Evidence map›Paper›PMID 41566207›Full record

Trial reportBMC microbiology2026

Postbiotics originated from Lactobacillus crispatus NCU-31 improves vulvar lichen sclerosus: a randomized, double-blind controlled trial.

Hong Liao, Qifa Huang, Xue Wu, Leiping Ding, Ying Jiang, Fen Wei, Xiaoyan Ai, Hailian Luo, Qi Chen, Tingtao Chen

Abstract readRandomized Controlled Trial
In one paragraph

Trial report in BMC microbiology, 2026. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 1 paper.

0numbers the graph read from it
0cells of the map it votes in
1citing papers in PubMed
–field-weighted citation impact
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.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

1 citing paper in PubMed.

  1. Review
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

10 authors.

Hong Liao *Department of Obstetrics and Gynecology, The Second Affiliated Hospital, Jiangxi Medical College, Nanchang University, 1 Minde Road, Donghu District, Nanchang City, 330000, Jiangxi Province, China.
Qifa Huang *Department of Obstetrics and Gynecology, The Second Affiliated Hospital, Jiangxi Medical College, Nanchang University, 1 Minde Road, Donghu District, Nanchang City, 330000, Jiangxi Province, China.
Xue WuDepartment of Obstetrics and Gynecology, The Second Affiliated Hospital, Jiangxi Medical College, Nanchang University, 1 Minde Road, Donghu District, Nanchang City, 330000, Jiangxi Province, China.
Leiping DingJiangxi Province Key Laboratory of Bioengineering Drugs, School of Pharmacy, Jiangxi Medical College, Nanchang University, Nanchang, 330031, China.
Ying JiangDepartment of Obstetrics and Gynecology, The Second Affiliated Hospital, Jiangxi Medical College, Nanchang University, 1 Minde Road, Donghu District, Nanchang City, 330000, Jiangxi Province, China.
Fen WeiDepartment of Obstetrics and Gynecology, The Second Affiliated Hospital, Jiangxi Medical College, Nanchang University, 1 Minde Road, Donghu District, Nanchang City, 330000, Jiangxi Province, China.
Xiaoyan AiGynecology Department, Jiangxi Maternal and Child Health Hospital, Maternal and Child Health Hospital of Nanchang Medical College, Nanchang, China.
Hailian LuoPathology Department, Nanchang Medical College, Jiangxi Maternal and Child Health Hospital , Nanchang, China.
Qi ChenDepartment of Obstetrics and Gynecology, The Second Affiliated Hospital, Jiangxi Medical College, Nanchang University, 1 Minde Road, Donghu District, Nanchang City, 330000, Jiangxi Province, China. chenqiyangbai@126.com.
Tingtao ChenJiangxi Province Key Laboratory of Bioengineering Drugs, School of Pharmacy, Jiangxi Medical College, Nanchang University, Nanchang, 330031, China. chentingtao1984@163.com.

Funding

Jiangxi Province Key Laboratory of bioengineering drugs 2024SSY07061Jiangxi Provincial Health Commission's General Science and Technology Plan No.202310937the National Natural Science Foundation of China 82460297 and 82260389the National Natural Science Foundation of China 82460528 and 82260507
6 · The paper itself

Abstract

backgroundVulvar lichen sclerosus (VLS) is a chronic inflammatory skin disorder that severely impairs women’s physical and psychological well-being. Topical glucocorticoids are the first-line treatment; however, their long-term efficacy is limited due to frequent symptom relapse after discontinuation and incomplete resolution of lesions. Therefore, effective adjunctive strategies are urgently needed to achieve sustained disease control.

methodsThis study aimed to first characterize disease-associated alterations in vulvar skin microbiota by comparing patients with VLS and healthy volunteers using 16S rRNA gene sequencing. Based on these findings, we further evaluated the clinical efficacy of a postbiotic derived from Lactobacillus crispatus NCU-31 and its modulatory effects on vulvar skin microbiota in patients with VLS. Clinical efficacy was assessed using the Cattaneo Clinical Score and Investigator’s Global Assessment (IGA), Dermatology Life Quality Index (DLQI), and Vulvar Quality of Life Index (VQLI).

resultsCompared with healthy volunteers, VLS patients exhibited significantly increased microbial richness and diversity, characterized by a reduced relative abundance of Lactobacillus and elevated levels of Prevotella, Gardnerella, Dialister, and Streptococcus (p < 0.05). Compared with the placebo group, patients receiving combined postbiotic and glucocorticoid treatment showed significant clinical improvement, including lower IGA scores (0.38 ± 0.49 vs. 1.38 ± 0.49), improved DLQI (0.16 ± 0.37 vs. 3.86 ± 1.01), and improved VQLI (0.74 ± 0.66 vs. 6.36 ± 1.14) (p < 0.05). In addition, microbial dysbiosis was partially reversed in the postbiotic group, whereas no comparable microbiota normalization was observed in the placebo group.

conclusionsThis two-phase study first included an exploratory comparison of vulvar skin microbiota between patients with VLS and healthy controls, which provided biological context for the subsequent clinical investigation. Building on these findings, we demonstrated that the addition of L. crispatus NCU-31–derived postbiotics to standard glucocorticoid therapy significantly improved clinical outcomes and partially restored microbial homeostasis in patients with VLS. These results support the potential of postbiotic-based, microbiota-targeted adjunctive strategies for the management of VLS.

trial registrationhttp://www.chictr.org.cn/ , identifier (ChiCTR2400090750), registration time: 12/10/2024.

Indexed as

Lactobacillus crispatusProbioticsVulvar Lichen SclerosusAdultBacteriaDouble-Blind MethodFemaleHumansMiddle AgedQuality of LifeRNA, Ribosomal, 16SSkin MicrobiomeTreatment OutcomeRNA, Ribosomal, 16S16S rRNA gene sequencingLactobacillus crispatus NCU-31PostbioticVulvar lichen sclerosus

Identifiers

PMID41566207
PMCPMC12952109

What OpenQuestion holds

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LicenceCC BY-NC-ND
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Registered trials

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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 OpenQuestion graph.