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]

References

^ "De Simone v. VSL Pharms., Inc., Civil Action No. TDC-15-1356 | Casetext Search + Citator". casetext.com.
^ 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.{{cite journal}}: CS1 maint: unflagged free DOI (link)
^ 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.
^ 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.
^ 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.
^ 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.
^ 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.
^ 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.

[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.{{cite journal}}: CS1 maint: unflagged free DOI (link)

[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.

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