Granted Patent
B2
US 12,285,447 · App. 17/505,029 · Granted Apr 29, 2025
Methods and compositions for treating ulcerative colitis
Assignee:
FINCH THERAPEUTICS HOLDINGS LLC
View Patent ↗
Loading inventors, assignments & file history…
Abstract
The present disclosure provides methods and pharmaceutical compositions for treating ulcerative colitis (UC) in a subject in need thereof. In particular, the compositions described here comprise or are designed based on fecal bacteria associated with FMT-based UC treatment success or failure. Also provided are methods for screening patients for their suitability for a fecal bacteria-based UC treatment. Further provided are methods for screening fecal donors for optimized source materials for producing a fecal bacteria-based pharmaceutical composition.
Claims (28)
1. A method comprising:
a. selecting a bacterial isolate based on an abundance of a metabolite produced by the bacterial isolate, wherein the abundance of the metabolite is above a pre-determined limit corresponding to a level of the metabolite in a healthy subject, wherein the metabolite is selected from the group consisting of a secondary bile acid, a short chain fatty acid (SCFA), and a combination thereof;
b. isolating the bacterial isolate from a stool of a human donor; and
c. formulating the bacterial isolate into a pharmaceutical composition.
2. The method of claim 1 , wherein the method further comprises administering the pharmaceutical composition to a subject having ulcerative colitis (UC).
3. The method of claim 1 , wherein the human donor comprises multiple human donors.
4. The method of claim 1 , wherein the pharmaceutical composition further comprises a non-selective fecal microbiota from a donor.
5. The method of claim 1 , wherein the bacterial isolate comprises cultured bacteria comprising a bacterial species.
6. The method of claim 5 , wherein the bacterial species is of a genus selected from the group consisting of Eubacterium, Bacteroides, Faecalibacterium and Roseburia.
7. The method of claim 6 , wherein the genus is Eubacterium and the bacterial species is Eubacterium rectale.
8. The method of claim 6 , wherein the genus is Faecalibacterium and the bacterial species is Faecalibacterium prausnitzii.
9. The method of claim 8 , wherein the bacterial isolate is derived from a healthy human donor.
10. The method of claim 9 , wherein administration of the bacterial isolate derived from the donor to a subject having UC is associated with treatment of the UC.
11. The method of claim 5 , wherein the method further comprises incorporating viable bacteria of the bacterial species into the pharmaceutical composition.
12. The method of claim 11 , wherein the viable bacteria comprise lyophilized bacteria.
13. The method of claim 11 , wherein the pharmaceutical composition is encapsulated.
14. The method of claim 1 , wherein the metabolite is SCFA.
15. The method of claim 14 , wherein the SCFA is butyrate.
16. The method of claim 1 , wherein the metabolite is secondary bile acid.
17. The method of claim 16 , wherein the secondary bile acid is selected from the group consisting of lithocholic acid, deoxycholic acid, ursodeoxycholic acid, and a combination thereof.
18. A method of selecting a bacterial isolate for manufacturing a pharmaceutical composition for treating ulcerative colitis (UC) in a subject in need thereof, wherein the method comprises
a. determining in a bacterial isolate the abundance of a metabolite produced by the bacterial isolate, wherein the metabolite is selected from the group consisting of a secondary bile acid, a short chain fatty acid (SCFA), and a combination thereof;
b. selecting the bacterial isolate based on the abundance of the metabolite, wherein the abundance of the metabolite is above a pre-determined limit corresponding to a level of the metabolite in a healthy subject;
c. isolating the bacterial isolate from a stool of a human donor; and
d. producing a pharmaceutical composition using the selected bacterial isolate, wherein the pharmaceutical composition is effective at treating UC.
19. A method for selecting a subject for treatment of ulcerative colitis (UC), the method comprising
determining in the subject abundance of a metabolite, wherein the metabolite is selected from the group consisting of a secondary bile acid, a short chain fatty acid (SCFA), and a combination thereof;
selecting the subject for treatment based upon abundance of the metabolite below a pre-determined limit corresponding to a level of the metabolite in a healthy subject.
Assignments (2)
ASSIGNMENT OF ASSIGNOR'S INTEREST
Recorded May 13, 2022
From: BORODY, THOMAS JULIUS
To: CRESTOVO HOLDINGS LLC
Reel/Frame 060066/0274 →
CHANGE OF NAME
Recorded May 13, 2022
From: CRESTOVO HOLDINGS LLC
To: FINCH THERAPEUTICS HOLDINGS LLC
Reel/Frame 060066/0341 →
Continuity (4)
Provisional Application
62697796
· Jul 13, 2018
Provisional Application
62697810
· Jul 13, 2018
References Cited (400)
US 3192116A
· Mose et al.
· 1965
[cited by applicant]
US 3320130A
· Henry
· 1967
[cited by applicant]
US 3713836A
· Carlsson
· 1973
[cited by applicant]
US 4098728A
· Rosenblatt
· 1978
[cited by applicant]
US 4309782A
· Paulin
· 1982
[cited by applicant]
US 4332790A
· Sozzi et al.
