A Phase 1/2 interventional study of Medical grade honey formulation (MGH) (L-Mesitran®) in Cervical Intraepithelial Neoplasia-II and High Risk Human Papillomavirus, sponsored by Zuyderland Medisch Centrum. Recruiting at 2 sites in Netherlands. Open to female participants aged 18 Years to 40 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2025-06-18.
Sponsored by Zuyderland Medisch Centrum · Phase 1/2, Interventional, and Treatment
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.
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.
409 studies on the registry are indexed under Uterine Cervical Dysplasia; 76 are open to participants now.
This study's planned enrollment of 60 is below the median of 167 across 285 interventional studies indexed under Uterine Cervical Dysplasia.
Browse Uterine Cervical Dysplasia studies →Zuyderland Medisch Centrum is the lead sponsor of 64 studies on the registry; 15 are open to participants now.
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Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
A biopsy takes a small piece of tissue to examine. “Archival tissue” is a sample already taken, for example at diagnosis, and kept by the hospital.
Whether a stored sample will do depends on when it was taken, how much there is and what the study needs. Ask whether the study accepts your stored sample or needs a new biopsy.
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
A condition in which the immune system attacks the body’s own tissues, such as rheumatoid arthritis, lupus, psoriasis, type 1 diabetes or inflammatory bowel disease.
Immunotherapy studies often leave out active autoimmune disease, and some name exceptions, such as thyroid disease on replacement hormone. Check the exceptions this study lists.
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Biopsy and archival tissue
A biopsy takes a small piece of tissue to examine. “Archival tissue” is a sample already taken, for example at diagnosis, and kept by the hospital.
Whether a stored sample will do depends on when it was taken, how much there is and what the study needs. Ask whether the study accepts your stored sample or needs a new biopsy.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Immunosuppression
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Autoimmune disease
A condition in which the immune system attacks the body’s own tissues, such as rheumatoid arthritis, lupus, psoriasis, type 1 diabetes or inflammatory bowel disease.
Immunotherapy studies often leave out active autoimmune disease, and some name exceptions, such as thyroid disease on replacement hormone. Check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
HIV
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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®)
Daily application of 5 grams (with applicator) for the first 3 months, followed by weekly application of 5 grams for the following 3 months.
Clearance of hr-HPV
The following hypothesis is tested: Medical grade honey in CIN II causes a higher clearance of the hr-HPV virus
Time frame: 6 months
Regression of CIN II
Defined as a regression to Pap 1
Time frame: 12-24 months
Clearance of hr-HPV and normalization of cytology (KOPAC)
Normalization of cytology (KOPAC) (depending on NVOG/RIVM flowchart).
Time frame: 12-24 months
Characteristics of the vaginal microbiome
Species specific and diversity analysis, changes due to honey and relationship with the other outcomes measures
Time frame: 0-6 months
Cervical immune status
Immunohistochemical stains on colposcopy biopsies for T and Myeloid cells
Time frame: 0 months
Human vaginal gene expression profiles
RNA quantity and quality of 20 patients
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
Plan to share: Yes — Deidentified participant data will be shared.
Supporting information: 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).'
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Zuyderland Medisch Centrum