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Bifidobacterium Bifidum Strains for Application In (19) TZZ _ _T (11) EP 2 481 299 B1 (12) EUROPEAN PATENT SPECIFICATION (45) Date of publication and mention (51) Int Cl.: of the grant of the patent: A23L 33/135 (2016.01) A61K 35/745 (2015.01) 07.12.2016 Bulletin 2016/49 (21) Application number: 11000744.0 (22) Date of filing: 31.01.2011 (54) BIFIDOBACTERIUM BIFIDUM STRAINS FOR APPLICATION IN GASTROINTESTINAL DISEASES BIFIDOBACTERIUM-BIFIDUM-STÄMME ZUR ANWENDUNG BEI MAGEN-DARM-ERKRANKUNGEN SOUCHES DE BIFIDOBACTERIUM BIFIDUM POUR APPLICATION DANS LES MALADIES GASTRO-INTESTINALES (84) Designated Contracting States: • GUGLIELMETTI ET AL.: "Study of the adhesion AL AT BE BG CH CY CZ DE DK EE ES FI FR GB of Bifidobacterium bifidum MIMBb75 to human GR HR HU IE IS IT LI LT LU LV MC MK MT NL NO intestinal cell lines", CURR MICROBIOLOGY, vol. PL PT RO RS SE SI SK SM TR 59, 2009, pages 167-172, XP002634994, • PREISING ET AL: "Selection of Bifidobacteria (43) Date of publication of application: based on adhesion and anti-inflammatory 01.08.2012 Bulletin 2012/31 capacity in vitro for amelioration of Murine colitis", APPLIED AND (73) Proprietor: Dr. Fischer Gesundheitsprodukte ENVIRONMENTALMICROBIOLOGY, vol. 76, no. GmbH 9, May 2010 (2010-05), pages 3048-3051, 82166 Gräfelfing (DE) XP002634995, • LI-QUN ET AL.: "Influence of cell surface (72) Inventors: properties on adhesion ability of bifidobacteria", • Guglielmetti, Simone, Dr. WORLD J. MICROBIOL. BIOTECHNOL., vol. 26, 20122 Milano (IT) 2010, pages 1999-2007, XP002634996, • Mora, Diego, Dr. • DUFFY L C ET AL: "Effectiveness of 20122 Milano (IT) Bifidobacterium bifidum in mediating the clinical course of murine rotavirus diarrhea", PEDIATRIC (74) Representative: Wichmann, Hendrik RESEARCH, WILLIAMS AND WILKINS, Wuesthoff & Wuesthoff BALTIMORE, MD, US, [Online] vol. 35, no. 6, 1 Patentanwälte PartG mbB June 1994 (1994-06-01), pages 690-695, Schweigerstraße 2 XP008136071, ISSN: 0031-3998 Retrieved from 81541 München (DE) the Internet: URL:http://journals.lww.com/pedresearch/Fu (56) References cited: lltext/1994/06000/Effectiveness EP-A1- 1 930 407 EP-A1- 2 270 133 _of_Bifidobacterium_bifidum_in.14.aspx> WO-A1-2009/151329 • GUGLIELMETTI AT AL.: "Implication of an outer surface lipoprotein in adhesion of Bifidobacterium bifidum to Caco-usa2 cells", APPLIED AND ENVRONMENTAL MICROBIOLOGY, vol. 74, no. 15, 2008, pages 4695-4702, XP002634993, Note: Within nine months of the publication of the mention of the grant of the European patent in the European Patent Bulletin, any person may give notice to the European Patent Office of opposition to that patent, in accordance with the Implementing Regulations. Notice of opposition shall not be deemed to have been filed until the opposition fee has been paid. (Art. 99(1) European Patent Convention). EP 2 481 299 B1 Printed by Jouve, 75001 PARIS (FR) (Cont. next page) EP 2 481 299 B1 • GLEINSER M ET AL: "Adhesion of an • DATABASE WPI Week 200103 Thomson anti-inflammatory B. bifidum strain to intestinal Scientific, London, GB; AN 2001-022439 epithelial cells is mediated by proteinaceous cell XP002635000, & RU 2 152 993 C1 wall components", INTERNATIONAL JOURNAL (MED-BIOLOGICAL PROBLEMS INST RES OF MEDICAL MICROBIOLOGY; 61ST CENTRE) 20 July 2000 (2000-07-20) CONFERENCE OF THE • DINAN ET AL.: GASTROENTEROLOGY, vol. 130, DEUTSCHEN-GESELLSCHAFT-FUR-HYGIENE- 1 January 2006 (2006-01-01), pages 304-311, UND-MIK ROBIOLOGIE, URBAN UND FISCHER, • MOUSSAVI ET AL.: CURRENT MICROBILOGY, DE; GÖTTINGEN, GERMANY, vol. 299, no. Suppl. vol. 60, 1 January 2010 (2010-01-01), pages 1, 1 September 2009 (2009-09-01), page 90, 327-335, XP008136069, ISSN: 1438-4221, DOI: • NIV ET AL.: CLINICAL NUTRITION, vol. 24, 1 DOI:10.1016/J.IJMM.2009.08.001 [retrieved on January 2005 (2005-01-01), pages 925-931, 2009-08-18] • DINAN ET AL.: AMERICAN JOURNAL OF • RIEDELET AL.: "Interaction of bifidobacteria with GASTROENTEROLOGY, 1 January 2008 Caco-2 cells adhesion and impact on expression (2008-01-01), pages 2570-2576, profiles", INTERNATIONAL JOURNAL OF FOOD • HARADA ET AL.: JOURNAL OF LEUKOCYTE MICROBIOLOGY, vol. 110, 2006, pages 62-68, BIOLOGY, vol. 56, 1 November 1994 (1994-11-01), XP002634997, pages 559-564, • ALP ET AL.: "The role of hemagglutination and • MAZZUCCHELLI: AMERICAN JOURNAL OF effect of exopolysaccharide production on PATHOLOGY, vol. 144, no. 5, 5 May 1994 bifidobacteria adhesion to Caco-2 cells in vitro", (1994-05-05), pages 997-1007, MICROBIOLOGY AND IMMUNOLOGY, vol. 54, 2010, pages 658-665, XP002634998, • DATABASE WPI Week 200258 Thomson Scientific, London, GB; AN 2002-545753 XP002634999, & RU 2 184 146 C1 (PARTNER STOCK CO) 27 June 2002 (2002-06-27) 2 EP 2 481 299 B1 Description [0001] To date, diseases which are correlated with a functional disorder of the gastrointestinal tract and/or which are correlated with undesirable gastrointestinal inflammatory activity are common diseases with widespread prevalence. 