IP Library Granted Patent US 11,351,208
Granted Patent B2
US 11,351,208 · App. 16/979,824 · Granted Jun 7, 2022

Altering the intestinal microbiome in cystic fibrosis

Inventors: George A. O'Toole (Hanover, NH); Juliette C. Madan (Lyme, NH)
Assignees: Trastees of Dartmouth College; Dartmouth-Hitchcock Clime
A61K35/745A61K35/741A61K35/744A61K45/06A61P1/00A61P11/00
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Quick Facts
Patent No.
US 11,351,208
App. No.
16/979,824
Granted
Jun 7, 2022
Kind
B2
Abstract

The present disclosure relates to a method of altering intestinal microbiome in a patient having cystic fibrosis comprising administering at least one of Bifidobacterium and/or Bacteroides to a patient and allowing the Bifidobacterium and/or Bacteroides to alter the intestinal microbiome.

Claims (26)

1. A method of altering the intestinal microbiome in a patient diagnosed with cystic fibrosis, wherein the patient is 0 days to 12 months old and has a relative abundance of intestinal Bacteroides of not more than 20%, the method comprising:

administering Bacteroides to the patient's gastrointestinal tract and allowing the Bacteroides to alter the intestinal microbiome, wherein altering the intestinal microbiome reduces the risk of, reduces the severity of, or delays the onset of a pulmonary infection or pulmonary exacerbation.

2. The method of claim 1 , further comprising administering Bifidobacterium to the patient and allowing the Bifidobacterium to alter the intestinal microbiome.

3. The method of claim 1 , wherein the method further comprises administering Streptococcus.

4. The method of claim 1 , further comprising administering Ruminococcus to the patient and allowing the Ruminococcus to alter the intestinal microbiome.

5. The method of claim 1 , wherein the pulmonary infection is selected from the group consisting of Staphylococcus aureus infection, Pseudomonas aeruginosa infection, Stenotrophomonas infection, Streptococcus infection, Haemophilus influenzae infection, nontuberculous mycobacterium infection, Burkholderia cepacia complex infection, viral infection, and a co-infection with multiple pathogens.

6. A method of preventing, delaying the onset, reducing the severity, and/or reducing the duration of a pulmonary infection by a pathogen, or an exacerbation thereof, in a patient in need thereof, the method comprising:

administering Bacteroides to the patient's gastrointestinal tract, wherein prior to said administration a fecal sample from the patient has been tested to determine a level of Bacteroides in the patient's gastrointestinal tract wherein the patient is 0 days old to 3 years old.

7. The method of claim 6 , wherein the pathogen is P. aeruginosa.

8. The method of claim 6 , wherein the patient is 1 week old to 12 months old or 1 week old to 6 months old.

9. The method of claim 6 , wherein the patient is a cystic fibrosis patient.

10. The method of claim 6 , wherein the fecal sample has a relative abundance of Bacteroides of not more than 20%.

11. The method of claim 6 , wherein the fecal sample has a relative abundance of Bacteroides of ≤1%.

12. The method of claim 11 , wherein the patient is not a cystic fibrosis patient.

13. The method of claim 6 , wherein the Bacteroides is orally administered to the patient.

14. The method of claim 1 , wherein the Bacteroides is orally administered to the patient.

15. The method of claim 1 , wherein the relative abundance of intestinal Bacteroides in the patient is ≤1%.

16. A method of preventing, delaying the onset, reducing the severity, and/or reducing the duration of a pulmonary infection by a pathogen in a patient, the method comprising:

obtaining a fecal sample from the patient;

testing the fecal sample to determine a level of Bacteroides , wherein a relative abundance of Bacteroides of not more than 20% indicates that the patient is at risk for a pulmonary infection;

administering Bacteroides to the patient's gastrointestinal tract.

17. The method of claim 16 , wherein the patient is not a cystic fibrosis patient.

18. The method of claim 17 , wherein the Bacteroides is orally administered to the patient.

19. The method of claim 16 , wherein the patient is a cystic fibrosis patient.

20. The method of claim 19 , wherein the Bacteroides is orally administered to the patient.

21. The method of claim 20 , wherein the method further comprises administering at least one cystic fibrosis therapy to the patient, wherein the cystic fibrosis therapy comprises (i) at least one pancreatic enzyme replacement product; (ii) at least one probiotic; (iii) at least one prebiotic; (iv) at least one antibiotic; (v) at least one anti-inflammatory medication; (vi) at least one mucus-thinning drug; (vii) at least one cystic fibrosis transmembrane conductance regulator (CFTR) function-improving medication; or (viii) at least one bronchodilator or inhaled medication.

Assignments (3)
CONFIRMATORY LICENSE Recorded Oct 17, 2023
From: DARTMOUTH COLLEGE
To: NATIONAL INSTITUTES OF HEALTH (NIH), U.S. DEPT. OF HEALTH AND HUMAN SERVICES (DHHS), U.S. GOVERNMENT
Reel/Frame 065256/0651 →
ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded Nov 17, 2021
From: O'TOOLE, GEORGE A.
To: TRUSTEES OF DARTMOUTH COLLEGE
Reel/Frame 058144/0524 →
ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded Sep 10, 2020
From: MADAN, JULIETTE C.
To: TRUSTEES OF DARTMOUTH COLLEGE; DARTMOUTH-HITCHCOCK CLINIC
Reel/Frame 053739/0389 →
Continuity (2)
Provisional Application 62649230 · Mar 28, 2018
Related Publication 20210228655A1 · Jul 29, 2021