Title:
NEONATAL MICROBIOME SUPPLEMENTATION
Document Type and Number:
WIPO Patent Application WO/2015/177246
Kind Code:
A3
Abstract:
The present invention aims to prevent and/or treat health-related conditions in infants born with a non-optimal intestinal microbiome, by providing specific probiotic lactic acid bacterial strains to the pregnant mother. This will enable early colonization of the infant gut, even before birth, and thus prevent and/or treat health-related conditions associated with non- optimal microbiome. Thus, the present invention provides a probiotic microorganism for use in the treatment of a fetus or neonate, wherein said probiotic microorganism is administered to the oral cavity of a pregnant female in a formulation suitable to colonize the oral cavity, wherein said probiotic microorganism is thereby administered to the fetus. The methods and uses of the invention can also provide for the colonization of a fetus or neonate or for shifting the microbiome of a fetus or neonate.
Inventors:
MÖLLSTAM BO (SE)
AAGAARD KJERSTI (US)
AAGAARD KJERSTI (US)
Application Number:
PCT/EP2015/061181
Publication Date:
March 03, 2016
Filing Date:
May 20, 2015
Export Citation:
Assignee:
BIOGAIA AB (SE)
International Classes:
A61K35/747; A61K35/745; A61P1/00; A61P1/02; A61P1/06; A61P13/00; A61P31/00
Other References:
HANIA SZAJEWSKA ET AL: "Lactobacillus reuteri DSM 17938 for the Management of Infantile Colic in Breastfed Infants: A Randomized, Double-Blind, Placebo-Controlled Trial", THE JOURNAL OF PEDIATRICS, vol. 162, no. 2, 1 February 2013 (2013-02-01), pages 257 - 262, XP055119452, ISSN: 0022-3476, DOI: 10.1016/j.jpeds.2012.08.004
F. SAVINO ET AL: "Lactobacillus reuteri DSM 17938 in Infantile Colic: A Randomized, Double-Blind, Placebo-Controlled Trial", PEDIATRICS, vol. 126, no. 3, 16 August 2010 (2010-08-16), pages e526 - e533, XP055119050, ISSN: 0031-4005, DOI: 10.1542/peds.2010-0433
FLAVIA INDRIO MD ET AL: "Prophylactic Use of a Probiotic in the Prevention of Colic, Regurgitation, and Functional Constipation: A Randomized Clinical Trial", JAMA PEDIATRICS, AMERICAN MEDICAL ASSOCIATION, USA, vol. 168, no. 3, 1 March 2014 (2014-03-01), pages 228 - 233, XP009185438, ISSN: 2168-6203, DOI: 10.1001/JAMAPEDIATRICS.2013.4367
N. ELAZAB ET AL: "Probiotic Administration in Early Life, Atopy, and Asthma: A Meta-analysis of Clinical Trials", PEDIATRICS, vol. 132, no. 3, 19 August 2013 (2013-08-19), pages e666 - e676, XP055185032, ISSN: 0031-4005, DOI: 10.1542/peds.2013-0246
RAUTAVA S ET AL: "Probiotics modulate host-microbe interaction in the placenta and fetal gut: a randomized, double-blind, placebo-controlled trial", NEONATOLOGY, vol. 102, no. 3, 6 July 2012 (2012-07-06), pages 178 - 184, XP009185442, ISSN: 1661-7800, [retrieved on 20120706]
R. N. FICHOROVA ET AL: "Maternal Microbe-Specific Modulation of Inflammatory Response in Extremely Low-Gestational-Age Newborns", MBIO, vol. 2, no. 1, art. n° e00280-10, 18 January 2011 (2011-01-18), pages 1 - 8, XP055204097, DOI: 10.1128/mBio.00280-10
DATABASE PubMed [online] May 2012 (2012-05-01), KELLER ET AL: "Effect of chewing gums containing the probiotic bacterium Lactobacillus reuteri on oral malodour.", XP002743831, retrieved from NCBI Database accession no. 22182258
PROF. DR. ULRICH SCHLAGENHAUF: "Probiotics and plaque control in pregnant women", 8 June 2012 (2012-06-08), XP054976042, Retrieved from the Internet [retrieved on 20150902]
JACKIE ELIAS ET AL: "Are probiotics safe for use duringpregnancy and lactation?", MOTHERISK-CANADIAN FAMILY PHYSICIAN - LE MÉDECIN DE FAMILLE CANADIEN, vol. 57, 1 March 2011 (2011-03-01), pages 299 - 301, XP055203126, Retrieved from the Internet [retrieved on 20150717]
ANNA HAUKIOJA ET AL: "Probiotics and Oral Health", EUROPEAN JOURNAL OF DENTISTRY, vol. 4, 1 July 2010 (2010-07-01), pages 348 - 355, XP055205540, Retrieved from the Internet [retrieved on 20150730]
CAROLINE RODUIT ET AL: "Prenatal animal contact and gene expression of innate immunity receptors at birth are associated with atopic dermatitis", JOURNAL OF ALLERGY AND CLINICAL IMMUNOLOGY, ELSEVIER, AMSTERDAM, NL, vol. 127, no. 1, 7 October 2010 (2010-10-07), pages 179 - 185.e1, XP028150403, ISSN: 0091-6749, [retrieved on 20101019], DOI: 10.1016/J.JACI.2010.10.010
