IP Library Granted Patent US 10,357,521
Granted Patent B2
US 10,357,521 · App. 15/155,675 · Granted Jul 23, 2019

Methods for restoring microbiota of newborns

Inventor: Maria Gloria Dominguez-Bello (New York, NY)
Assignees: University of Puerto Rico; New York University
A61K35/747A61K35/741A61K35/742A61K35/745
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Quick Facts
Patent No.
US 10,357,521
App. No.
15/155,675
Granted
Jul 23, 2019
Kind
B2
Abstract

The invention relates to methods and compositions for restoring normal microbiota in pre-term newborns or newborns delivered by Cesarean section and methods for preventing or ameliorating diseases associated with delivery by Cesarean section or pre-term birth comprising administering to said newborns at the time of birth or shortly thereafter an effective amount of a vaginal microbiota inoculum obtained from the newborn's mother or a donor or an effective amount of a probiotic composition.

Claims (14)

1. A method for restoring normal microbiota in an infant delivered by Cesarean section, said method comprising administering an effective amount of bacterial strains from Bacteroides, Lactobacillus , and Gemella as one or more probiotic compositions to said infant at the time of birth and/or within the first 4 months of life, wherein said one or more probiotic compositions (i) stimulate growth and/or activity of bacteria which are under-represented in microbiota of said infant as compared to vaginally delivered full-term infants, and/or (ii) inhibit growth and/or activity of bacteria which are over-represented in microbiota of said infant as compared to vaginally delivered full-term infants.

2. The method of claim 1 , further comprising administering an effective amount of one or more bacterial strains from one or more taxa selected from the group consisting of Bifidobacterium, Bacteriodales, Parabacteroides, Bacteroidacea, Porphyromonadaceae, Coriobacteriales , Clostridiaceae, Enterobacteriaceae, and Stenotrophomonas.

3. The method of claim 1 , further comprising administering one or more bacterial strains from one or more taxa recited in Table 1A.

4. The method of claim 1 , further comprising administering one or more bacterial strains from one or more species recited in Table 1B.

5. The method of claim 1 , further comprising administering one or more bacterial strains which can be found in a healthy vaginal microbiota from a pregnant woman in the third trimester of pregnancy before or at the time of giving birth.

6. The method of claim 1 , wherein said one or more probiotic compositions further comprise one or more components selected from the group consisting of live bacterial cells, conditionally lethal bacterial cells, inactivated bacterial cells, killed bacterial cells, spores, recombinant carrier strains, cell extract, and bacterially-derived products.

7. The method of claim 1 , wherein said one or more probiotic compositions comprise (i) a carrier and/or excipient and/or (ii) one or more prebiotic agents which stimulate growth and/or activity of one or more bacteria present in the composition.

8. The method of claim 1 , wherein said one or more probiotic compositions are delivered to the infant in a form of a liquid, foam, cream, spray, powder, or gel.

9. The method of claim 1 , further comprising monitoring the infant's microbiota after the administration of the probiotic composition(s) by:

(a) determining a relative abundance of one or more bacterial taxa in a microbiota sample obtained from the infant, and

(b) comparing the relative abundance(s) determined in step (a) to (i) a predetermined standard value or (ii) to the abundance(s) of the same taxa in a control subject or (iii) to the average value of abundances of the same taxa in several control subjects.

10. The method of claim 9 , wherein said one or more probiotic compositions are delivered to the infant in a form of a liquid, foam, cream, spray, powder, or gel.

11. The method of claim 9 , wherein the control subject is a vaginally delivered full-term healthy infant.

12. The method of claim 1 , further comprising administering an effective amount of one or more bacterial strains from the family Porphyromonadaceae.

Assignments (2)
ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded Jul 17, 2019
From: DOMINGUEZ-BELLO, MARIA GLORIA
To: UNIVERSITY OF PUERTO RICO; NEW YORK UNIVERSITY
Reel/Frame 049782/0716 →
CONFIRMATORY LICENSE Recorded Mar 30, 2017
From: NEW YORK UNIVERSITY
To: NATIONAL INSTITUTES OF HEALTH (NIH), U.S. DEPT. OF HEALTH AND HUMAN SERVICES (DHHS), U.S. GOVERNMENT
Reel/Frame 041791/0626 →
Continuity (2)
Provisional Application 62161549 · May 14, 2015
Related Publication 20160331792A1 · Nov 17, 2016