· 1982
[cited by applicant]
US 4335107A
· Snoeyenbos et al.
· 1982
[cited by applicant]
US 4394377A
· Spires
· 1983
[cited by applicant]
US 4452779A
· Cockerill
· 1984
[cited by applicant]
US 4536409A
· Farrell et al.
· 1985
[cited by applicant]
US 4657762A
· Mikkola et al.
· 1987
[cited by applicant]
US 4710379A
· Kawai et al.
· 1987
[cited by applicant]
US 4892731A
· Arai et al.
· 1990
[cited by applicant]
US 4975286A
· Hechter
· 1990
[cited by applicant]
US 5213807A
· Chemburkar et al.
· 1993
[cited by applicant]
US 5266315A
· Taguchi et al.
· 1993
[cited by applicant]
US 5443826A
· Borody
· 1995
[cited by applicant]
US 5728380A
· Allen et al.
· 1998
[cited by applicant]
US 5800821A
· Acheson et al.
· 1998
[cited by applicant]
US 5837238A
· Casas et al.
· 1998
[cited by applicant]
US 5858356A
· Wolf et al.
· 1999
[cited by applicant]
US 5902578A
· Halpin-Dohnalek et al.
· 1999
[cited by applicant]
US 5902743A
· Luchansky et al.
· 1999
[cited by applicant]
US 6087386A
· Chen et al.
· 2000
[cited by applicant]
US 6162464A
· Jacob et al.
· 2000
[cited by applicant]
US 6245740B1
· Goldenberg et al.
· 2001
[cited by applicant]
US 6284274B1
· Merrill et al.
· 2001
[cited by applicant]
US 6428783B1
· Khachatrian et al.
· 2002
[cited by applicant]
US 6479051B1
· Bruce
· 2002
[cited by applicant]
US 6514531B1
· Alaux et al.
· 2003
[cited by applicant]
US 6645530B1
· Borody
· 2003
[cited by applicant]
US 6649397B1
· Nakamura
· 2003
[cited by applicant]
US 6756032B1
· Tepper et al.
· 2004
[cited by applicant]
US 6926907B2
· Plachetka
· 2005
[cited by applicant]
US 6979674B1
· Goldenberg et al.
· 2005
[cited by applicant]
US 6984513B2
· Brown et al.
· 2006
[cited by applicant]
US 7018629B2
· Jacob et al.
· 2006
[cited by applicant]
US 7374753B1
· Farmer et al.
· 2008
[cited by applicant]
US 7541091B2
· Sisson et al.
· 2009
[cited by applicant]
US 7749509B2
· Cobb et al.
· 2010
[cited by applicant]
US 7763276B1
· Shodai et al.
· 2010
[cited by applicant]
US 7799341B2
· Porzio et al.
· 2010
[cited by applicant]
US 7815956B2
· Lee et al.
· 2010
[cited by applicant]
US 7846475B2
· Shiraishi et al.
· 2010
[cited by applicant]
US 7888062B1
· Garner et al.
· 2011
[cited by applicant]
US 7998510B2
· Caswell
· 2011
[cited by applicant]
US 8168171B2
· Mogna et al.
· 2012
[cited by applicant]
US 8460648B2
· Borody
· 2013
[cited by applicant]
US 8586029B2
· Kasper et al.
· 2013
[cited by applicant]
US 8637297B2
· Fernandez et al.
· 2014
[cited by applicant]
US 8658153B2
· Daube et al.
· 2014
[cited by applicant]
US 8771673B2
· Cobb et al.
· 2014
[cited by applicant]
US 9040036B2
· Borody
· 2015
[cited by applicant]
US 9050358B2
· Borody
· 2015
[cited by applicant]
US 9308226B2
· Borody
· 2016
[cited by applicant]
US 9320763B2
· Borody
· 2016
[cited by applicant]
US 9408872B2
· Borody
· 2016
[cited by applicant]
US 9468658B2
· Borody
· 2016
[cited by applicant]
US 9572841B2
· Borody
· 2017
[cited by applicant]
US 9572842B2
· Borody
· 2017
[cited by applicant]
US 9610308B2
· Borody
· 2017
[cited by applicant]
US 9623056B2
· Borody
· 2017
[cited by applicant]
US 9719144B2
· Krajmalnik-Brown et al.
· 2017
[cited by applicant]
US 20010014322A1
· Chen et al.
· 2001
[cited by applicant]
US 20020013270A1
· Bolte
· 2002
[cited by applicant]
US 20020022019A1
· Laulund
· 2002
[cited by applicant]
US 20030092163A1
· Collins et al.
· 2003
[cited by applicant]
US 20030092724A1
· Kao et al.
· 2003
[cited by applicant]
US 20040062757A1
· Finegold
· 2004
[cited by applicant]
US 20040170617A1
· Finegold
· 2004
[cited by applicant]
US 20060076536A1
· Barshied
· 2006
[cited by applicant]
US 20060115465A1
· Macfarlane et al.
· 2006
[cited by applicant]
US 20060177424A1
· Cobb et al.
