Patent Application Number:

202410239290.9

Applicants:

Wecare Probiotics Co., Ltd.

Inventors:

Fang Shuguang, Dong Yao, Qi Yongmei, Qian Limin

Filed Date:

March 4, 2024

Publication Date:

April 9, 2024

Abstract:

This invention relates to a probiotic preparation designed to regulate brain-derived neurotrophic factor (BDNF) and sex hormones. The preparation includes strains of Bifidobacterium longum subsp. longum BL21 (CGMCC No. 10452) and Lactobacillus crispatus LCr86 (CGMCC No. 19758). This novel combination of probiotics exhibits potential synergistic effects in regulating BDNF and sex hormones, particularly in the treatment of polycystic ovary syndrome (PCOS).

Technical Field:

The invention belongs to the field of biotechnology and pharmaceutical preparations, specifically concerning a probiotic composition for modulating neurotrophic factors and sex hormones to treat conditions like PCOS.

Background:

BDNF is a key molecule that interacts with TrkB receptors to activate downstream signaling pathways. In the context of PCOS, the role of BDNF and its receptors is not well understood, but their expression in non-neuronal tissues like ovaries is associated with oocyte maturation. Probiotic interventions can enhance BDNF expression, potentially offering new diagnostic and therapeutic options for infertility and ovarian pathologies.

Summary of Invention:

The primary objective is to develop a probiotic agent that can modulate BDNF and sex hormones to improve ovarian function and manage PCOS. The probiotic agent comprises Bifidobacterium longum subsp. longum BL21 and Lactobacillus crispatus LCr86. These strains, when combined, show a synergistic effect in improving ovarian dysfunction, regulating BDNF signaling, enhancing hormone and metabolic levels, and improving gut microbiota diversity compared to using each strain individually.

Detailed Description:

1. Probiotic Strains:

   - Bifidobacterium longum subsp. longum BL21 (CGMCC No. 10452)

   - Lactobacillus crispatus LCr86 (CGMCC No. 19758)

2. Combination and Synergy:

   - The combination of BL21 and LCr86 shows enhanced efficacy in modulating BDNF and sex hormones.

   - Significant improvements in ovarian function, hormone regulation, metabolic levels, and gut microbiota diversity are observed with the combined use of these strains.

3. Applications:

   - The probiotic composition is intended for use in preventing, improving, or treating PCOS.

   - The formulation can be delivered in various forms, including freeze-dried powder, capsules, tablets, or granules.

4. Dosage and Administration:

   - The ratio of active bacterial strains in the probiotic composition ranges from 1:10 to 10:1.

   - The total viable bacterial count is not less than 2×10^9 CFU/mL or 2×10^9 CFU/g.

5. Additional Ingredients:

   - Freeze-drying protectants and auxiliary additives such as inulin, oligosaccharides, soy oligosaccharides, and others may be included to enhance stability and efficacy.

Claims:

1. The probiotic composition for regulating BDNF and sex hormones.

2. The specific ratio of Bifidobacterium longum subsp. longum BL21 to Lactobacillus crispatus LCr86.

3. The inclusion of freeze-drying protectants and auxiliary additives for enhanced stability.

Advantages:

- Offers a novel strategy for managing PCOS.

- Enhances the safety and efficacy of probiotic-based treatments.

- Provides a high safety profile with low risk of dependency due to the use of probiotics.

This patent represents a significant advancement in the field of probiotic therapies aimed at managing PCOS by leveraging the synergistic effects of specific probiotic strains to regulate critical neurotrophic and hormonal pathways.