Effect of Honey For CIN II

NCT06219018 | Recruiting Phase 1

• 1 other identifier: NL86044.096.23
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 2

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.

Conditions

Cervical Intraepithelial Neoplasia-II; High Risk Human Papillomavirus

Keywords

Honey CINII

Outcome Measures

Primary Outcomes (1)

• Clearance of hr-HPV

  The following hypothesis is tested: Medical grade honey in CIN II causes a higher clearance of the hr-HPV virus

  6 months

Secondary Outcomes (6)

• Regression of CIN II

  12-24 months

• Clearance of hr-HPV and normalization of cytology (KOPAC)

  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

Study Arms (1)

Medical grade honey formulation (MGH) (L-Mesitran®) for CIN II

EXPERIMENTAL

Daily application of 5 grams (with applicator) for 3 months. Then weekly application (5 grams with applicator) for 3 months.

Drug: Medical grade honey formulation (MGH) (L-Mesitran®)

Interventions

Medical grade honey formulation (MGH) (L-Mesitran®) DRUG

Daily application of 5 grams (with applicator) for the first 3 months, followed by weekly application of 5 grams for the following 3 months.

Medical grade honey formulation (MGH) (L-Mesitran®) for CIN II

Eligibility Criteria

• Age: 18 Years - 40 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Zuyderland Medisch Centrum: lead

Study Sites (2)

Zuyderland MC

Heerlen, Limburg, 6149 PC, Netherlands

RECRUITING

Maastricht University Medical Centre+

Maastricht, Limburg, 6229 HX, Netherlands

NOT YET RECRUITING

Related Publications (1)

• 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 DERIVED

Central Study Contacts

Jordy Mongula, dr.

CONTACT

+31621872080; j.mongula@zuyderland.nl

Jasmijn Prop, Drs.

CONTACT

+31524787337; j.prop@zuyderland.nl

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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 the potential effect of honey and provides insight into its mechanisms of action.

Study Record Dates

• First Submitted: January 11, 2024
• First Posted: January 23, 2024
• Study Start: December 30, 2024
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): December 1, 2027
• Last Updated: June 18, 2025

Record last verified: 2025-06

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL
• Time Frame: Data will be available after publication of results.
• Access Criteria: The data sharing plan includes that data (deidentified participant data) is available upon reasonable request from the corresponding author. This data could be used for further research or a meta-analysis on the use of medical grade honey for CIN II lesions. Data will be available after publication of results. Data can be available from the corresponding author J.N.M.M. Prop (https://orcid.org/0009-0009-8506-5797).'

Locations

NL (2)