IP Library Granted Patent US 12,653,848
Granted Patent B2
US 12,653,848 · App. 18/246,495 · Granted Jun 16, 2026

Fecal matter for preventing or treating intestinal microbiome aberrations in cesarean section-born infants

Inventors: Willem Meindert De Vos (Amsterdam, NL); Lucas Gerardus Willibrordus Sterkman (Heiloo, NL)
Assignee: CAELUS PHARMACEUTICALS B.V.
A61K35/745A61K35/24A61P1/00
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Quick Facts
Patent No.
US 12,653,848
App. No.
18/246,495
Granted
Jun 16, 2026
Kind
B2
Abstract

A composition for use in the prevention or treatment of intestinal microbiota aberration in a Cesarean section- (CS-) born infant, wherein the use is particularly for one or more of reducing intestinal colonization of pathogenic microorganisms, increasing intestinal relative abundance of Bacteroides species and/or Bifidobacterium species, increasing intestinal microbial diversity, increasing level of intestinal secretory IgA and/or intestinal antimicrobial peptides, reducing susceptibility to a disorder particularly chosen from the group consisting of metabolic disease, obesity, type 2 diabetes, auto-immune disease, atopy-related disease, allergy and asthma, and increasing immune response to vaccines.

Claims (33)

1 . A method of increasing immune response to a vaccine in a Cesarean section- (CS-) born infant, the method comprising:

administering to the CS-born infant a composition comprising:

(a) at least one Bacteroides species; and

(b) at least one Bifidobacterium species,

in combination with administering to the CS-born infant a vaccine, wherein the composition increases the infant's immune response to the vaccine.

2 . The method according to claim 1 , wherein the composition comprises at least one Akkermansia species.

3 . The method according to claim 2 , wherein the vaccine is a vaccine against invasive disease caused by Streptococcus pneumoniae.

4 . The method according to claim 1 , wherein the method reduces intestinal colonization of pathogenic microorganisms selected from the group consisting of Enterococcus species, Enterococcus faecium, Enterococcus faecalis, Enterobacter species, Enterobacter cloacae, Klebsiella species, Klebsiella pneumonia, Klebsiella oxytoca, Haemophilus influenza, Campylobacter jejuni , and Salmonella enterica.

5 . The method according to claim 1 , wherein the method increases intestinal relative abundance of Bacteroides species and/or increases intestinal relative abundance of Bifidobacterium species and/or decreases intestinal relative abundance of Clostridium species.

6 . The method according to claim 1 , wherein the method reduces susceptibility to a disorder selected from the group consisting of metabolic or immune disease, obesity, type 2 diabetes, chronic inflammatory disease, inflammatory bowel disease, Crohn's disease, ulcerative colitis, irritable bowel syndrome, auto-immune disease, type 1 diabetes, rheumatoid autoimmune disease, rheumatoid arthritis, Bechterew's disease, thyroid autoimmune disease, Hashimoto's disease, Graves' disease, Addison's disease, psoriasis, vitiligo, celiac disease, systemic connective disorder, systemic lupus erythematosus, atopy-related disease, allergy, and asthma.

7 . The method according to claim 1 , wherein the method increases levels of intestinal secretory IgA and/or increases levels of intestinal antimicrobial peptides.

8 . The method according to claim 1 , wherein the method increases intestinal microbial diversity as may be measured by increased inverse Simpson diversity index.

9 . The method according to claim 1 , wherein the composition is fecal matter obtained from at least one donor subject.

10 . The method according to claim 9 , wherein the at least one donor subject is the CS-born infant's mother.

11 . The method according to claim 10 , wherein the fecal matter is obtained from the mother of the CS-born infant at most five (5) weeks prior to the CS.

12 . The method according to claim 10 , wherein the fecal matter is obtained from the mother of the CS-born infant at most three (3) weeks prior to the CS.

