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.
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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
60
Daily application of 5 grams (with applicator) for the first 3 months, followed by weekly application of 5 grams for the following 3 months.
Zuyderland MC
Heerlen, Limburg, Netherlands
RECRUITINGMaastricht University Medical Centre+
Maastricht, Limburg, Netherlands
NOT_YET_RECRUITINGClearance of hr-HPV
The following hypothesis is tested: Medical grade honey in CIN II causes a higher clearance of the hr-HPV virus
Time frame: 6 months
Regression of CIN II
Defined as a regression to Pap 1
Time frame: 12-24 months
Clearance of hr-HPV and normalization of cytology (KOPAC)
Normalization of cytology (KOPAC) (depending on NVOG/RIVM flowchart).
Time frame: 12-24 months
Characteristics of the vaginal microbiome
Species specific and diversity analysis, changes due to honey and relationship with the other outcomes measures
Time frame: 0-6 months
Cervical immune status
Immunohistochemical stains on colposcopy biopsies for T and Myeloid cells
Time frame: 0 months
Human vaginal gene expression profiles
RNA quantity and quality of 20 patients
Time frame: 0 and 6 months
Quality of life, side-effects and compliance with medical grade honey
Time frame: 0, 6, 12 and 24 months
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