Patent AU-2016358297-B2 (AU)
Title: Process for the therapeutic management of diarrhea predominant irritable bowel syndrome using Bacillus Coagulans SBC37-01, MTCC 5856
Inventor: MAJEED MUHAMMED
IPC: A61K35/742
Filed: 2016-01-07
Granted: 2023-05-25
Abstract: 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 2017/119883 Al 
13 July 2017 (13.07.2017) WIPOIPCT 
(51) International Patent Classification: Bangalore, KN 560 058 (IN). SANKARAN, Natarajan; 
A61K35/66(2015.01) A61P1/00(2006.01) Sami Labs Limited, 19/1 and 19/2, I Main, II Phase, 
A 61K 35/74 (2015.01) A61P 1/12 (2006.01) Peenya Industrial Area, Bangalore, KN 560 058 (IN).  
(21) International Application Number: (81) Designated States (unless otherwise indicated, for every 
PCT/US2016/012409 kind of national protection available): AE, AG, AL, AM, 
(22) InternationalFilingDate: AOAT, AU, AZ, BA, BB, BG, BH, BN, BR, BW, BY, (2 Intenatona Filing Date:6 BZ, CA, CH, CL, CN, CO, CR, CU, CZ, DE, DK, DM, 
7January2016(07.01.2016) DO, DZ, EC, EE, EG, ES, Fl, GB, GD, GE, GH, GM, GT, 
(25) Filing Language: English HN, HR, HU, ID, IL, IN, IR, IS, JP, KE, KG, KN, KP, KR, 
KZ, LA, LC, LK, LR, LS, LU, LY, MA, MD, ME, MG, 
(26) Publication Language: English MK, MN, MW, MX, MY, MZ, NA, NG, NI, NO, NZ, OM, 
(71) Applicant: SAMI LABS LIMITED [IN/IN]; 19/1 & 19/2 PA, PE, PG, PH, PL, PT, QA, RO, RS, RU, RW, SA, SC, 
I Main II Phase, Peenya Industrial Estate/Area, Bangalore SD, SE, SG, SK, SL, SM, ST, SV, SY, TH, TJ, TM, TN, 
560 058 (IN). TR, TT, TZ, UA, UG, US, UZ, VC, VN, ZA, ZM, ZW.  
(72) Inventors: MAJEED, Muhammed; Founder and Man- (84) Designated States (unless otherwise indicated, for every 
aging Director, Sabinsa Corporation, 20 Lake Drive, East kind of regional protection available): ARIPO (BW, GH, 
Windsor, NJ 08520 (US). NAGABHUSHANAM, GM, KE, LR, LS, MW, MZ, NA, RW, SD, SL, ST, SZ, 
Kalyanam; Sabinsa Corporation, President-R&D, 20 Lake TZ, UG, ZM, ZW), Eurasian (AM, AZ, BY, KG, KZ, RU, 
Drive, East Windsor, NJ 08520 (US). VAIDYANATHAN, TJ, TM), European (AL, AT, BE, BG, CH, CY, CZ, DE, 
Priti; Sami Labs Limited, 19/1 and 19/2, I Main, II Phase, DK, EE, ES, Fl, FR, GB, GR, HR, HU, IE, IS, IT, LT, LU, 
Peenya Industrial Area, Bangalore, KN 560 058 (IN). AR- LV, MC, MK, MT, NL, NO, PL, PT, RO, RS, SE, SI, SK, 
UMUGAM, Sivakumar; Sami Labs Limited, 19/1 and SM, TR), OAPI (BF, BJ, CF, CG, CI, CM, GA, GN, GQ, 
19/2, I Main, II Phase, Peenya Industrial Area, Bangalore, GW,KM,ML,MR,NE,SN,TD,TG).  
KN 560 058 (IN). KARRI, Suresh; Sami Labs Limited, Declarations under Rule 4.17: 
19/1 and 19/2, I Main, II Phase, Peenya Industrial Area, ofinventorship(Rule4.17(ivp 
[Continued on nextpage] 
(54) Title: PROCESS FOR E THERAPEUTIC MANAGEMENT OF DIARRHEA PREDOMINANT IRRITABLE BOWEL 
SYNDROME USING BACILLUS COAGULANS SBC37-01, MTCC 5856 
Fig.1 (57) Abstract: The present invention discloses a process for the therapeutic 
management of diarrhea predominant irritable bowel syndrome in humans 
Screened=36 comprising the oral administration of Bacillus coagulans SBC37-01, MTCC 
inclusion and 5856 (containing not less than 2 billion spores) along with standard treatment 
E-I-s-own of care in a specific manner.  
critena 
---+ ScreenFaihtres--Nil 
Enrolled-36 
-acilh og uan PLACERT grouphn=8) 
SBC37-01,MTCC5856group 
- ~ (n=18) 
Study Proccdurcs 
Ealuatious and Assessmentson Day 0, 30, 60 uand 90 
PatiebsomnpletdstA Parienmscompletedsriad 
hacilluC gulami I HOgroup 1n=14); 
SBC37-01, MTCC 5856 group Dop ouus-4 
(n-17); Drop outs-l 
Total numberofpaientswhocompletedthestudy:
W O 2017/119883 A 1 ||1II||II|ItVIlIllV|||||||I||I||||||II |||I||||I ||||I||||||||I| 
Published: 
- with international search report (Art. 21(3))