5 Diseases of both groups are characterized by abdominal pain, discomfort, distension, bloating, diarrhoea, constipation, digestive disorder, urgency and/or reduced and/or increased number of bowel movements, feeling of incomplete evac- uation and/or combinations thereof, thereby leading to a significantly reduced overall wellbeing of the persons affected. In particular, with respect to irritable bowel syndrome (IBS) an efficient treatment is still lacking (Brenner and Chey, 2009). Several medications for IBS have been withdrawn or restricted due to adverse health effects. Additionally, current 10 therapies are mainly targeted at single symptoms and do not alleviate IBS and improve quality of life (QoL) in general. [0002] It is widely believed that diseases which are correlated with a functional disorder of the gastrointestinal tract, such as IBS or inflammatory bowel diseases, are accompanied (i) with an imbalance of the intestinal microbiota (Kassinen et al., 2007) and/or (ii) a dysfunctional intestinal barrier of the gastrointestinal tract (Marshall et al., 2004). This is thought to result in a reduction of probiotic bacteria, such as Bifidobacteria, in the gastrointestinal tract. Additionally, it is believed 15 that a dysfunctional intestinal barrier causes undesirable entrance of facultative pathogenic bacteria into the mucosa which can lead to gastrointestinal inflammatory activity, subsequently. Recent studies propose that this inflammation triggers typical IBS symptoms such as pain, motility and dysfunction of the intestine. [0003] An imbalance of the intestinal microbiota is mainly characterised by a reduced number of non-pathogenic microorganisms of human origin, such as Bifidobacteria, whereas the number of facultative pathogenic microorganisms, 20 such as Enterobacteria, is increased (Jian-Min et al., 2004). This imbalance is believed to lead to an increased production of gaseous compounds and short-chain fatty acids, dysmotility, flatulence and pain of the persons affected. Thus, for bringing the intestinal microbiota back into balance or improving intestinal barrier, probiotic bacteria came into focus. "Probiotics" comprising probiotic bacteria of non-pathogenic human origin have been defined as living microbial food and drugs which upon ingestion in certain numbers exert health effects beyond inherent basic nutrition. Mixtures of 25 various microorganisms, particularly species of Lactobacillus and Streptococcus, have traditionally been used in fer- mented dairy products or drugs to promote health. [0004] Many studies have been performed on this issue, however, as an imbalance of the intestinal microbiota is only one side of the coin, it is not surprising that most therapies which simply focus on the delivery of probiotics to the gastrointestinal tract, have not been successful in alleviating all symptoms of patients suffering from a functional disorder 30 of the gastrointestinal tract. For example, IBS is diagnosed by the Rome III criteria, which are basically: abdominal pain or discomfort on at least 3 days per month during the last three months with symptoms which started at least 6 months ago combined with at least two criteria of (a) ease through defecation, (b) starting associated with a change in stool frequency or (c) in stool consistency and is often accompanied by bloating or distention, and bowel movement difficulties, either constipation and/or diarrhoea. -Coming along with these symptoms, patients may suffer from impaired social and 35 personal function and diminished quality of life. Nevertheless, even if the symptoms, such as pain/discomfort, disten- sion/bloating, urgency are largely removed an improvement of the overall health related quality of life (QoL) of the patient is very desirable. To date, none of the treatments provided, including probiotics and others, have been able to improve the symptoms pain/discomfort, distension/bloating and digestive disorder simultaneously with the QoL. [0005] In this respect, the second important aspect in the development of a functional disorder of the gastrointestinal 40 tract has to be considered which concerns a dysfunctional intestinal barrier of the gastrointestinal tract characterised by an increased permeability thereof. One very popular theory in this respect is that perturbations in the gut allow pathogenic microorganisms - which might dominate in case of an imbalance of the intestinal microbiota - to pass the barrier and penetrate the mucosa, thereby causing inflammatory reactions. Based on this hypothesis, several studies have been performed which focus on the treatment and alleviation of the inflammatory reaction and its effects
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