The Effect of Medical Grade Honey (L-Mesitran) for Cervical Intraepithelial Neoplasia-II
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 发起方
- 入组人数
- 60
- 试验地点
- 2
- 主要终点
- Clearance of hr-HPV
研究概览
简要总结
The following hypothesis is tested: Medical grade honey in CIN II causes a higher clearance of the hr-HPV virus and an increase in the normalization of CIN II lesions compared to expectant management.
详细描述
In this pilot study, we will include 60 patients with newly diagnosed CIN II. Patients will be counseled according to standard guidelines between a LLETZ, imiquimod or expectant management. Patients choosing for expectant management will be asked to participate in the study and will be treated with medical grade honey. Patients choosing for expectant management but not participating in the study and thus not using medicinal honey will be asked for the control arm. Follow-up assessment takes place in accordance with the national guideline (first check-up is after 6 months). In addition, swabs for vaginal microbiota analysis will be taken at 0 and 6 months. Immunohistochemical stainings for the local immune infiltrate will be performed on biopsies taken during regular colposcopy at t=0. This exploratory study aims to investigate if there is a potential effect of honey and provides insight into its mechanisms of action.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 40 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Women 18-40 years
- •Primary CIN II confirmed histologically in the biopsy on colposcopic examination
- •Sufficient mastery of the Dutch language
排除标准
- •Simultaneous abnormality in columnar epithelial cells (AIS).
- •Hr-HPV negative cytology
- •Immunosuppressant use/Autoimmune disease (HIV, CVID)
- •History of cervical carcinoma or previous treatment for CIN (LLETZ or imiquimod)
- •Pregnancy or the intention to become pregnant during the study period
- •Legal incompetence
- •Known allergies to honey
研究组 & 干预措施
Medical grade honey formulation (MGH) (L-Mesitran®) for CIN II
Daily application of 5 grams (with applicator) for 3 months. Then weekly application (5 grams with applicator) for 3 months.
干预措施: Medical grade honey formulation (MGH) (L-Mesitran®) (Drug)
结局指标
主要结局
Clearance of hr-HPV
时间窗: 6 months
The following hypothesis is tested: Medical grade honey in CIN II causes a higher clearance of the hr-HPV virus
次要结局
- Clearance of hr-HPV and normalization of cytology (KOPAC)(12-24 months)
- Regression of CIN II(12-24 months)
- Characteristics of the vaginal microbiome(0-6 months)
- Cervical immune status(0 months)
- Human vaginal gene expression profiles(0 and 6 months)
- Quality of life, side-effects and compliance with medical grade honey(0, 6, 12 and 24 months)