· 2006
[cited by applicant]
US 20060275223A1
· Burr
· 2006
[cited by applicant]
US 20070059296A1
· Chen
· 2007
[cited by applicant]
US 20100112003A1
· Collins et al.
· 2010
[cited by applicant]
US 20100178413A1
· Gorris
· 2010
[cited by applicant]
US 20100184785A1
· Kolter et al.
· 2010
[cited by applicant]
US 20100222311A1
· Thommes et al.
· 2010
[cited by applicant]
US 20100233278A1
· Ookawa et al.
· 2010
[cited by applicant]
US 20100247489A1
· Saur-Brosch et al.
· 2010
[cited by applicant]
US 20100247665A1
· Takahashi
· 2010
[cited by applicant]
US 20100255231A1
· Chau et al.
· 2010
[cited by applicant]
US 20100255307A1
· Gonze et al.
· 2010
[cited by applicant]
US 20100285164A1
· Schaible et al.
· 2010
[cited by applicant]
US 20110008554A1
· Chen et al.
· 2011
[cited by applicant]
US 20110045222A1
· Peters
· 2011
[cited by applicant]
US 20110081320A1
· Westall et al.
· 2011
[cited by applicant]
US 20110218216A1
· Vivek et al.
· 2011
[cited by applicant]
US 20120020941A1
· Wacklin et al.
· 2012
[cited by applicant]
US 20120064133A1
· Chauhan et al.
· 2012
[cited by applicant]
US 20130259899A1
· Allen-Vercoe et al.
· 2013
[cited by applicant]
US 20140255351A1
· Berstad et al.
· 2014
[cited by applicant]
US 20140342438A1
· Allen-Vercoe et al.
· 2014
[cited by applicant]
US 20140363397A1
· Allen-Vercoe et al.
· 2014
[cited by applicant]
US 20150093360A1
· McKenzie et al.
· 2015
[cited by applicant]
US 20150224152A1
· Littman et al.
· 2015
[cited by applicant]
US 20150238545A1
· Borody
· 2015
[cited by applicant]
US 20150297642A1
· Borody
· 2015
[cited by applicant]
US 20150374761A1
· Sadowsky et al.
· 2015
[cited by applicant]
US 20160089363A1
· Borody
· 2016
[cited by applicant]
US 20160339065A1
· Adams et al.
· 2016
[cited by applicant]
US 20170348360A1
· Borody
· 2017
[cited by applicant]
US 20190015461A1
· Borody
· 2019
[cited by applicant]
AU 2001276160B2
· 2007
[cited by applicant]
CA 1333564
· 1994
[cited by applicant]
CA 2391422A1
· 2004
[cited by applicant]
CN 1561387A
· 2005
[cited by applicant]
CN 101496819A
· 2009
[cited by applicant]
CN 201441672U
· 2010
[cited by applicant]
DE 2134179A1
· 1973
[cited by applicant]
EP 303426A2
· 1989
[cited by applicant]
EP 456418A2
· 1991
[cited by applicant]
EP 433299B1
· 1998
[cited by applicant]
EP 1514572A2
· 2005
[cited by applicant]
EP 1514572A3
· 2006
[cited by applicant]
EP 1800688A1
· 2007
[cited by applicant]
EP 1514572B1
· 2008
[cited by applicant]
EP 2823822B1
· 2016
[cited by applicant]
FR 1275M
· 1962
[cited by applicant]
FR 2427M
· 1964
[cited by applicant]
FR 2828M
· 1964
[cited by applicant]
FR 5528M
· 1967
[cited by applicant]
FR 2244464A1
· 1975
[cited by applicant]
GB 1271674A
· 1972
[cited by applicant]
JP 6467192
· 1989
[cited by applicant]
JP H05306221A
· 1993
[cited by applicant]
JP H07242539A
· 1995
[cited by applicant]
JP H07242557A
· 1995
[cited by applicant]
JP 3144556B2
· 2001
[cited by applicant]
JP 2004501095
· 2004
[cited by applicant]
JP 2005118544A
· 2005
[cited by applicant]
JP 2008106066
· 2008
[cited by applicant]
JP 2010513359
· 2010
[cited by applicant]
JP 2010520234A
· 2010
[cited by applicant]
KR 100913405B1
· 2009
[cited by applicant]
WO WO9001335A1
· 1990
[cited by applicant]
WO WO9533046A1
· 1995
[cited by applicant]
WO WO9611014A1
· 1996
[cited by applicant]
WO WO9813068A1
· 1998
[cited by applicant]
WO WO0007571A2
· 2000
[cited by applicant]
WO WO00015760
· 2000
[cited by applicant]
WO WO0042168A2
· 2000
[cited by applicant]
WO WO0207741A1
· 2002
[cited by applicant]
WO WO03033681A2
· 2003
[cited by applicant]
WO WO2005017095A2
· 2005
[cited by applicant]
WO WO2006127355A2
· 2006
[cited by applicant]
WO WO2008077614A2
· 2008
[cited by applicant]
WO WO2008105715A2
· 2008
[cited by applicant]
WO WO2008117266A2
· 2008
[cited by applicant]
WO WO2008117267A2
· 2008
[cited by applicant]
WO WO2008077614A3
· 2009
[cited by applicant]
WO WO2009024429A2
· 2009
[cited by applicant]
WO WO2009026306A2
· 2009
[cited by applicant]
WO WO2009055362A1
· 2009
[cited by applicant]
WO WO2010040020A1
· 2010
[cited by applicant]
WO WO2011033310A1
· 2011
[cited by applicant]
WO WO2011094027A1
· 2011
[cited by applicant]
WO WO2011110347A2
· 2011
[cited by applicant]
WO WO2011151941A1
· 2011
[cited by applicant]
WO WO2012013861A2
· 2012
[cited by applicant]
WO WO2012016287A2
