Using medical grade honey to treat cervical pre-cancer
The Effect of Medical Grade Honey (L-Mesitran) for Cervical Intraepithelial Neoplasia-II
This study is testing if medical grade honey can help women with cervical pre-cancer and high-risk HPV get better compared to those who don’t use honey.
Quick facts
| Phase | Phase1; Phase2 |
|---|---|
| Study type | Interventional |
| Enrollment | 60 (estimated) |
| Ages | 18 Years to 40 Years |
| Sex | Female |
| Sponsor | Zuyderland Medisch Centrum Academic / other |
| Locations | 2 sites (Heerlen, Limburg and 1 other locations) |
| Trial ID | NCT06219018 on ClinicalTrials.gov |
What this trial studies
This pilot study investigates the effects of medical grade honey on women diagnosed with cervical intraepithelial neoplasia II (CIN II) and high-risk human papillomavirus (hr-HPV). It includes 60 patients who will receive honey treatment as part of an expectant management approach, while a control group will not use honey. Follow-up assessments will occur at six months, including swabs for vaginal microbiota analysis and immunohistochemical evaluations of immune responses. The study aims to determine if honey can enhance the clearance of hr-HPV and normalize CIN II lesions compared to standard management.
Who should consider this trial
Good fit: Ideal candidates are women aged 18-40 with a confirmed diagnosis of CIN II.
Not a fit: Patients with concurrent cervical abnormalities, hr-HPV negative cytology, or those with a history of cervical carcinoma may not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could provide a non-invasive alternative for managing CIN II and improving patient outcomes.
How similar studies have performed: While the use of honey in medical treatments is not widely studied, this approach is novel and has not been extensively tested in the context of CIN II.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Heerlen, Limburg and 1 other locations
- Zuyderland MC — Heerlen, Limburg, Netherlands (Recruiting)
- Maastricht University Medical Centre+ — Maastricht, Limburg, Netherlands (Not_yet_recruiting)
Study contacts
- Study coordinator: Jordy Mongula, dr.
- Email: j.mongula@zuyderland.nl
- Phone: +31621872080
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.