Vaginal-spray Bacillus spore probiotics as a potential treatment and reducing recurrence of bacterial vaginosis: randomized, double-blind, and controlled pilot study
Bibliographic record
Abstract
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.
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How this classification was reachedexpand
Full frame distilled prediction
Teacher imitationNot calibrated prevalence, not ground truth. Human validation pending. Learned from the 10,348 direct Codex labels and 10,348 direct Gemma labels. Candidate is the union of thresholded teacher heads; consensus is their intersection. These outputs are machine_predicted_unvalidated and are not human labels or direct frontier model labels.
Codex and Gemma teacher scores by category
| Category | Codex | Gemma |
|---|---|---|
| Metaresearch | 0.002 | 0.001 |
| Meta-epidemiology (narrow) | 0.000 | 0.000 |
| Meta-epidemiology (broad) | 0.001 | 0.000 |
| Bibliometrics | 0.000 | 0.000 |
| Science and technology studies | 0.000 | 0.002 |
| Scholarly communication | 0.000 | 0.000 |
| Open science | 0.000 | 0.000 |
| Research integrity | 0.000 | 0.000 |
| Insufficient payload (model declined to judge) | 0.000 | 0.000 |
Machine scores (provisional)
The two teacher heads of the student model, read on this work. A score orders the frame for review; it never asserts a category, and the validation status ships verbatim with every row.
Baseline scores from an immature model (maturity gate not passed, 7 training rounds). Scores rank; they never assert a category.
score_only:v0-immature-baseline · verbatim from the scoring run: score_only means the number may rank works, and no category label ships from itClassification
machine, unvalidatedMachine predicted; a candidate call from one teacher head, not a consensus.
How this classification was reached, model by model and score by score, is at the end of the page under "How this classification was reached".