· 2012
[cited by applicant]
WO WO2012045150A1
· 2012
[cited by applicant]
WO WO2012122478A1
· 2012
[cited by applicant]
WO WO2012016287A3
· 2012
[cited by applicant]
WO WO2013037067A1
· 2013
[cited by applicant]
WO WO2013090825A1
· 2013
[cited by applicant]
WO WO2014070014A1
· 2014
[cited by applicant]
WO WO2014078911A1
· 2014
[cited by applicant]
WO WO2014152338A1
· 2014
[cited by applicant]
WO WO2014152484A1
· 2014
[cited by applicant]
WO WO2015006355A2
· 2015
[cited by applicant]
WO WO2015051323A1
· 2015
[cited by applicant]
WO WO2015077794A1
· 2015
[cited by applicant]
WO WO2015095241A2
· 2015
[cited by applicant]
WO WO2015124637A1
· 2015
[cited by applicant]
WO WO2016133450A1
· 2016
[cited by applicant]
WO WO2016183577A1
· 2016
[cited by applicant]
WO WO2016191356A1
· 2016
[cited by applicant]
WO WO2017075098A1
· 2017
[cited by applicant]
WO WO2017152137A2
· 2017
[cited by applicant]
“Autoimmune Disease List,”
[cited by applicant]
“Certain infectious and parasitic diseases (A00-B99),”
[cited by applicant]
“Spore-Forming Gram-Positive Bacilli:
[cited by applicant]
“ARGF—‘Autologous Rehabilitation of Gastrointestinal Flora,’”Medipex Report for Medilink NW, pp. 1-42, n.d., Web, Feb. 10, 2012 <http://www.bacteriotherapy.org/docs/medipex-report.pelf>.
[cited by applicant]
“Frequently Asked Questions about Clostridium difficile for Healthcare Providers,” Healthcare-associated Infections (HAis), Centers for Disease Control and Prevention, pp. 1-6, Nov. 25, 2010, updated Mar. 6, 2012, Web, …
[cited by applicant]
“Functional Anatomy of Prokaryotic and Eukaryotic Cells,” printed Mar. 16, 2017 <http://classes.midlandstech.edu/carterp/courses/bio225/chap04/lecture2.htm>.
[cited by applicant]
“Monilia,” Def. 1, Stedman's Medical Dictionary, n.d., Web, Nov. 22, 2005.
[cited by applicant]
“Probiotic,” Def. 1, MSN Encarta—Dictionary, Encarta, n.d., Web, Dec. 1, 2005.
[cited by applicant]
Aas et al., “Recurrent Clostridium difficile Colitis: Case Series Involving 18 Patients Treated with Donor Stool Administered Via a Naso gastric Tube,”
[cited by applicant]
Abrams, “Open-Label, Uncontrolled Trial of Bowel Sterilization and Repopulation with Normal Bowel Flora for Treatment of Inflammatory Bowel Disease,”
[cited by applicant]
Acha et al., “Changes of Viability and composition of the
[cited by applicant]
Agrawal et al., “‘Global warming’ to Mycobacterium avium subspecies paratuberculosis,”
[cited by applicant]
Agrawal et al., “A Long-Term Follow-Up Study of the Efficacy and Safety of Fecal Microbiota Transplant (FMT) for Recurrent/Severe/Complicated
[cited by applicant]
Aitken et al., “Demonstration of Intracellular
[cited by applicant]
Akao et al., “A Purgative Action of Barbaloin Is Induced by
[cited by applicant]
Al-Eidan et al., “ClostIidium difficile-associated diarrhoea in hospitalised patients,”
[cited by applicant]
Al-Nassir et al., “Comparison of Clinical and Microbiological Response to Treatment of Clostridium difficile-Associated Disease with Metronidazole and Vancomycin,”
[cited by applicant]
Anand et al., “Epidemiology, clinical manifestations, and outcome of Clostridium difficile-associated diarrhea,”
[cited by applicant]
Ananthakrishnan et al., “Excess hospitalisation burden associated with Clostridium difficile in patients with inflammatory bowel disease,”
[cited by applicant]
Anderson et al., “Systematic review: faecal microbiota transplantation in the management of inflammatory bowel disease,”
[cited by applicant]
Andoh et al., “Terminal restliction fragment polymorphisum analyses of fecal microbiota in five siblings including two with ulcerative colitis,”
[cited by applicant]
Andrews et al., “‘Putting back the bugs’: Bacterial Treatment Relieves Chronic Constipation and Symptoms of Irritable Bowel Syndrome,”
[cited by applicant]
Andrews et al., “Bacteriotherapy for Chronic Constipation—A Long Term Follow-Up,”
[cited by applicant]
Andrews et al., “Chronic Constipation (CC) may be reversed by Bacteriotherapy,”
[cited by applicant]
Andrews et al., “Chronic constipation reversed by restoration of bowel flora. A case and a hypothesis,”
[cited by applicant]
Anorexia nervosa, Encyclopedia Index A, health AtoZ, Medical Network, Inc., pp. 1-7, n.d., Web, Nov. 23, 2005 <http://www.healthatoz.com/healthatoz/Atoz/ency/anorexia_nervosa.jsp>.
