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
试验速览
- 阶段
- 4 期
- 状态
- 招募中
- 入组人数
- 90
- 试验地点
- 1
- 主要终点
- 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.
研究概览
简要总结
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
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Pap smear ASCUS or L-SIL
- •HPV test + (HPV-HR e/o HPV-LR)
排除标准
- •Hormonal therapy (OC, ring, patch, implant)
- •Pregnancy status
- •Immunosuppressive therapies
- •Ongoing HPV vaccination
研究组 & 干预措施
Arm A
Patient with oral supplementation of Lactobacillus Crispatus M247
干预措施: Lactobacillus Crispatus M247 (Drug)
结局指标
主要结局
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.
时间窗: 5 months
次要结局
- Evaluate the applicability in clinical practice of the XBIOGem test in the characterization of the vaginal microbiota in this type of patient(24 months)
- Evaluation of the role of anamnestic factors on the characterization of vaginal microbiota(24 months)
- Cytological regression and microbiological clearance of HPV infection(5 months)