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(12) United States Patent (10) Patent No.: US 9,138,441 B2 Trachtman (45) Date of Patent: Sep

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(12) United States Patent (10) Patent No.: US 9,138,441 B2 Trachtman (45) Date of Patent: Sep US009 138441B2 (12) United States Patent (10) Patent No.: US 9,138,441 B2 Trachtman (45) Date of Patent: Sep. 22, 2015 (54) COMPOSITIONS AND METHOD FOR FOREIGN PATENT DOCUMENTS TREATMENT AND PROPHYLAXIS OF WO 20040069156 A2 8, 2004 NFLAMMLATORY BOWEL DISEASE WO WO 2007036230 A1 * 4, 2007 WO 20090.134948 A1 11, 2009 (76) Inventor: Ira Milton Trachtman, New York, NY WO 20090158384 A1 12/2009 (US) WO 20110822.18 A1 T 2011 (*) Notice: Subject to any disclaimer, the term of this OTHER PUBLICATIONS patent is extended or adjusted under 35 University of Maryland Medical Center, “Crohn's disease”. (http:// U.S.C. 154(b) by 0 days. umm.edu/Health/Medical/Ency/Articles/Crohns-disease>, updated Appl. No.: 13/517,486 Sep. 18, 2013, p. 1-7.* (21) University of Maryland Medical Center, “Ulcerative colitis'. <http:// umm.edu/health/medical/ency/articles/ulcerative-colitis, updated (22) PCT Fled: Dec. 29, 2010 Sep. 18, 2013, p. 1-6.* Dubinsky, MC., “AZathioprine, 6-mercaptopurine in inflammatory (86) PCT NO.: PCT/US2O10/062339 bowel disease: pharmacology, efficacy, and safety (Abstract). Clin S371 (c)(1), Gastroenterol Hepatol. Sep. 2004; 2(9): p. 731-743.* Ecology Health Center, "Fatty Acids for the Treatment of Crohn's (2), (4) Date: Jun. 20, 2012 Disease”. (http://www.crohns.net/Miva education/articles/Fatty Acids for the Treatment of Crohns Disease.shtml>, pub (87) PCT Pub. No.: WO2O11AO82218 lished Feb. 9, 2005, p. 1-2.* PCT Pub. Date: Jul. 7, 2011 Sheil B. et al., “Probiotic Effects on Inflammatory Bowel Disease.” J. Nutr. 137, 2007, p. 81.9S-824S.* Prior Publication Data Lal, S. et al., “Antibiotic therapy for Crohn's disease: A review.” Can (65) J. Gastroenterol, vol. 20, No. 10, Oct. 2006, p. 651-655.* US 2012/O2762O1 A1 Nov. 1, 2012 Lee et al., “Pneumocystis Jirovecii Pneumonia and Pneumomediastinum in an Anti-TNFalpha Naive Patient with Ulcer ative Colitis.” World Journal of Gastroenterology, vol. 15, No. 15, pp. Related U.S. Application Data 1897-1900, Apr. 2009. International Search Report and Written Opinion dated Jan. 3, 2014, (60) Provisional application No. 61/291,474, filed on Dec. which issued in corresponding International Application No. PCT/ 31, 2009. US2013/049596. Campieri Massimo et al.: "Combination of antibiotic and probiotic (51) Int. C. treatment is efficacious in prophylaxis of post-operative recurrence of Crohn's disease: A Randomized controlled study vs. mesalamine”. A6 IK3I/63 (2006.01) Gastroenterology; 101st annual meeting of the American A6 IK 45/06 (2006.01) Gastroenterological Associate and the Digestive Disease Week, San A6 IK35/74 (2015.01) Diego, CA, US; May 21-24, 2000, Elsevier, Philadelphia, PA. vol. A6 IK35/742 (2015.01) 118, No. 4 part 1, pp. AGAA781 (2000). A 6LX 35/745 (2015.01) Danzi JT: “Trimethoprim-Sulfamethoxazole in the Therapy of A 6LX 35/747 (2015.01) Severe Ulcerative Colitis and Crohn;s Disease'. American Journal of A 6LX3L/505 (2006.01) Gastroenterology, vol. 82, No. 9, pp. 960 (1987). A6 IK9/24 (2006.01) (Continued) (52) U.S. C. CPC ................. A61 K3I/63 (2013.01); A61 K9/209 (2013.01); A61 K3I/505 (2013.01); A61 K Primary Examiner — Tracy Vivlemore 35/745 (2013.01); A61 K35/747 (2013.01); Assistant Examiner — Monica