[cited by applicant]
Arkkila et al., “Fecal Bacteriotherapy for Recurrent
[cited by applicant]
Aroniadis et al., “Intestinal Microbiota and the Efficacy of Fecal Microbiota Transplantation in Gastrointestinal Disease,” Gastroenterology and Hepatology, 10(4): 230-7 (2014).
[cited by applicant]
Aroniadis et al., “Long-Term Follow-up Study of Fecal Microbiota Transplantation (FMT) for Severe or Complicated
[cited by applicant]
Atarashi et al., “Induction of Colonic Regulatory T Cells by Indigenous
[cited by applicant]
Atarashi et al., “T
[cited by applicant]
Atarashi et al., “WS/PP-064-03 Regulation of colonic regulatory T cells by
[cited by applicant]
Atarashi et al., WS-064 Mucosal immunity: homeostasis, 14thICIC Abstractbook, 14th International Congress of Immunology, pp. iii131-iii133 (2010).
[cited by applicant]
Autism, Health Encyclopedia—Diseases and Conditions, The Health Scout Network, pp. 1-5, n.d., Web, Nov. 22, 2005 <www.healthscout.com>.
[cited by applicant]
Autism, Treatment, Prognosis, Healthcommunitiescom, Inc., pp. 1-4, n.d., Web. Jan. 28, 2009 <http://www.neurologychannel.com/common/PrintPage.php>.
[cited by applicant]
Autism: Mayo Clinic.com, Mayo Foundation for Medical Education and Research, pp. 1-7, May 31, 2008, Web. Jan. 28, 2009 21 http://www.mayocliniccom/print/autism/DS00348/METHOD=print&DSECTION=all>.
[cited by applicant]
Backhed et al., “Host-bacterial mutualism in the human intestine,”
[cited by applicant]
Backhed et al., “Mechanisms underlying the resistance to diet-induced obesity in germ-free mice,”
[cited by applicant]
Backhed et al., “The gut microbiota as an environmental factor that regulates fat storage,”
[cited by applicant]
Bakken et al., “Fecal bacteriotherapy for recurrent Clostridium difficile infection,”
[cited by applicant]
Bakken et al., “Treating Clostridium difficile Infection with Fecal Microbiota Transplantation,”
[cited by applicant]
Bartlett et al., “Clinical recognition and diagnosis of Clostridium difficile infection,”
[cited by applicant]
Bartlett, “Clostridium difficile-associated Enteric Disease,”
[cited by applicant]
Belkaid et al., “Natural regulatory T cells in infectious disease,”
[cited by applicant]
Bengmark et al., “Bioecological control of inflammatory bowel disease,”
[cited by applicant]
Bennet et al., “Treatment of ulcerative colitis by implantation of normal colonic flora,”
[cited by applicant]
Benson et al., “Changing epidemiology of Clostlidium difficile-associated disease in children,”
[cited by applicant]
Bergey's Manual of Systematic Bacteriology, Second Edition, vol. Three, The Firmicutes, pp. 1-16 (2009).
[cited by applicant]
Blaser et al., “What are the consequences of the disappearing human microbiota?”
[cited by applicant]
Blaser, “Who are we? Indigenous microbes and the ecology of human diseases,”
[cited by applicant]
Bolte, “Autism and Clostridium tetani,” Medical Hypotheses, 51(2):133-144 (1998).
[cited by applicant]
Bolte, Therapies for Gastrointestinal and Neurological Disorders, U.S. Appl. No. 60/214,813, filed Jun. 28, 2000.
[cited by applicant]
Borody et al., “Fecal microbiota transplantation in gastrointestinal disease: 2015 update and the road ahead,” Expert Review of Gastroenterology and Hepatology, 9(11):1379-1391 (2015).