13 . The method according to claim 9 , wherein the method includes:

determining in a sample of one or more subjects of one or more of group B Streptococcus , human immunodeficiency virus (HIV), SARS-COV-2 (COVID-19), human T-cell lymphotropic virus, Treponema pallidum; Treponema pallidum , hepatitis A, B, C, and E, protozoa, helminths, Entamoeba histolytica, Clostridium difficile , enteric pathogens, Salmonella, Shigella, Campylobacter, Vibrio cholera , pathogenic Escherichia coli strains, EHEC, ETEC, EPEC, EIEC, EAEC, Helicobacter pylori , Norovirus, Giardia lamblia, Cryptosporidium parvum , methicillin-resistant Staphylococcus aureus (MRSA), Gram-negative multidrug-resistant (MDR) bacteria and vancomycin-resistant enterococci (VRE); and

subsequent selection of one or more donor subjects not carrying one or more of group B Streptococcus , human immunodeficiency virus (HIV), human T-cell lymphotropic virus, Treponema pallidum , hepatitis A, B, C, and E, protozoa, helminths, Entamoeba histolytica, Clostridium difficile , enteric pathogens, Salmonella, Shigella, Campylobacter, Vibrio cholera , pathogenic Escherichia coli strains, EHEC, ETEC, EPEC, EIEC, EAEC, Helicobacter pylori , Norovirus, Giardia lamblia, Cryptosporidium parvum , methicillin-resistant Staphylococcus aureus (MRSA), Gram-negative multidrug-resistant (MDR) bacteria and vancomycin-resistant enterococci (VRE).

14 . The method according to claim 9 , wherein the method includes:

determining antibiotic use of one or more subjects; and

subsequent selection of one or more donor subjects not having used antibiotics in the preceding month.

15 . The method according to claim 9 , wherein the method includes:

determining antibiotic use of one or more subjects; and

selecting one or more donor subjects not having used antibiotics in the preceding six (6) months.

16 . The method according to claim 1 , wherein the composition comprises between 0.1-5 mg fecal matter and/or wherein the composition comprises between 1×10 5 and 1×10 8 bacterial cells.

17 . The method according to claim 1 , wherein the composition comprises between 0.1-2.9 mg fecal matter obtained from the mother, father, grandmother, and/or grandfather of the CS-born infant.

18 . The method according to claim 1 , wherein the composition is comprised in breast milk or pasteurized bank milk and/or administered to the CS-born infant within, at most, twenty-four (24) hours of CS.

19 . The method according to claim 1 , wherein the infant is a mammal.

20 . The method according to claim 1 , wherein the infant is a human.

21 . The method according to claim 1 , wherein the composition is administered to the CS-born infant within, at most, four (4) hours of CS.

22 . The method according to claim 1 , wherein the vaccine is a vaccine selected from the group consisting of vaccines against measles, mumps, rubella, diphtheria, tetanus, pertussis, poliomyelitis, Haemophilus influenzae type B, human papillomavirus, hepatitis A, influenza, invasive disease caused by Neisseria meningitidis , invasive disease caused by Streptococcus pneumoniae , rotavirus, tuberculosis, and varicella.

23 . The method according to claim 1 , wherein the increased immune response to the vaccine is as measured by increased level of antigen specific antibodies in a blood sample of the CS-born infant.

Assignments (2)
ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded Dec 29, 2025
From: CAELUS PHARMACEUTICALS B.V.
To: CAELUS LIFESCIENCES IP B.V.
Reel/Frame 073329/0457 →
ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded Apr 10, 2023
From: DE VOS, WILLEM MEINDERT; STERKMAN, LUCAS GERARDUS WILLIBRORDUS
To: CAELUS PHARMACEUTICALS B.V.
Reel/Frame 063273/0409 →
Priority Claims (1)
NL 2026545 · Sep 25, 2020 · national
Continuity (1)
Related Publication 20230364164A1 · Nov 16, 2023
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