Shin A61K 45/06 (2013.01) (74) Attorney, Agent, or Firm — Greenberg Traurig, (58) Field of Classification Search Jonathan D. Ball None See application file for complete search history. (57) ABSTRACT (56) References Cited Methods and compositions for treating inflammatory bowel U.S. PATENT DOCUMENTS disease involve the use of targeted antibiotics in combination with probiotic formulations. The probiotics mitigate many of 6.479,051 B1 1 1/2002 Bruce et al. the deleterious side effects associated with antibiotic use and 7,018,629 B2 3, 2006 Jacob et al. 2003, OO31659 A1 2/2003 Farmer permit the antibiotic to be administered at a higher dose and 2007/0060552 A1* 3, 2007 Ekwurbe et al. ............. 514,150 for a longer duration than would otherwise be possible in the 2007/O160589 A1 7/2007 Mattson et al. absence of the probiotic. The practice of the invention may 2007/0173462 A1 7/2007 Shue et al. 2007/0298018 A1 12/2007 Bojrab et al. reduce or eliminate the use of immunosuppressants in the 2009/0098088 A1 4/2009 Taylor et al. treatment and management of IBD. 2011/0240512 A1* 10, 2011 Dorfner ........................ 206,532 2012fO214822 A1 8/2012 Brough et al. 2012fO214833 A1 8/2012 Kulkarni et al. 33 Claims, No Drawings US 9,138.441 B2 Page 2 (56) References Cited Rizzello F. et al.: “Prophylaxis of postoperative recurrence of Crohn's disease: Combination of antibiotic and probiotic versus OTHER PUBLICATIONS mesalamine”. Digestive and Liver Disease Supplements; Interna tional Meeting on Inflammatory Bowel Diseases; Capri, Italy; Jun. Feagan Brian G: “Maintenance therapy for inflammatory bowel dis 18-21, 2000, vol. 32, No. Supplement 1, pp. A37 (2000). ease'. American Journal of Gastroenterology, Elsevier Science Inc., Savidge R. S.: “Trimethoprim and Sulphamethoxazole in ulcerative US, vol. 98, No. 12 Supplement, pp. S6-S17 (2003). colitis'. Postgraduate Medical Journal, vol. 45 (1969). Hudson MJ et al.: “The Microbial Flora of the Rectal Mucosa and Supplemental European Search Report completed Sep. 5, 2013, Feces of Patients with Crohns Disease before and during Antimicro which issued in corresponding EP application No. 10841670. bial Chemotherapy”, Journal of Medical Microbiology, vol. 18, No. 3, pp. 335-346 (1984). * cited by examiner US 9,138,441 B2 1. 2 COMPOSITIONS AND METHOD FOR of chronic inflammation remains unclear. As yet, questions TREATMENT AND PROPHYLAXIS OF remain whether commensal enteric bacteria or invasive NFLAMMATORY BOWEL DISEASE strains of pathogenic bacteria, particularly Escherichia coli, are a direct trigger cause in IBD. Both may be contributing FIELD OF INVENTION factors in different subsets of patients. Involvement of intestinal microflora in the pathogenesis of The present invention relates generally to compositions IBD has been suggested but trials on the use of antibiotic and methods for the prophylaxis and treatment of inflamma treatment in patients with UC have produced contrasting tory bowel disease (IBD) due to bacterial infection. More results. See, for example, M. Guslandi, Antibiotics for specifically, this invention envisions the use of probiotic for 10 inflammatory bowel disease: do they work?” Eur: J. Gastro mulations in combination with antibiotics to treat IBD symp enterol. Hepatol., 2005 February; 17(2):145-7: Gionchetti et toms and to reduce the risk of relapse. al., “Review—antibiotic treatment in inflammatory bowel BACKGROUND disease: rifaximin, a new possible approach. Eur: Rev. Med. 15 Pharmacol. Sci., 