[cited by applicant]
Borody et al., “Anti-MAP Rescues Anti-TNF Failures for Over 4 Years,”
[cited by applicant]
Borody et al., “Anti-MAP Therapy for Pediatric Crohn's Disease,”
[cited by applicant]
Borody et al., “Anti-MAP Therapy in the Treatment of Active Crohn's Disease,”
[cited by applicant]
Borody et al., “Anti-mycobactelial therapy in Crohn's disease heals mucosa with longitudinal scars,”
[cited by applicant]
Borody et al., “Anti-
[cited by applicant]
Borody et al., “Bacteriotherapy in Chronic Fatigue Syndrome (CFS): A retrospective review,”
[cited by applicant]
Borody et al., “Bacteriotherapy Using Fecal Flora: toying with human motions”
[cited by applicant]
Borody et al., “Bowel-flora alteration: a potential cure for inflammatory bowel disease and irritable bowel syndrome?”
[cited by applicant]
Borody et al., “Changes in Crohn's Disease Activity Index and C-Reactive Protein Levels During Anti-MAP Therapy,”
[cited by applicant]
Borody et al., “Clostridium difiicile Complicating Inflammatory Bowel Disease: Pre- and Post-Treatment Findings,”
[cited by applicant]
Borody et al., “Could fecal microbiota transplantation cure all Clostridium difficile infections?,”
[cited by applicant]
Borody et al., “Entamoeba
[cited by applicant]
Borody et al., “Faecal bacteriotherapy (FB) for chronic
[cited by applicant]
Borody et al., “Fecal bacteriotherapy in the treatment of recurrent C. difficile infection,”
[cited by applicant]
Borody et al., “Fecal Microbiota Transplantation (FMT) in Multiple Sclerosis (MS),”
[cited by applicant]
Borody et al., “Fecal microbiota transplantation and emerging applications,”
[cited by applicant]
Borody et al., “Fecal microbiota transplantation for
[cited by applicant]
Borody et al., “Fecal microbiota transplantation in gastrointestinal diseases—What practicing physicians should know,”
[cited by applicant]
Borody et al., “Fecal microbiota transplantation in the treatment of recurrent Clostridium difficile infection,”
[cited by applicant]
Borody et al., “Fecal Microbiota Transplantation in Ulcerative Colitis: Review of 24 Years Experience,”
[cited by applicant]
Borody et al., “Fecal microbiota transplantation: a new standard treatment option for
[cited by applicant]
Borody et al., “Fecal microbiota transplantation: current status and future directions,”
[cited by applicant]
Borody et al., “Fecal Microbiota Transplantation: Expanding Horizons for
[cited by applicant]
Borody et al., “Fecal Microbiota Transplantation: Indications, Methods, Evidence, and Future Directions,”
[cited by applicant]
Borody et al., “Fecal Microbiota Transplantation: Techniques, Applications, and Issues,”
[cited by applicant]
Borody et al., “Irritable Bowel Syndrome and
[cited by applicant]
Borody et al., “Is Crohn's Disease Ready for Fecal Microbiota Transplantation?,”
[cited by applicant]
Borody et al., “Myoclonus-dystonia affected by GI Microbiota?,”
[cited by applicant]
Borody et al., “Novel appearance of healing mucosa following anti-
[cited by applicant]
Borody et al., Reversal of Idiopathic Thrombocytopenic Purpura [ITP] with Fecal Microbiota Transplantation [FMT],
[cited by applicant]
Borody et al., “Reversal of Inflammatory Bowel Disease (IBD) with Recurrent Faecal Microbiota Transplants (FMT),”
[cited by applicant]
Borody et al., “Severe recurrent Crohn's Disease of ileocolonic anastomosis and antimicrobial (anti-mycobacterial therapy),”
[cited by applicant]
Borody et al., “The GI Microbiome and its Role in Chronic Fatigue Syndrome: a Summary of Bacteriotherapy,” ACNEM Journal, 31(3):3-8 (2012).
[cited by applicant]
Borody et al., “Therapeutic faecal microbiota transplantation: current status and future developments,”
[cited by applicant]
Borody et al., “Treatment of chronic constipation and colitis using human probiotic infusions,”
[cited by applicant]
Borody et al., “Treatment of First-time Clostridium difficile Infection with Fecal Microbiota Transplantation,” Poster Presentation,
[cited by applicant]
Borody et al., “Treatment of Severe Constipation Improves Parkinson's Disease (PD) Symptoms,”
[cited by applicant]
Borody et al., “Treatment of Severe Crohn's Disease (CD)—Using Rifabutin-Macrolide-Clofazimine Combination: Results at 30-37 Months,”
[cited by applicant]
Borody et al., Treatment of Severe Crohn's Disease Using Rifabutin-Macrolide-Clofazimine Combination—Results at 38-43 Months,
[cited by applicant]
Borody et al., “Treatment of Severe Crohn's disease using antimycobacterial triple therapy—approaching a cure?,”
[cited by applicant]
Borody et al., “Treatment of ulcerative colitis using fecal bacteriotherapy,”
[cited by applicant]
Borody, “Bacteriotherapy for Chronic Fatigue Syndrome—A Long Term Follow-Up Study,” Proceedings of ACMA Complementary Medicine Sydney, p. 1 (1995).
[cited by applicant]
Borody, “Flora Power”—Fecal Bacteria Cure Chronic C. difficile Diarrhoea,
[cited by applicant]
Borody, “Is the Infected Patient too ‘Difficile’ to Treat?,” The Australian Society for Microbiology 2009 Perth, SY03 & SY03. 1, p. 27 & 56, (2009).
