NCT06219018

Effect of Honey For CIN II

The Effect of Medical Grade Honey (L-Mesitran) for Cervical Intraepithelial Neoplasia-II

• Status: Recruiting
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 60 (estimated)
• Sponsor: Zuyderland Medisch Centrum · Academic / Other
• Sex: Female
• Age: 18 Years – 40 Years
• Healthy volunteers: Accepted

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 aims to investigate if there is a potential effect of honey and provides insight into its mechanisms of action.

Conditions

• Cervical Intraepithelial Neoplasia-II
• High Risk Human Papillomavirus

Interventions

Type	Name	Description
DRUG	Medical grade honey formulation (MGH) (L-Mesitran®)	Daily application of 5 grams (with applicator) for the first 3 months, followed by weekly application of 5 grams for the following 3 months.

Timeline

• Start date: 2024-12-30
• Primary completion: 2026-12-01
• Completion: 2027-12-01
• First posted: 2024-01-23
• Last updated: 2025-06-18

Locations

2 sites across 1 country: Netherlands