MARGARITA INIESTA ET AL: "Probiotic effects of orally administered Lactobacillus reuteri -containing tablets on the subgingival and salivary microbiota in patients with gingivitis. A randomized clinical trial", JOURNAL OF CLINICAL PERIODONTOLOGY, vol. 39, no. 8, 1 August 2012 (2012-08-01), pages 736 - 744, XP055203122, ISSN: 0303-6979, DOI: 10.1111/j.1600-051X.2012.01914.x
M.R. VIVEKANANDA ET AL: "A probiotic lozenge administered medical device and its effect on salivary mutans streptococci and lactobacilli", JOURNAL OF ORAL MICROBIOLOGY, vol. 18, no. 0, 2 November 2010 (2010-11-02), pages 35, XP055203112, DOI: 10.1099/mic.0.035642-0
M. STENSSON ET AL.: "Oral Administration of Lactobacillus reuteri duringthe First Year of Life Reduces Caries Prevalence inthe Primary Dentition at 9 Years of Age", EUROPEAN JOURNAL OF DENTISTRY, 29 November 2013 (2013-11-29), pages 111 - 117, XP002743832
F. SAVINO ET AL: "Lactobacillus reuteri DSM 17938 in Infantile Colic: A Randomized, Double-Blind, Placebo-Controlled Trial", PEDIATRICS, vol. 126, no. 3, 16 August 2010 (2010-08-16), pages e526 - e533, XP055119050, ISSN: 0031-4005, DOI: 10.1542/peds.2010-0433
FLAVIA INDRIO MD ET AL: "Prophylactic Use of a Probiotic in the Prevention of Colic, Regurgitation, and Functional Constipation: A Randomized Clinical Trial", JAMA PEDIATRICS, AMERICAN MEDICAL ASSOCIATION, USA, vol. 168, no. 3, 1 March 2014 (2014-03-01), pages 228 - 233, XP009185438, ISSN: 2168-6203, DOI: 10.1001/JAMAPEDIATRICS.2013.4367
N. ELAZAB ET AL: "Probiotic Administration in Early Life, Atopy, and Asthma: A Meta-analysis of Clinical Trials", PEDIATRICS, vol. 132, no. 3, 19 August 2013 (2013-08-19), pages e666 - e676, XP055185032, ISSN: 0031-4005, DOI: 10.1542/peds.2013-0246
RAUTAVA S ET AL: "Probiotics modulate host-microbe interaction in the placenta and fetal gut: a randomized, double-blind, placebo-controlled trial", NEONATOLOGY, vol. 102, no. 3, 6 July 2012 (2012-07-06), pages 178 - 184, XP009185442, ISSN: 1661-7800, [retrieved on 20120706]
R. N. FICHOROVA ET AL: "Maternal Microbe-Specific Modulation of Inflammatory Response in Extremely Low-Gestational-Age Newborns", MBIO, vol. 2, no. 1, art. n° e00280-10, 18 January 2011 (2011-01-18), pages 1 - 8, XP055204097, DOI: 10.1128/mBio.00280-10
DATABASE PubMed [online] May 2012 (2012-05-01), KELLER ET AL: "Effect of chewing gums containing the probiotic bacterium Lactobacillus reuteri on oral malodour.", XP002743831, retrieved from NCBI Database accession no. 22182258
PROF. DR. ULRICH SCHLAGENHAUF: "Probiotics and plaque control in pregnant women", 8 June 2012 (2012-06-08), XP054976042, Retrieved from the Internet
JACKIE ELIAS ET AL: "Are probiotics safe for use duringpregnancy and lactation?", MOTHERISK-CANADIAN FAMILY PHYSICIAN - LE MÉDECIN DE FAMILLE CANADIEN, vol. 57, 1 March 2011 (2011-03-01), pages 299 - 301, XP055203126, Retrieved from the Internet
ANNA HAUKIOJA ET AL: "Probiotics and Oral Health", EUROPEAN JOURNAL OF DENTISTRY, vol. 4, 1 July 2010 (2010-07-01), pages 348 - 355, XP055205540, Retrieved from the Internet
CAROLINE RODUIT ET AL: "Prenatal animal contact and gene expression of innate immunity receptors at birth are associated with atopic dermatitis", JOURNAL OF ALLERGY AND CLINICAL IMMUNOLOGY, ELSEVIER, AMSTERDAM, NL, vol. 127, no. 1, 7 October 2010 (2010-10-07), pages 179 - 185.e1, XP028150403, ISSN: 0091-6749, [retrieved on 20101019], DOI: 10.1016/J.JACI.2010.10.010
MARGARITA INIESTA ET AL: "Probiotic effects of orally administered Lactobacillus reuteri -containing tablets on the subgingival and salivary microbiota in patients with gingivitis. A randomized clinical trial", JOURNAL OF CLINICAL PERIODONTOLOGY, vol. 39, no. 8, 1 August 2012 (2012-08-01), pages 736 - 744, XP055203122, ISSN: 0303-6979, DOI: 10.1111/j.1600-051X.2012.01914.x
M.R. VIVEKANANDA ET AL: "A probiotic lozenge administered medical device and its effect on salivary mutans streptococci and lactobacilli", JOURNAL OF ORAL MICROBIOLOGY, vol. 18, no. 0, 2 November 2010 (2010-11-02), pages 35, XP055203112, DOI: 10.1099/mic.0.035642-0
M. STENSSON ET AL.: "Oral Administration of Lactobacillus reuteri duringthe First Year of Life Reduces Caries Prevalence inthe Primary Dentition at 9 Years of Age", EUROPEAN JOURNAL OF DENTISTRY, 29 November 2013 (2013-11-29), pages 111 - 117, XP002743832
Attorney, Agent or Firm:
OWEN, Deborah (10 Salisbury Square, London EC4Y 8JD, GB)
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