[cited by applicant]
Borody, “Letter to the Editor—Response to Drs. Famularo et al.,”
[cited by applicant]
Borliello, “Clostridial Disease of the Gut,” Clinical Infectious Diseases, The University of Chicago, 20(Suppl 2):S242-S250 (1995).
[cited by applicant]
Bowden et al., “Pseudomembraneous enterocolitis: mechanism of restoring floral homeostasis,”
[cited by applicant]
Brandt et al., “Endoscopic Fecal Microbiota Transplantation: “First-Line” Treatment for Severe Clostridium difficile Infection?”
[cited by applicant]
Brandt et al., “Fecal microbiota transplantation for recurrent
[cited by applicant]
Brandt et al., “Long-Term Follow-Up Study of Fecal Microbiota Transplantation (FMT) for Ulcerative Colitis (UC),” Am J. Gastroenterol., 107(Suppl 1):S657 (2012).
[cited by applicant]
Brandt et al., Safety of Fecal Microbiota Transplantation (FMT) in Immunocompromised (le) Patients with Inflammatory Bowel Disease (IBD),
[cited by applicant]
Browne et al., “Culturing of ‘unculturable’ human microbiota reveals novel taxa and extensive sporulation,”
[cited by applicant]
Bueche et al., “Quantification of Endospore-Forming Firmicutes by Quantitative PCR with the Functional Gene spo0A,”
[cited by applicant]
Cammarota et al., “Randomised clinical trial: faecal microbiota transplantation by colonoscopy vs. vancomycin for the treatment of recurrent Clostridium difficile infection,” Alimentary Pharmacology & Therapeutics, 41(9…
[cited by applicant]
Cammorata et al., “Review article: biofile formation by Helicobacter pylori as a target for eradication of resistant infection,” Aliment Phannacol Ther, 36:222-30 (2012).
[cited by applicant]
Campbell et al., “The many faces of Crohn's Disease: Latest concepts in etiology,”
[cited by applicant]
Cano et al., “Revival and identification of bacterial spores in 25-40 million year old Dominican Amber Science,” Science, 268(5213):1060-1064 (1995).
[cited by applicant]
Cato et al., “
[cited by applicant]
Celik et al., “Factors influencing the stability of freeze-dried stress-resilient and stress-sensitive strains of bifidobacteria,” J. Dairy Sci, 96(6):3506-16 (2013).
[cited by applicant]
Center for Disease Control, “Severe Clostridium difficile-associated disease in populations previously at low risk-four states, 2005.”
[cited by applicant]
Chamberlain et al., “MAP-associated Crohn's Disease, MAP, Koch's postulates, causality and Crohn's Disease,”
[cited by applicant]
Chamberlin et al., “Primary treatment of Crohn's disease: combined antibiotics taking center stage,”
[cited by applicant]
Chang et al., “Decreased diversity of the fecal Microbiome in recurrent Clostridium difficile-associated diarrhea,”
[cited by applicant]
Chen et al., “A mouse model of Clostridium difficile-associated disease,”
[cited by applicant]
Cherif et al., “Thuricin 7: a novel bacteriocin produced by Bacillus thuringiensis BMG1.7, a new strain isolated from soil,” Letters in Applied Microbiology, 32:243-7 (2001).
[cited by applicant]
Chibani-Chennoufi et al., “In Vitro and In Vivo Bacteriolytic Activities of
[cited by applicant]
Choi et al., “Fecal Microbiota Transplantation: Current Applications, Effectiveness, and Future Perspectives,” Clin. Endosc, 49:257-265 (2016).
[cited by applicant]
Chopra et al., “Recent epidemiology of Clostlidium difficile infection during hematopoietic stem cell transplantation,”
[cited by applicant]
Chu et al., “Profiling Living Bacteria Informs Preparation of Fecal Microbiota Transplantations,”
[cited by applicant]
Citron et al., “In Vitro Activities of CB-183,315, Vancomycin, and Metronidazole against 556 Strains of
[cited by applicant]
Claesson et al., “Comparison of two next-generation sequencing technologies for resolving highly complex microbiota composition using tandem variable 16S rRNA gene regions,”
[cited by applicant]
Clancy et al., “Anti-MAP Therapy Induces and Maintains Remission in Severe Crohn's Disease,”
[cited by applicant]
Claus et al., “Colonization-induced host-gut microbial metabolic interaction,”
[cited by applicant]
Claus et al., “Systemic multicompartmental effects of the gut microbiome on mouse metabolic phenotypes,”
[cited by applicant]
Cohen et al., “Clinical practice guidelines for Clostridium difficile infection in adults: 2010 update by the society for healthcare epidemiology of America (SHEA) and the infectious diseases society of America (IDSA),”
[cited by applicant]
Collins et al., “The Phylogeny of the Genus
[cited by applicant]
U.S. Appl. No. 12/843,409, filed Jul. 26, 2010.
