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W O 2017/079450 Al 11 May 2017 (11.05.2017) W IPOI PCT (12) INTERNATIONAL APPLICATION PUBLISHED UNDER THE PATENT COOPERATION TREATY (PCT) (19) World Intellectual Property Organization International Bureau (10) International Publication Number (43) International Publication Date W O 2017/079450 Al 11 May 2017 (11.05.2017) W IPOI PCT (51) International Patent Classification: AO, AT, AU, AZ, BA, BB, BG, BH, BN, BR, BW, BY, A61K35/741 (2015.01) A61K 35/744 (2015.01) BZ, CA, CH, CL, CN, CO, CR, CU, CZ, DE, DJ, DK, DM, A61K 35/745 (2015.01) A61K35/74 (2015.01) DO, DZ, EC, EE, EG, ES, Fl, GB, GD, GE, GH, GM, GT, C12N1/20 (2006.01) A61K 9/48 (2006.01) HN, HR, HU, ID, IL, IN, IR, IS, JP, KE, KG, KN, KP, KR, A61K 45/06 (2006.01) KW, KZ, LA, LC, LK, LR, LS, LU, LY, MA, MD, ME, MG, MK, MN, MW, MX, MY, MZ, NA, NG, NI, NO, NZ, (21) International Application Number: OM, PA, PE, PG, PH, PL, PT, QA, RO, RS, RU, RW, SA, PCT/US2016/060353 SC, SD, SE, SG, SK, SL, SM, ST, SV, SY, TH, TJ, TM, (22) International Filing Date: TN, TR, TT, TZ, UA, UG, US, UZ, VC, VN, ZA, ZM, 3 November 2016 (03.11.2016) ZW. (25) Filing Language: English (84) Designated States (unless otherwise indicated,for every kind of regional protection available): ARIPO (BW, GH, (26) Publication Language: English GM, KE, LR, LS, MW, MZ, NA, RW, SD, SL, ST, SZ, (30) Priority Data: TZ, UG, ZM, ZW), Eurasian (AM, AZ, BY, KG, KZ, RU, 62/250,277 3 November 2015 (03.11.2015) US TJ, TM), European (AL, AT, BE, BG, CH, CY, CZ, DE, DK, EE, ES, Fl, FR, GB, GR, HR, HU, IE, IS, IT, LT, LU, (71) Applicants: THE BRIGHAM AND WOMEN'S HOS- LV, MC, MK, MT, NL, NO, PL, PT, RO, RS, SE, SI, SK, PITAL [US/US]; 75 Francis Street, Boston, Massachusetts SM, TR), OAPI (BF, BJ, CF, CG, CI, CM, GA, GN, GQ, 02115 (US). CHILDREN'S MEDICAL CENTER COR- GW, KM, ML, MR, NE, SN, TD, TG). PORATION [US/US]; 55 Shattuck Street, Boston, Mas- Declarations under Rule 4.17: sachusetts 02115 (US). to applyfor and be granted a (72) Inventors: CHATILA, Talal, A.; 3 Indian Hill Road, Bel- as to applicant'sentitlement mont, Massachusetts 02478 (US). BRY, Lynn; 76 Elm patent (Rule 4.17(iip Street, #209, Jamaica Plain, Massachusetts 02130 (US). - as to the applicant'sentitlement to claim the priority of the GERBER, Georg; EBRC-422a, 221 Longwood Avenue, earlier application (Rule 4.17(iii)) Boston, Massachusetts 02115 (US). ABDEL-GADIR, Published: Azza; 351 Columbus Avenue, Boston, Massachusetts 02116 (US). RACHID, Rima; 76 Chester Road, Unit 1, - with internationalsearch report (Art. 21(3)) Belmont, Massachusetts 02478 (US). - before the expiration of the time limit for amending the (74) Agents:A : RESNICK,Cclaims David S. et al.; Nixon Peabody LLP, aedet and toRl be republished82h in the event of receipt of 100 Summer St., Boston, Massachusetts 02110-2131 (US). amendments (Rule 48.2(h)) (81) Designated States (unless otherwise indicated,for every kind of nationalprotection available): AE, AG, AL, AM, C(54) Title: THERAPEUTIC MICROBIOTA FOR THE TREATMENT AND/OR PREVENTION OF FOOD ALLERGY (57) Abstract: Disclosed are methods and compositions for the prevention and treatment of food allergy. i particular, described herein are microbial consortia, including minimal microbial consortia, that can prevent and/or cure food allergy. In certain embodi ments, the consortia comprise certain members of the taxa Clostridiales and/or Bacteroidetes. WO 2017/079450 PCT/US2016/060353 THERAPEUTIC MICROBIOTA FOR THE TREATMENT AND/OR PREVENTION OF FOOD ALLERGY GOVERNMENT SUPPORT [0001] This invention was made with Government Support under Grant Nos. 1R56A11 1798-01 and P30 DK056338 awarded by the National Institutes of Health. The Government has certain rights in the invention. FIELD OF THE DISCLOSURE [0002] The present disclosure relates to the treatment and/or prevention of food allergy. BACKGROUND [0003] Food allergies are a growing public health problem in both developed and rapidly developing countries and affects large numbers of children and adults. The incidence of food allergy has increased dramatically in the last few decades. This increase can be associated with sensitization to multiple foods in up to 50% of subjects. Growing evidence indicates that the microbial flora is a key environmental influence in programming oral tolerance. SUMMARY [0004] Provided herein are methods and compositions for the treatment and/or prevention of food allergy, based in part, on the discovery that altered intestinal microbiota (e.g., from antibiotic treatments, C-section births, diet etc.) can promote food allergy while some combinations of microbes can prevent and/or cure food allergies. [0005] Accordingly, provided herein in one aspect is a pharmaceutical composition comprising: (i) a preparation comprising a minimal microbial consortium consisting essentially of four