Cervical Intraepithelial Neoplasia-IIPhase 1/2HoneyForCINIINCT06219018
Effect of Honey For CIN II
A Phase 1/2 study testing Medical grade honey formulation (MGH) (L-Mesitran®) in people with Cervical Intraepithelial Neoplasia-II and High Risk Human Papillomavirus, run by Zuyderland Medisch Centrum at 2 sites in Netherlands.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 40 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Cervical Intraepithelial Neoplasia-II, High Risk Human Papillomavirus
- What is being tested?
- Medical grade honey formulation (MGH) (L-Mesitran®)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 2 sitesNetherlands
- Study dates
- 30 Dec 2024to 1 Dec 2027
- Phase
- Phase 1/2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 40 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Women 18-40 years
- Primary CIN II confirmed histologically in the biopsy on colposcopic examination
- Sufficient mastery of the Dutch language
Who cannot join
- 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
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Netherlands2 sites, 2 recruiting
- Recruiting
Zuyderland MC
Heerlen, Limburg, 6149 PC
Jordy Mongula, Doctor, +31621872080, j.mongula@zuyderland.nl
Jasmijn Prop, Master of Science (medicine), +3624787337, j.prop@zuyderland.nl
- Not yet recruiting
Maastricht University Medical Centre+
Maastricht, Limburg, 6229 HX
Peggy De Vos - van Steenwijk, Doctor, +31641240628, peggy.de.vosvansteenwijk@mumc.nl
Jasmijn Prop, Master in Science, +31624787337, j.prop@zuyderland.nl
About this study
Official title: The Effect of Medical Grade Honey (L-Mesitran) for Cervical Intraepithelial Neoplasia-II
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.
Read the 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.
- Being tested
- Medical grade honey formulation (MGH) (L-Mesitran®)
- Keywords
- Honey CINII
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Drug: Medical grade honey formulation (MGH) (L-Mesitran®) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Clearance of hr-HPV
The following hypothesis is tested: Medical grade honey in CIN II causes a higher clearance of the hr-HPV virus
Measured: 6 months
Secondary outcomes (6)
Regression of CIN II
Defined as a regression to Pap 1
Measured: 12-24 months
Clearance of hr-HPV and normalization of cytology (KOPAC)
Normalization of cytology (KOPAC) (depending on NVOG/RIVM flowchart).
Measured: 12-24 months
Characteristics of the vaginal microbiome
Species specific and diversity analysis, changes due to honey and relationship with the other outcomes measures
Measured: 0-6 months
Cervical immune status
Immunohistochemical stains on colposcopy biopsies for T and Myeloid cells
Measured: 0 months
Human vaginal gene expression profiles
RNA quantity and quality of 20 patients
Measured: 0 and 6 months
Quality of life, side-effects and compliance with medical grade honey
Measured: 0, 6, 12 and 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jan 2024
- Study start30 Dec 2024
- Primary completion1 Dec 2026 (estimated)
- Study completion1 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Cervical Intraepithelial Neoplasia-IIStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model 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 the potential effect of honey and provides insight into its mechanisms of action.
- Masking
- None (open label)
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Zuyderland Medisch Centrum
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06219018
- Sponsor's protocol ID
- NL86044.096.23
- Acronym
- HoneyForCINII
- Status last verified
- Jun 2025
- First submitted
- 11 Jan 2024
- Last updated
- 18 Jun 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Deidentified participant data will be shared.
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.
PubMed 40707147
Study at a glance
From the registry record, last updated by the sponsor on 18 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Medical Grade Honey (L-Mesitran) for Cervical Intraepithelial Neoplasia-II
- ClinicalTrials.gov ID
- NCT06219018
- Acronym / sponsor ID
- HoneyForCINII / NL86044.096.23
- Keywords
- Honey CINII
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Zuyderland Medisch CentrumUniversity, hospital or other
- Study start
- 30 Dec 2024 (actual)
- Primary completion
- 1 Dec 2026 (estimated)
- Study completion
- 1 Dec 2027 (estimated)
- First posted
- 23 Jan 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model 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 the potential effect of honey and provides insight into its mechanisms of action.
| Arm | Type | Receives |
|---|---|---|
| Medical grade honey formulation (MGH) (L-Mesitran®) for CIN II | Experimental | Drug: Medical grade honey formulation (MGH) (L-Mesitran®)Daily application of 5 grams (with applicator) for 3 months. Then weekly application (5 grams with applicator) for 3 months. |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Women 18-40 years
- Primary CIN II confirmed histologically in the biopsy on colposcopic examination
- Sufficient mastery of the Dutch language
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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. | Drug | Medical grade honey formulation (MGH) (L-Mesitran®) for CIN II |
Primary outcome
Clearance of hr-HPV
Time frame: 6 months
The following hypothesis is tested: Medical grade honey in CIN II causes a higher clearance of the hr-HPV virus
6 secondary outcomes
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Jun 2025.
- Derived from this study: PubMed 40707147Prop 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.
- Individual participant dataSharing planned: Yes. Deidentified participant data will be shared.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Medical grade honey formulation (MGH) (L-Mesitran®) in people with Cervical Intraepithelial Neoplasia-II and High Risk Human Papillomavirus, run by Zuyderland Medisch Centrum at 2 sites in Netherlands.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 18 Jun 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Jordy Mongula, dr. (+31621872080 ext. 19264, j.mongula@zuyderland.nl), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Clearance of hr-HPV (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06219018, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Jun 2025.