel Syndrome: A Multicenter, Randomized, Placebo-Controlled, Double-Blind, Crossover Study". Journal of Pediatric Gastroenterology and Nutrition. 51 (1): 24–30. doi:10.1097/MPG.0b013e3181ca4d95. PMID 20453678. S2CID 33659736.
  12. Selinger, C. P.; Bell, A.; Cairns, A.; Lockett, M.; Sebastian, S.; Haslam, N. (June 17, 2013). "Probiotic VSL#3 prevents antibiotic-associated diarrhoea in a double-blind, randomized, placebo-controlled clinical trial". The Journal of Hospital Infection. 84 (2): 159–165. doi:10.1016/j.jhin.2013.02.019. PMID 23618760.
  13. Arthur, Janelle C.; Gharaibeh, Raad Z.; Uronis, Joshua M.; Perez-Chanona, Ernesto; Sha, Wei; Tomkovich, Sarah; Mühlbauer, Marcus; Fodor, Anthony A.; Jobin, Christian (October 8, 2013). "VSL#3 probiotic modifies mucosal microbial composition but does not reduce colitis-associated colorectal cancer". Scientific Reports. 3 (1): 2868. Bibcode:2013NatSR...3E2868A. doi:10.1038/srep02868. PMC 3792409. PMID 24100376.
  14. Tursi, A.; Brandimarte, G.; Papa, A.; Giglio, A.; Elisei, W.; Giorgetti, G. M.; Forti, G.; Morini, S.; Hassan, C.; Pistoia, M. A.; Modeo, M. E.; Rodino', S.; d'Amico, T.; Sebkova, L.; Sacca', N.; Di Giulio, E.; Luzza, F.; Imeneo, M.; Larussa, T.; Di Rosa, S.; Annese, V.; Danese, S.; Gasbarrini, A. (2010). "Treatment of Relapsing Mild-to-Moderate Ulcerative Colitis With the Probiotic VSL#3 as Adjunctive to a Standard Pharmaceutical Treatment: A Double-Blind, Randomized, Placebo-Controlled Study - PMC". The American Journal of Gastroenterology. 105 (10): 2218–2227. doi:10.1038/ajg.2010.218. PMC 3180711. PMID 20517305.
  15. "UpToDate". Uptodate.com.
  16. Dhiman, Radha K.; Rana, Baldev; Agrawal, Swastik; Garg, Ashish; Chopra, Madhu; Thumburu, Kiran K.; Khattri, Amit; Malhotra, Samir; Duseja, Ajay; Chawla, Yogesh K. (December 17, 2014). "Probiotic VSL#3 reduces liver disease severity and hospitalization in patients with cirrhosis: a randomized, controlled trial". Gastroenterology. 147 (6): 1327–1337.e3. doi:10.1053/j.gastro.2014.08.031. PMID 25450083.
  17. Baldassarre, M. E.; Di Mauro, A.; Mastromarino, P.; Fanelli, M.; Martinelli, D.; Urbano, F.; Capobianco, D.; Laforgia, N. (2016). "Administration of a Multi-Strain Probiotic Product to Women in the Perinatal Period Differentially Affects the Breast Milk Cytokine Profile and May Have Beneficial Effects on Neonatal Gastrointestinal Functional Symptoms. A Randomized Clinical Trial - PMC". Nutrients. 8 (11): 677. doi:10.3390/nu8110677. PMC 5133065. PMID 27801789.
  18. "Probiotics could give cesarean section babies a healthier start". Scienceline.org. 20 February 2019.
  19. "Probiotics in Infant Formula". Healthychidren.org.
  20. "United States Patent: 5716615 - Dietary and pharmaceutical compositions containing lyophilized lactic bacteria, their preparation and use". Patft.uspto.gov.
  21. "United States Patent: RE40023 - Dietary and pharmaceutical compositions containing lyophilized lactic bacteria, their preparation and use". Patft.uspto.gov.
  22. "This case involved a dispute between former business partners as to the ownership of a proprietary formulation ("the De Simone Formulation") used in a probiotic previously known by the tradename VSL#3 and now known by the tradename Visbiome. In November 2018, a jury returned a verdict in favor of Plaintiff and Counterclaim Defendant Claudio DeSimone and Plaintiff ExeGi Pharma, LLC ("ExeGi") (collectively, "the De Simone Parties") on all counts against Defendant and Counterclaim Plaintiff VSL Pharmaceuticals, Inc. ("VSL"), Defendant Leadiant Biosciences, Inc. ("Leadiant") and Defendant Alfasigma USA, Inc. ("Alfasigma")" (PDF). Govinfo.gov. Retrieved July 18, 2022.
  23. "The case arises out of Defendants' false advertising of VSL#3 during the Class Period" (PDF). Classaction.org. Retrieved July 18, 2022.
  24. "Correction". Gastroenterology. 157 (3): 903. September 1, 2019. doi:10.1053/j.gastro.2019.07.035. PMID 31377277. S2CID 241186727.
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  28. De Simone, C (February 1, 2018). "P884 No shared mechanisms among "old" and "new" VSL#3: Implications for claims and guidelines". Journal of Crohn's and Colitis. 12 (supplement_1): S564–S565. doi:10.1093/ecco-jcc/jjx180.1011.
  29. "Study of the Effect of VSL#3 (Original De Simone Formulation) on Cognitive Function, Risk of Falls and Quality of Life in Patients With Cirrhosis". May 18, 2016.
  30. "Class Action Accuses Pharma Companies of Secretly Reformulating VSL#3 Probiotics Product". Classaction.org. 26 July 2019.
  31. "IN BRIEF: Supplement makers owe $18 mln for marketing copy as original – 4th Circuit". Reuters.com. February 18, 2021.
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  33. "ExeGi Wins Court Ruling Against VSL#3®*, Permanent Injunction Blocks False Advertising To Doctors, Consumers". BioSpace.com.
  34. Singh, Siddharth; Feuerstein, Joseph D.; Binion, David G.; Tremaine, William J. (February 12, 2019). "AGA Technical Review on the Management of Mild-to-Moderate Ulcerative Colitis". Gastroenterology. 156 (3): 769–808.e29. doi:10.1053/j.gastro.2018.12.008. PMC 6858923. PMID 30576642.
  35. Peyrin-Biroulet, Laurent; Siegmund, Britta; Danese, Silvio; Hart, Ailsa; Magro, Fernando; Van Der Woude, Janneke; Armuzzi, Alessandro (January 24, 2022). "Letter to the Editor". Journal of Crohn's and Colitis: jjab225. doi:10.1093/ecco-jcc/jjab225. PMID 35073577.
  36. "Trademarks, branding and product names: An 'unregulated' part of the probiotic market?". Nutraingredients.com.
  37. "Hyphens Pharma Advances Discussion on Benefits of High Potency Live Bacteria". 28 September 2011.
  38. Simone, Claudio de (April 1, 2019). "The Unregulated Probiotic Market". Clinical Gastroenterology and Hepatology. 17 (5): 809–817. doi:10.1016/j.cgh.2018.01.018. PMID 29378309.
  39. MSc, Margarida Azevedo. "Dietary Management of Ulcerative Colitis, Gastroenterological Conditions Aided With New Probiotic". Ibdnewstoday.com.
  40. "ExeGi Wins Court Ruling Against VSL#3®*, Permanent Injunction Blocks False Advertising to Doctors, Consumers".
  41. "ExeGi Pharma Secures License for Well-Studied Probiotic".
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