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Recruiting NCT06219018

Effect of Honey For CIN II

Phase I / Phase II Interventional Cervical Intraepithelial Neoplasia-II High Risk Human Papillomavirus

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Medical grade honey formulation (MGH) (L-Mesitran®).
Who it may be relevant to
Registry conditions: Cervical Intraepithelial Neoplasia-II, High Risk Human Papillomavirus. Basic parameters: 18 years — 40 years · Female.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Netherlands
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

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

Overview

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.

Interventions

  • 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.

Primary outcome measures

  • Clearance of hr-HPV [Time frame: 6 months]
Secondary outcome measures (6)
  • Regression of CIN II [Time frame: 12-24 months]
  • Clearance of hr-HPV and normalization of cytology (KOPAC) [Time frame: 12-24 months]
  • Characteristics of the vaginal microbiome [Time frame: 0-6 months]
  • Cervical immune status [Time frame: 0 months]
  • Human vaginal gene expression profiles [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]

Eligibility criteria

Inclusion criteria

  • Women 18-40 years
  • Primary CIN II confirmed histologically in the biopsy on colposcopic examination
  • Sufficient mastery of the Dutch language

Exclusion criteria

  • 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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Allocation
N/A
Model
Single group
Masking
Open label
Primary purpose
Treatment

Study locations

Netherlands · 2 centers
  • Zuyderland MC — Heerlen
  • Maastricht University Medical Centre+ — Maastricht

Publications

  • Prop J, De Vos van Steenwijk P, Lardenoije CMJG, Cremers NAJ, Morre SA, Mongula J. Effect of medical-grade honey (L-Mesitran) for cervical intraepithelial neoplasia II: protocol for a multicentre cohort pilot study (HONEY FOR CIN II study). BMJ Open. 2025 Jul 24;15(7):e104585. doi: 10.1136/bmjopen-2025-104585. PMID 40707147

Identifiers

NCT: NCT06219018 · NL86044.096.23

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