Evidence map›Paper›PMID 41258468›Full record

ArticleCommunications medicine2025

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

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

Registry-linked trialAbstract read
In one paragraph

Article in Communications medicine, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT06165354 (Evaluating the Effectiveness in Supportive Treatment of Vaginitis of Vaginal-spraying Bacillus Probiotic Spore Suspension), which is not on this map. Not yet cited in PubMed.

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0cells of the map it votes in
0citing papers in PubMed
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1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

NCT06165354 nacompletednot on this map

Evaluating the Effectiveness in Supportive Treatment of Vaginitis of Vaginal-spraying Bacillus Probiotic Spore Suspension (LiveSpo X-Secret)

TypeinterventionalSponsorAnabio R&DRan2023 to 2025Enrolled120ConditionsVaginitisArms0.9% NaCl physiological saline, LiveSpo X-secret
3 · Its place in the literature

Who cites it

0 citing papers in PubMed.

No citing paper in PubMed yet.

4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

9 authors.

Huyen Thi BuiSpobiotic Research Center, ANABIO R&D Ltd. Company, Ha Dong, Hanoi, Vietnam.ORCID http://orcid.org/0000-0001-6714-068X
Anh Thi Phuong BuiSpobiotic Research Center, ANABIO R&D Ltd. Company, Ha Dong, Hanoi, Vietnam.
Hong Thi NgoBac Ninh Center for Disease Control and Prevention, Nguyen Quyen, Vo Cuong, Bac Ninh, Vietnam.
Xuan Thi NgoBac Ninh Center for Disease Control and Prevention, Nguyen Quyen, Vo Cuong, Bac Ninh, Vietnam.
Huyen Thi NguyenLiveSpo Pharma Ltd. Company, N03T5, Ngoai Giao Doan Urban, Xuan Dinh, Hanoi, Vietnam.
Anh Hoa NguyenSpobiotic Research Center, ANABIO R&D Ltd. Company, Ha Dong, Hanoi, Vietnam. nguyenhoaanhbio@gmail.com.
Van Cam TranNational Hospital of Dermatology and Venereology, Kim Liên, Hanoi, Vietnam.
Tung Dinh PhamFaculty of Mathematics - Mechanics - Informatics, VNU University of Science, Vietnam National University_Hanoi, Thanh Xuan, Hanoi, Vietnam.
Anh Thi Van NguyenSpobiotic Research Center, ANABIO R&D Ltd. Company, Ha Dong, Hanoi, Vietnam. vananhbiolab@gmail.com.ORCID http://orcid.org/0000-0003-1215-6910

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundBacterial 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.

methodsWe 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.

resultsHere 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).

conclusionsThe 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.

Identifiers

PMID41258468
PMCPMC12717237

What Socratic holds

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Registered trials

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the Socratic graph.