Materials and methods for improving immune responses and skin and/or mucosal barrier functions
Inventors
Berkes, Eva A. • Monsul, Nicholas T. • BOEHM, Frederick T.
Assignees
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Publication Number
US-12440521-B2
Publication Date
2025-10-14
Expiration Date
Abstract
The subject invention provides compositions and methods for treating human dermatological conditions by employing a microbiome-centered treatment approach. Preferred embodiments of the invention provide pharmaceutical and cosmetic compositions, and the methods of using the same, comprising a strain of Lactobacillus fermentum bacterium, or bioactive extracts thereof, derived from human microbiota and capable of growing in biofilm phenotype.
Core Innovation
The invention relates to a composition comprising an isolated Lactobacillus fermentum bacterial strain grown as biofilm, and/or comprising a bioactive extract of said biofilm. The bacterial strain is Lactobacillus fermentum Qi6 having Accession No. PTA-122195, and the biological activity of the bioactive extract is selected from antimicrobial activity, promoting commensal bacterial growth, enhancing skin or mucous membrane barrier function, and enhancing a skin innate immune function.
The described activity profile emphasizes inhibiting pathogenic biofilm-associated effects while supporting commensal growth. The composition is stated to inhibit pathogenic, notably MRSA, biofilm growth and adhesion and to promote detachment, while promoting commensal bacterial growth, including Staphylococcus epidermidis.
The invention further states that Lf Qi6 biofilm bioactives enhance skin barrier function and enhance skin innate immune function. The document reports upregulation of barrier proteins and modulation of innate immune peptides and inflammatory cytokines, including beta defensins, and links the bioactives to PPAR activation, including PPAR-beta/gamma.
The document describes compositions intended for therapeutic and cosmetic use, including pharmaceutically acceptable excipients and cosmetically acceptable excipients. It reports biological findings across in vitro, ex vivo organotypic human skin, and co-culture models, and provides example formulation and product types for dermatological use.
Claims Coverage
The independent claim covers one composition centered on Lactobacillus fermentum Qi6 (PTA-122195) produced as a biofilm and/or a bioactive extract of that biofilm, with biological activity selected from antimicrobial activity, promoting commensal bacterial growth, enhancing skin or mucous membrane barrier function, and enhancing a skin innate immune function. Dependent claims refine the composition components and the context of use, including method endpoints for mucous membranes and an inactivation option.
Biofilm-grown Lactobacillus fermentum Qi6 composition
A composition comprising an isolated Lactobacillus fermentum bacterial strain grown as biofilm, and/or comprising a bioactive extract of said biofilm, wherein the bacterial strain is Lactobacillus fermentum Qi6 having Accession No. PTA-122195.
Bioactive extract selected biological activity
A composition wherein the biological activity of the bioactive extract is selected from antimicrobial activity, promoting commensal bacterial growth, enhancing skin or mucous membrane barrier function, and enhancing a skin innate immune function.
Bioactive extract derived composition
A composition provided in which the active material is a bioactive extract derived from the L. fermentum biofilm.
Pharmaceutically acceptable carrier
A pharmaceutical composition further including a pharmaceutically acceptable carrier.
Topical formulation product types
A topical formulation selected from lotion, cream, emulsion, ointment, oil, or gel.
Mucous membrane barrier function improvement by administration
Improving the barrier function and/or condition of a subject’s mucous membrane by administering an effective amount of the composition to the mucous membrane.
Inactivated Lactobacillus fermentum Qi6
A method further including inactivating Lactobacillus fermentum Qi6 having Accession No. PTA-122195.
Across the independent claim and refinements, the coverage focuses on Lactobacillus fermentum Qi6 (PTA-122195) as a biofilm and/or its bioactive extract, with activity selected to include antimicrobial effects, selective promotion of commensal growth, and enhancement of skin or mucous membrane barrier function and skin innate immune function. Dependent claims further specify component inclusion, topical product forms, mucous membrane barrier/condition improvement by administration of an effective amount, and an option to inactivate the Qi6 strain.
Stated Advantages
Inhibiting pathogenic biofilm growth and adhesion while promoting detachment.
Promoting commensal bacterial growth.
Enhancing skin or mucous membrane barrier function.
Enhancing a skin innate immune function.
Documented Applications
Human dermatological disorders, with topical compositions including lotions, creams, serums, face washes and related product types.
Possible use beyond dermatology, including mucosal barrier repair.
Certain viral infection contexts, including Epstein-Barr virus and cytomegalovirus.
Eosinophilic gastrointestinal disease, including an example oral gel formulation concept.
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