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Background <p>Bacterial vaginosis (BV) is a common vaginal disorder characterized by reduced beneficial species and overgrowth of pathogens. Probiotics, especially direct vaginal sprays, offer a promising alternative to antibiotics by restoring healthy vaginal microbiota, relieving symptoms, and preventing recurrence.</p> Methods <p>We conducted a clinical trial (ClinicalTrials.gov: NCT06165354; 8/12/2023) to evaluate the effectiveness of the vaginal-spray probiotic LiveSpo X-Secret, containing <i>Bacillus subtilis</i>, <i>B. clausii</i>, and <i>B. coagulans</i> spores (≥1 billion CFU/mL). A total of 120 women were randomized equally into Control and X-Secret groups at Bac Ninh CDC. Outcomes were assessed at day 7 (end of standard treatment) for symptom resolution and day 28 (21 days post-treatment) for recurrence. Both Per-Protocol and Intention-to-Treat analyses were performed to assess efficacy and account for attrition.</p> Results <p>Here we show that no adverse events occur in either group. Compared to the Control, the X-Secret group exhibits a faster reduction in BV symptoms (odor, discharge, pH &gt;4.5, and itching) by days 7 and 28, with odds ratios at day 28 of 3.61, 4.87, 2.95, and 3.34, respectively. Vaginal swab analysis reveals a 3.7–225.3-fold greater reduction in <i>Gardnerella vaginalis</i>. By day 28, metagenomic profiling indicates increases in beneficial species <i>Lactobacillus crispatus</i> (3.71-fold) and <i>Streptococcus salivarius</i> (from non-detectable to 2.1%), along with reductions in harmful species <i>G. vaginalis</i> (14.29-fold) and <i>Sneathia sanguinegens</i> (806-fold).</p> Conclusions <p>The vaginal-spray <i>Bacillus</i> spore probiotic (LiveSpo X-Secret) provides a safe, convenient, and effective approach for BV treatment and reducing recurrence, supporting its potential as an adjunctive therapy for maintaining vaginal health.</p> Clinical trial number <p>ClinicalTrials.gov NCT06165354, first posted 8/12/2023.</p>

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Vaginal-spray Bacillus spore probiotics as a potential treatment and reducing recurrence of bacterial vaginosis: randomized, double-blind, and controlled pilot study

  • 期刊论文

  • 出版模式：

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  • 发表日期：

    2025年11月18日

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  • Huyen Thi Bui,
  • Anh Thi Phuong Bui,
  • Hong Thi Ngo,
  • Xuan Thi Ngo,
  • Huyen Thi Nguyen,
  • Anh Hoa Nguyen,
  • Van Cam Tran,
  • Tung Dinh Pham,
  • Anh Thi Van Nguyen

摘要

Background

Bacterial vaginosis (BV) is a common vaginal disorder characterized by reduced beneficial species and overgrowth of pathogens. Probiotics, especially direct vaginal sprays, offer a promising alternative to antibiotics by restoring healthy vaginal microbiota, relieving symptoms, and preventing recurrence.

Methods

We conducted a clinical trial (ClinicalTrials.gov: NCT06165354; 8/12/2023) to evaluate the effectiveness of the vaginal-spray probiotic LiveSpo X-Secret, containing Bacillus subtilis, B. clausii, and B. coagulans spores (≥1 billion CFU/mL). A total of 120 women were randomized equally into Control and X-Secret groups at Bac Ninh CDC. Outcomes were assessed at day 7 (end of standard treatment) for symptom resolution and day 28 (21 days post-treatment) for recurrence. Both Per-Protocol and Intention-to-Treat analyses were performed to assess efficacy and account for attrition.

Results

Here we show that no adverse events occur in either group. Compared to the Control, the X-Secret group exhibits a faster reduction in BV symptoms (odor, discharge, pH >4.5, and itching) by days 7 and 28, with odds ratios at day 28 of 3.61, 4.87, 2.95, and 3.34, respectively. Vaginal swab analysis reveals a 3.7–225.3-fold greater reduction in Gardnerella vaginalis. By day 28, metagenomic profiling indicates increases in beneficial species Lactobacillus crispatus (3.71-fold) and Streptococcus salivarius (from non-detectable to 2.1%), along with reductions in harmful species G. vaginalis (14.29-fold) and Sneathia sanguinegens (806-fold).

Conclusions

The vaginal-spray Bacillus spore probiotic (LiveSpo X-Secret) provides a safe, convenient, and effective approach for BV treatment and reducing recurrence, supporting its potential as an adjunctive therapy for maintaining vaginal health.

Clinical trial number

ClinicalTrials.gov NCT06165354, first posted 8/12/2023.