Ignite Creation Date:
2025-12-25 @ 4:58 AM
Ignite Modification Date:
2025-12-26 @ 3:58 AM
Study NCT ID:
NCT06219018
Status:
RECRUITING
Last Update Posted:
2025-06-18
First Post:
2024-01-11
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Effect of Honey For CIN II
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['PHASE1', 'PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP', 'interventionModelDescription': '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.'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 60}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2024-12-30', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-06', 'completionDateStruct': {'date': '2027-12-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-06-13', 'studyFirstSubmitDate': '2024-01-11', 'studyFirstSubmitQcDate': '2024-01-11', 'lastUpdatePostDateStruct': {'date': '2025-06-18', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-01-23', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-12-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Clearance of hr-HPV', 'timeFrame': '6 months', 'description': 'The following hypothesis is tested: Medical grade honey in CIN II causes a higher clearance of the hr-HPV virus'}], 'secondaryOutcomes': [{'measure': 'Regression of CIN II', 'timeFrame': '12-24 months', 'description': 'Defined as a regression to Pap 1'}, {'measure': 'Clearance of hr-HPV and normalization of cytology (KOPAC)', 'timeFrame': '12-24 months', 'description': 'Normalization of cytology (KOPAC) (depending on NVOG/RIVM flowchart).'}, {'measure': 'Characteristics of the vaginal microbiome', 'timeFrame': '0-6 months', 'description': 'Species specific and diversity analysis, changes due to honey and relationship with the other outcomes measures'}, {'measure': 'Cervical immune status', 'timeFrame': '0 months', 'description': 'Immunohistochemical stains on colposcopy biopsies for T and Myeloid cells'}, {'measure': 'Human vaginal gene expression profiles', 'timeFrame': '0 and 6 months', 'description': 'RNA quantity and quality of 20 patients'}, {'measure': 'Quality of life, side-effects and compliance with medical grade honey', 'timeFrame': '0, 6, 12 and 24 months'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Honey CINII'], 'conditions': ['Cervical Intraepithelial Neoplasia-II', 'High Risk Human Papillomavirus']}, 'referencesModule': {'references': [{'pmid': '40707147', 'type': 'DERIVED', 'citation': '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.'}]}, 'descriptionModule': {'briefSummary': '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.', 'detailedDescription': '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.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT'], 'maximumAge': '40 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Women 18-40 years\n* Primary CIN II confirmed histologically in the biopsy on colposcopic examination\n* Sufficient mastery of the Dutch language\n\nExclusion Criteria:\n\n* Simultaneous abnormality in columnar epithelial cells (AIS).\n* Hr-HPV negative cytology\n* Immunosuppressant use/Autoimmune disease (HIV, CVID)\n* History of cervical carcinoma or previous treatment for CIN (LLETZ or imiquimod)\n* Pregnancy or the intention to become pregnant during the study period\n* Legal incompetence\n* Known allergies to honey'}, 'identificationModule': {'nctId': 'NCT06219018', 'acronym': 'HoneyForCINII', 'briefTitle': 'Effect of Honey For CIN II', 'organization': {'class': 'OTHER', 'fullName': 'Zuyderland Medisch Centrum'}, 'officialTitle': 'The Effect of Medical Grade Honey (L-Mesitran) for Cervical Intraepithelial Neoplasia-II', 'orgStudyIdInfo': {'id': 'NL86044.096.23'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Medical grade honey formulation (MGH) (L-Mesitran®) for CIN II', 'description': 'Daily application of 5 grams (with applicator) for 3 months. Then weekly application (5 grams with applicator) for 3 months.', 'interventionNames': ['Drug: Medical grade honey formulation (MGH) (L-Mesitran®)']}], 'interventions': [{'name': 'Medical grade honey formulation (MGH) (L-Mesitran®)', 'type': 'DRUG', 'description': 'Daily application of 5 grams (with applicator) for the first 3 months, followed by weekly application of 5 grams for the following 3 months.', 'armGroupLabels': ['Medical grade honey formulation (MGH) (L-Mesitran®) for CIN II']}]}, 'contactsLocationsModule': {'locations': [{'zip': '6149 PC', 'city': 'Heerlen', 'state': 'Limburg', 'status': 'RECRUITING', 'country': 'Netherlands', 'contacts': [{'name': 'Jordy Mongula, Doctor', 'role': 'CONTACT', 'email': 'j.mongula@zuyderland.nl', 'phone': '+31621872080'}, {'name': 'Jasmijn Prop, Master of Science (medicine)', 'role': 'CONTACT', 'email': 'j.prop@zuyderland.nl', 'phone': '+3624787337'}, {'name': 'Jordy Mongula, Doctor', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Zuyderland MC', 'geoPoint': {'lat': 50.88365, 'lon': 5.98154}}, {'zip': '6229 HX', 'city': 'Maastricht', 'state': 'Limburg', 'status': 'NOT_YET_RECRUITING', 'country': 'Netherlands', 'contacts': [{'name': 'Peggy De Vos - van Steenwijk, Doctor', 'role': 'CONTACT', 'email': 'peggy.de.vosvansteenwijk@mumc.nl', 'phone': '+31641240628'}, {'name': 'Jasmijn Prop, Master in Science', 'role': 'CONTACT', 'email': 'j.prop@zuyderland.nl', 'phone': '+31624787337'}, {'name': 'Jasmijn Prop, Master in Science', 'role': 'SUB_INVESTIGATOR'}], 'facility': 'Maastricht University Medical Centre+', 'geoPoint': {'lat': 50.84833, 'lon': 5.68889}}], 'centralContacts': [{'name': 'Jordy Mongula, dr.', 'role': 'CONTACT', 'email': 'j.mongula@zuyderland.nl', 'phone': '+31621872080', 'phoneExt': '19264'}, {'name': 'Jasmijn Prop, Drs.', 'role': 'CONTACT', 'email': 'j.prop@zuyderland.nl', 'phone': '+31524787337'}]}, 'ipdSharingStatementModule': {'infoTypes': ['STUDY_PROTOCOL'], 'timeFrame': 'Data will be available after publication of results.', 'ipdSharing': 'YES', 'description': 'Deidentified participant data will be shared.', 'accessCriteria': "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).'"}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Zuyderland Medisch Centrum', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}