[cited by applicant]
Crohn's Disease, Prevention, Health Guide A-Z, WebMDHealth, pp. 1-2, n.d., Web, Oct. 23, 2005 <http://mywebmd.com/hw/inflammatory.sub.--bowel/uf6012.asp>.
[cited by applicant]
Crowther, “Transport and Storage of Faeces for Bacteriological Examination,” Journal of Applied Bacteriology, 34(2):477-483 (1971).
[cited by applicant]
Cutolo et al., “Fecal feedings as a therapy in
[cited by applicant]
Dale et al., “Molecular interactions between bacterial symbionts and their hosts,”
[cited by applicant]
Dan et al., “Comparison of preservation media and freezing conditions for storage of specimens of faeces,” J. Med Microbiology, 28:151-154 (1989).
[cited by applicant]
De Giulio et al., “Use of Alginate and Cryo-Protective Sugars to Improve the Viability of Lactic Acid Bacteria After Freezing and Freeze-Drying,” World Journal of Microbiology & Biotechnology, 21:739-746 (2005).
[cited by applicant]
Defang et al., “In Vitro and in Vivo evaluation of two extended release preparations of combination metforrnin and glipizide,”
[cited by applicant]
Definition of Kit, Merriam-Webster, pp. 1-10., Web., 2019 <https://www.merriam-webster.com/dictionary/kit>.
[cited by applicant]
Dendukuri et al., “Probiotic therapy for the prevention and treatment of Clostridium difficile-associated diarrhea: a systematic review,”
[cited by applicant]
Derwent Abstract Accession No. 98-230427/20, WO 98/13068 A, (Kuperman VB) Apr. 2, 1998.
[cited by applicant]
Dethlefsen et al., “An ecological and evolutionary perspective on human-microbe mutualism and disease,”
[cited by applicant]
Dewhirst et al., “Phylogeny of the Defined Murine Microbiota: Altered Schaedler Flora,”
[cited by applicant]
DuPont, “The search for effective treatment of Clostiidium difficile infection,”
[cited by applicant]
Eckburg et al., “Diversity of the human intestinal microbial flora,”
[cited by applicant]
Eiseman et al., “Fecal enema as an adjunct in the treatment of pseudomembranous enterocolitis,”
[cited by applicant]
Eller et al., “Anaerobic Roll Tube Media for Nonselective Enumeration and Isolation and Bacteria in Human Feces,” Applied Microbiology, 22(4):522-529 (1971).
[cited by applicant]
Extended European Search Report dated Apr. 3, 2014, in European Patent Application No. 11813951.8.
[cited by applicant]
Extended European Search Report dated Mar. 16, 2018, in European Patent Application No. 17203052.0.
[cited by applicant]
Extended European Search Report dated Nov. 30, 2016, in European Patent Application No. 16193790.9.
[cited by applicant]
Faust et al., “Treatment of recurrent pseudomembranous colitis (RPMC) with stool transplantation (ST): Report of six (6) cases,”
[cited by applicant]
Fenton et al., “Pseudomembranous colitis associated with antibiotic therapy—an emerging entity,”
[cited by applicant]
Floch et al., “Probiotics and Dietary Fiber, The Clinical Coming of Age of Intestinal Microecology,” J. Clin. Gastroenterology, 27(2):99-100 (1998).
[cited by applicant]
Floch, “Fecal Bacteriotherapy, Fecal Transplant, and the Microbiome,” J. Clin. Gastroenterol., 44(8):529-530 (2010).
[cited by applicant]
Flotterod et al., “Refractory Clostridium difficile infection. Untraditional treatment of antibiotic-induced colitis,”
[cited by applicant]
Frank et al., “Molecular-phylogenetic characterization of microbial community imbalances in human inflammatory bowel diseases,”
[cited by applicant]
Frantzen et al., “Empirical evaluation of preservation methods for faecal DNA,”
[cited by applicant]
Freeman et al., “The changing epidemiology of Clostlidium difficile infections,”
[cited by applicant]
Frese et al., “The evolution of host specialization in the vertebrate gut symbiont Lactobacillus reuteri,”
[cited by applicant]
Gaboriau-Routhiau et al., “The Key Role of Segmented Filamentous Bacteria in the Coordinated Maturation of Gut Helper T Cell Responses,”
[cited by applicant]
Garborg et al., “Results of faecal donor instillation therapy for recurrent Clostridiurn difficile-associated diarrhoea,”
[cited by applicant]
Garey et al., “Meta-analysis to assess risk factors for recurrent Clostridium difficile infection,”
[cited by applicant]
Gerding, “Management of Clostridium difficile infection: thinking inside and outside the box,”
[cited by applicant]
Geuking et al., “Intestinal Bacterial Colonization Induces Mutualistic Regulatory T Cell Responses,”
[cited by applicant]
Gitlin et al., “
[cited by applicant]
Gough et al., “Systematic review of intestinal microbiota transplantation (fecal bacteriotherapy) for recurrent Clostridium difficile infection,”
[cited by applicant]
Grehan et al., “Durable alteration of the colonic microbiota by the administration of donor fecal flora,”
[cited by applicant]