1999 January-February: 3(1):27-30. How Inflammatory bowel disease (IBD) is a group of inflamma ever, the weight of evidence supports the use of antibiotics tory conditions of the colon and small intestine that affect Such as metronidazole, ciprofloxacin, or rifaximin in the over two million people in the United States and an estimated treatment of IBD. See, Rubin, D.T., et al., “Role of antibiotics eight million people worldwide. The two phenotypes of IBD in the management of inflammatory bowel disease: a review.” most commonly referred to are Crohn's disease (CD) and Rev. Gastroenterol. Disord., 2005; 5 Suppl. 3:S10-5. Studies ulcerative colitis (UC). CD commonly manifests as inflam by J. T. Danzi and others demonstrate the effectiveness of mation of the small intestine, but can affect other parts of the adjuvant use of Sulfamethoxazole-trimethoprin in patients body as well. UC is usually characterized by inflammation of with CD and UC in terms of steroid withdrawal and mainte the mucosa of the colon and rectum. Symptoms of IBD most nance of remission. See Danzi, J. T. “Trimethoprim-Sul commonly include fever, vomiting, diarrhea, bloody stool 25 famethoxazole Therapy of Inflammatory Bowel Disease.” (hematochezia), abdominal pain, and weight loss, but also Gastroenterology, Vol. 96, No. 5, Part 2, p. A110. However, may include a host of other problems. The severity of symp the use of sulfamethoxazole-trimethoprin as a first-line toms may impair the quality of life of patients that suffer from therapy, rather than as an adjuvant to immunosuppressant IBD. therapy, is not suggested. Although the etiology of IBD is poorly understood, many 30 theories have been proposed. UC and CD are commonly One complication associated with the use of broad-spec regarded as autoimmune diseases, with evidence suggesting trum antibiotics is the depletion of beneficial microflora in the they are the result of a misdirected immune response. The gut, leading to opportunistic infection by competing bacteria etiology of IBD appears to involve complex interactions of in the intestine, including Clostridium difficile. C. difficile genetic predisposition, environmental factors, disruption of 35 infection can limit the duration of antibiotic therapy and can the intestinal microbiome, and an overly aggressive immune lead to pseudomembranous colitis, which may compound the response. In addition, evidence linking the ability of intestinal symptoms of IBD. See Trnka, Y. M., et al., “Association of epithelial cells to modify the mucosal immune response, may Clostridium difficile toxin with symptomatic relapse of Suggest an invasive bacterial pathway. The integrity of the gut chronic inflammatory bowel disease. Gastroenterology, epithelial barrier is critical in influencing progression to dis 40 1981 April: 80(4):693-6; Freeman, H. J., “Recent develop ease. Imbalance in intestinal microbiota of gut friendly bac ments on the role of Clostridium difficile in inflammatory teria destroyed by antibiotics as well as opportunistic patho bowel disease.” World J. Gastroenterol., 2008 May 14; gens are implicating factors as well. Additional factors 14(18):2794-6. In fact, it has been suggested that the frequent influencing activation may include the unfolded protein use of broad spectrum antibiotics in treating IBD could exac response (a result of cellular stress), toll like receptors, inva 45 erbate symptoms and prevent remission of UC Symptoms.
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