Effect of Honey for CIN II
- Conditions
- Cervical Intraepithelial Neoplasia-IIHigh Risk Human Papillomavirus
- Interventions
- Other: Medical grade honey formulation (MGH) (L-Mesitran®)
- Registration Number
- NCT06219018
- Lead Sponsor
- Zuyderland Medisch Centrum
- Brief Summary
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.
- Detailed Description
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 assesses the potential effect of honey and provides insight into its mechanisms of action.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- Female
- Target Recruitment
- 60
- Women 18-40 years
- Primary CIN II confirmed histologically in the biopsy on colposcopic examination
- Sufficient mastery of the Dutch language
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Medical grade honey formulation (MGH) (L-Mesitran®) for CIN II group 2 Medical grade honey formulation (MGH) (L-Mesitran®) Group 2, pt 20-40: daily application of 5 grams (with applicator) for 3 months. Then weekly applications (5 grams with applicator) for3 months. Medical grade honey formulation (MGH) (L-Mesitran®) for CIN II group 1 Medical grade honey formulation (MGH) (L-Mesitran®) Group 1, pt 0-20: daily application of 5 grams (with applicator) for 1 month. Followed by weekly applications (5 grams withapplicator) for 5 months. Medical grade honey formulation (MGH) (L-Mesitran®) for CIN II group 3 Medical grade honey formulation (MGH) (L-Mesitran®) Group 3, pt 40-60: daily application of 5 grams (with applicator) for 6 months Medical grade honey formulation (MGH) (L-Mesitran®) for CIN II Medical grade honey formulation (MGH) (L-Mesitran®) Daily application of 5 grams (with applicator) for 3 months. Then weekly application (5 grams with applicator) for 3 months.
- Primary Outcome Measures
Name Time Method Clearance of hr-HPV 6 months The following hypothesis is tested: Medical grade honey in CIN II causes a higher clearance of the hr-HPV virus
- Secondary Outcome Measures
Name Time Method Regression of CIN II 12-24 months Defined as a regression to Pap1
Clearance of hr-HPV and normalization of cytology (KOPAC) 12-24 mnths Normalization of cytology (KOPAC) (depending on NVOG/RIVM flowchart).
Characteristics of the vaginal microbiome 0-6 months Species specific and diversity analysis, changes due to honey and relationship with the other outcomes measures
Trial Locations
- Locations (2)
Zuyderland MC
🇳🇱Heerlen, Limburg, Netherlands
Maastricht University Medical Centre+
🇳🇱Maastricht, Limburg, Netherlands