Effect of Honey For CIN II

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

PHASE1/PHASE2

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-12-30

Study Completion Date

2027-12-01

Brief Summary

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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.

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Detailed Description

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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

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Cervical Intraepithelial Neoplasia-II High Risk Human Papillomavirus

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

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.

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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

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

Group Type EXPERIMENTAL

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

Intervention Type 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.

Interventions

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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.

Intervention Type DRUG

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

40 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes