Study on the Efficacy of Crispact® (Probiotic Containing Lactobacillus Crispatus M247) in the Sterilization of HPV-HR and in the Reconstitution of the Normal Vaginal Microbiota
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 150
- 主要终点
- Changes in vaginal bacterial quantity (population) that colonize, called Community State Type (CST)
研究概览
简要总结
There is growing scientific interest in probiotic supplementation as a possible therapy for clearing the human papillomavirus (HPV) infection and reducing the risk of developement of cervical cancer.
详细描述
This is a multicenter, randomized, longitudinal, prospective, parallel-group, single-blind study aimed to investigate the efficacy of probiotic Crispact® (which contains: 20 Bld CFU/Stick of Lactobacillus crispatus M247) in clearance of human papillomavirus (HPV) infection in healthy female who tested positive for human papillomavirus (HPV) infection.
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
- Single (Investigator)
入排标准
- 年龄范围
- 18 Years 至 64 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Women able to understand and agree to participation in the study and be able to provide written informed consent to the trial.
- •Women aged 25-29 years who perform screening pap smears with the result: Low- grade squamous intraepithelial lesion (LSIL) or Atypical Squamous Cells of Undetermined Significanc (ASCUS) (for which, as per the recommendation of the Italian Society of Colposcopy and Cervico-Vaginal Pathology (SICPCV)/Italian Group of Cervical Cancer. Screening (GISCI), no treatment is indicated but only follow-up with Human papillomavirus (HPV) test at 12 months.
- •Women aged 18-64 who independently perform a positive High risk sub-types of HPV (HR-HPV) test outside of screening even in the presence of a negative cytology (for whom, as per the recommendation of the SICPCV, no treatment is indicated but only follow-up with HPV test at 12 months).
- •Women aged 30-64 years HPV HR positive with negative cytology or with positive cytology for ASCUS or LSIL but negative colposcopy (absence of colposcopic lesion or positive colposcopy but subsequent negative biopsy) who do not require treatment (therefore as per the recommendation of the SICPCV go to follow-up with HPV testing at 12 months).
排除标准
- •Women who have been vaccinated for HPV.
- •Patients who have undergone cervical treatments for preneoplastic pathology.
- •Patients with High-Grade Squamous Intraepithelial Lesion (HSIL) cytological result who on histological examination after biopsy need treatment according to the SICPCV 2019 recommendations.
- •Hypersensitivity to one or more components of the product.
- •Patients being treated with antibiotic, immunomodulatory and immunosuppressive therapies.
- •Patients with immune system or neoplastic pathologies being treated with chemotherapy
- •Patients who are pregnant, breastfeeding, or planning to become pregnant in the next 6 months.
结局指标
主要结局
Changes in vaginal bacterial quantity (population) that colonize, called Community State Type (CST)
时间窗: After 4-months
Changes in vaginal microbiota
Human papillomavirus (HPV) clearance
时间窗: After 4-months
Testing negative for HPV
次要结局
未报告次要终点
研究者
Dr. Amjad Khan
Professor of Clinical Biochemistry and Experimental Medicine
Liaquat University of Medical & Health Sciences