Effect of orally administered L. crispatus M247 in favoring HR-HPV clearance and CST shift: results from a randomized, multi-center, placebo-controlled trial.
- 2025-10-22
- Scientific reports 15(1)
- Francesco Di Pierro
- Emanuela Gloria Sampugnaro
- Giovanna Erika Lomeo
- Maria Francesca Guarneri
- Stefania Cusenza
- Alessia Pivetti
- Amjad Khan
- Fazle Rabbani
- Nazia Mumtaz Memon
- Massimiliano Cazzaniga
- Alexander Bertuccioli
- Mariarosaria Matera
- Ilaria Cavecchia
- Martino Recchia
- Chiara Maria Palazzi
- Maria Laura Tanda
- Nicola Zerbinati
- Emilio Lomeo
- PubMed: 41125728
- DOI: 10.1038/s41598-025-20838-5
Study Design
- Type
- Randomized Controlled Trial (RCT)
- Sample size
- n = 62
- Population
- 62 women newly diagnosed of HPV infection without visible cervical lesions at colposcopy
- Methods
- prospective, multi-center, randomized, placebo-controlled trial with oral treatment (daily, 4 months) of L. crispatus M247
- Blinding
- Double-blind
- Duration
- 4 months
- Funding
- Unclear
- Rigorous Journal
Epidemiological evidence support the idea that CST I, L. crispatus-dominated vaginal microbiota, could protect women form cervical HPV infection also favoring the HPV clearance. Our prospective, multi-center, randomized, placebo-controlled trial on 62 women newly diagnosed of HPV infection without visible cervical lesions at colposcopy, was mainly aimed at evaluating the role exerted by the oral treatment (daily, 4 months) with the strain L. crispatus M247 in prompting the HR-HPV clearance and CST shift. The results of our study demonstrated that the probiotic treatment significantly increased versus control: (i) the HPV clearance (60% versus 31.8%), and (ii) the number of negative PAP tests (83.3% versus 71.4%), favoring also the vaginal microbiota eubiosis. Particularly, the vaginal microbiota analysis demonstrated a significant relationship between the observed HPV clearance and: (i) a reduced richness; (ii) an increased relative presence of L. crispatus; and (iii) an increased number of women with a CST I microbiota. While a larger study would further strengthen these findings, the current evidence provides encouraging insights into the potential efficacy of the oral treatment with the strain L. crispatus M247.