to eleven strains of viable gut bacteria, in an amount sufficient to treat or prevent a food allergy when administered to an individual in need thereof, and (ii) a pharmaceutically acceptable carrier. [0006] Another aspect provided herein relates to a pharmaceutical composition comprising a minimal microbial consortium of culturable species, and a pharmaceutically acceptable carrier, wherein the consortium is comprised in at least four of the preparations selected from the group consisting of: (i) a preparation of a viable, culturable, anaerobic gut bacterial strain(s) that expresses exopolysaccharide, lipoteichoic acid (LTA), lipopolysaccharide (LPS) or other microbial adjuvant molecules that promote the development of regulatory T cells (Treg); (ii) a preparation of a viable, culturable, anaerobic gut bacterial strain(s) that produces butyrate and/or propionate fermentation products via fermentation of carbohydrates and other carbon sources in the gut lumen; (iii) a preparation of one or more viable, culturable, anaerobic gut bacterial strains that alone or in 1 WO 2017/079450 PCT/US2016/060353 combination performs the full complement of bile acid transformations; (iv) a preparation of a viable, culturable, anaerobic gut bacterial strain that produces compounds capable of stimulating the aryl hydrocarbon receptor (AhR) receptor pathway in gut epithelial cells, antigen presenting cells and/or T cells to stimulate development of regulatory T cell responses; (v) a preparation of a viable, culturable, anaerobic gut bacterial strain(s) that produces compounds capable of stimulating the pregnane X receptor with beneficial effects upon gut barrier function and/or development of regulatory T cell responses; (vi) a preparation of a viable, culturable, anaerobic gut bacterial strain(s) that produces compounds capable of stimulating the RORgamma (RAR-related orphan receptor gamma) pathways to stimulate development of regulatory T cell responses via direct stimulation or RORgamma-activated pathways in gut antigen presenting cells and/or epithelial cells that then stimulate regulatory T cell responses; (vii) a preparation of viable, culturable, anaerobic gut bacterial strain(s) that stimulates host production of mucins and complex glycoconjugates that improve gut barrier function and colonization by protective commensal species; (viii) a preparation of a viable, culturable, anaerobic gut bacterial strain(s) that alters the gut luminal environment to reduce the deleterious activities of dysbiotic species promoting development of unhealthy allergic T cell responses to food antigens; (ix) a preparation of a viable, culturable, anaerobic gut bacterial strain(s) that alters the gut luminal environment to promote improved colonization by other members of the administered consortium for any of the above stated effects, and/or colonization by existing beneficial species in the patients underlying microbiota; (x) a preparation of a viable, culturable, anaerobic gut bacterial strain(s) that promotes the colonization or growth of a bacterial strain in a preparation of (i) (ix) above, in vivo. [0007] In one embodiment of this aspect and all other aspects described herein, the viable, culturable, anaerobic gut bacterial strain(s) that expresses exopolysaccharide that promotes the development of regulatory T cells (Treg) is selected from the group consisting of: Eubacterium rectale, Clostridium ramosum, Butyrovibrio crossatus, Roseburia intestinalis, Clostridium scindens, Clostridium hylemonae, Hungatella hathawayi, Clostridium symbiosum, Faecalibacterium prausnitzii, Subdoligranulum variabile, Bacteroides thetaiotaomicron, Bacteroides fragilis, Bacteroides ovatus, Parabacetroidesgoldsteinii, Parabacteroidesmerdae, Parabacteroidesdistasonis, and Prevotella tannerae. [0008] In another embodiment of this aspect and all other aspects provided herein, the viable, culturable, anaerobic gut bacterial strain(s) that produces butyrate, propionate and/or succinate fermentation products via fermentation of carbohydrates in the gut lumen is selected from the group consisting of: Bacteroides fragilis, Bacteroides thetaiotaomicron, Bacteroides ovatus, Clostridium sardiniensis, Clostridium hiranonsis, Facealibacteriumprausnitzii, Butyrovibrio spp., Eubacterium rectale and Roseburia intestinalis [0009] In another embodiment of this aspect and all other aspects provided herein, the one or more viable, culturable, anaerobic gut bacterial strains that alone or in combination performs the full 2 WO 2017/079450 PCT/US2016/060353 complement of bile acid transformations is Clostridium scindens, Clostridium hiranonsis,Clostridium sardiniensisand/or Bacteroides spp. [0010] In another embodiment of this aspect and all other aspects provided herein, the viable, culturable, anaerobic gut
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