US 12,186,349 B2
Compositions and methods for C. difficile treatment
Matthew J. Hamilton, Burnsville, MN (US); Alexander Khoruts, Golden Valley, MN (US); Michael J. Sadowsky, Roseville, MN (US); and Christopher M. Staley, Saint Paul, MN (US)
Assigned to REGENTS OF THE UNIVERSITY OF MINNESOTA, Minneapolis, MN (US)
Filed by REGENTS OF THE UNIVERSITY OF MINNESOTA, Minneapolis, MN (US)
Filed on Oct. 12, 2023, as Appl. No. 18/485,872.
Application 18/485,872 is a continuation of application No. 17/098,243, filed on Nov. 13, 2020, granted, now 11,819,523.
Application 17/098,243 is a continuation of application No. 16/313,791, granted, now 10,849,936, issued on Dec. 1, 2020, previously published as PCT/US2017/040591, filed on Jul. 3, 2017.
Claims priority of provisional application 62/357,814, filed on Jul. 1, 2016.
Prior Publication US 2024/0050489 A1, Feb. 15, 2024
This patent is subject to a terminal disclaimer.
Int. Cl. A61K 35/74 (2015.01); A01N 1/02 (2006.01); A61K 9/00 (2006.01); A61K 9/16 (2006.01); A61K 9/19 (2006.01); A61K 9/20 (2006.01); A61K 31/43 (2006.01); A61P 31/04 (2006.01)
CPC A61K 35/74 (2013.01) [A01N 1/02 (2013.01); A61K 9/0053 (2013.01); A61K 9/1623 (2013.01); A61K 9/1682 (2013.01); A61K 9/19 (2013.01); A61K 9/2095 (2013.01); A61K 31/43 (2013.01); A61P 31/04 (2018.01)] 20 Claims
 
1. A method for treating or clearing a Clostridium difficile infection (CDI) in a subject in need thereof, the method comprising administering to the subject a single dose of a pharmaceutical composition comprising a freeze-dried fecal microbe preparation derived from a stool of a healthy human donor, wherein (a) a relative abundance of Proteobacteria in the subject's stool decreases by at least 40%, (b) a relative abundance of Firmicutes in the subject's stool increases by at least 50%, or (c) a relative abundance of Bacteroidetes in the subject's stool increases by at least 50%, within 3 to 6 days from administering the single dose relative to a baseline abundance immediately prior to administering the single dose, wherein the method achieves a CDI clearance rate as determined by the absence of detectable C. difficile toxin B DNA in the stool of the subject.