Clinical trial · Interventional
"Lactobacillus Crispatus M247, LSIL and Microbiota"
Interventional Study on Efficacy of Lactobacillus Crispatus M247 in Patients Affected by HPV Low-grade Preneoplastic Cervical Lesions and Evaluation of Vaginal Microbiota Changes Before and After Oral Supplementation
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
Patients affected by ASC-US/ low-grade HPV cervical lesions will be randomly assigned to treatment arm vs control arm. The treatment arm will include the characterization of the vaginal microbiota at enrollment (T0), 4 months of oral treatment with Lactobacillus Crispatus M 247 (1 buccal stick Die), characterization of the vaginal microbiota at 1 month post treatment (T5 m). The vaginal microbiota will be evaluated by Danagene microbiome vaginal DNA KIT-XMICROGem (XBIOGem) test, with amplification of the variable regions of the 16S ribosomal RNA gene, using the MICROBIOTA kit (CE-IVD - ARROW diagnostics) and second generation sequencing technologies (NGS on Illumina MiSeq platform). The control arm will provide for the characterization of the vaginal microbiota at the same timescales. Patients will be given a medical history questionnaire at T0 and T5m
Conditions
Conditions (4)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| ASC-US | — | UNRESOLVED | — |
| HPV Infection | — | UNRESOLVED | — |
| LSIL | Low Grade Squamous Intraepithelial Neoplasia | ALIAS | 0.90 |
| Vaginal Flora Imbalance | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Lactobacillus Crispatus M247 | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Arm A
- description
- Patient with oral supplementation of Lactobacillus Crispatus M247
- interventionNames
- Drug: Lactobacillus Crispatus M247
- type
- NO_INTERVENTION
- label
- Arm B
- description
- Patients without oral supplementation of Lactobacillus Crispatus M247
Primary outcomes (1)
- measure
- To evaluate the efficacy of Lactobacillus Crispatus M247 oral supplementation to change the genetic profile of the vaginal microbiota of patients with low-grade lesions from HPV, by XBIOGem test.
- timeFrame
- 5 months
Secondary outcomes (3)
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Pap smear ASCUS or L-SIL * HPV test + (HPV-HR e/o HPV-LR) Exclusion Criteria: * Hormonal therapy (OC, ring, patch, implant) * Pregnancy status * Immunosuppressive therapies * Ongoing HPV vaccination
References
Publications (0)
Data not yet available