Ignite Creation Date:
2025-12-24 @ 11:18 PM
Ignite Modification Date:
2025-12-31 @ 3:41 PM
Study NCT ID:
NCT01097356
Status:
COMPLETED
Last Update Posted:
2021-10-01
First Post:
2010-03-31
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
The Effect of Probiotics on the Clearance of the Human Papillomavirus and on Cytological Lesions Caused by the Virus
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000081483', 'term': 'Squamous Intraepithelial Lesions'}], 'ancestors': [{'id': 'D065308', 'term': 'Morphological and Microscopic Findings'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 60}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2010-04'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-09', 'completionDateStruct': {'date': '2011-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-09-28', 'studyFirstSubmitDate': '2010-03-31', 'studyFirstSubmitQcDate': '2010-03-31', 'lastUpdatePostDateStruct': {'date': '2021-10-01', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2010-04-01', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2011-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': '1.proportion of HPV positives in both arms', 'timeFrame': '6months'}, {'measure': '2. proportion of regression of LSIL lesion in both arms', 'timeFrame': '6 months'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['HPV-related Cytological Abnormalities on PAP Smear (LSIL)']}, 'descriptionModule': {'briefSummary': 'Aim: In this project proposition the investigators would like to examine the effect of immune modulation by probiotics on the clearance of HPV-infections.\n\nThis study provides a model for viral infection but also for cancer precursors. This would be an excellent model (and the only possible short-term model) to examine an effect on cancer precursors. Cancer precursors (cytological abnormalities such as L-SIL) are a scientifically accepted surrogate endpoint for cervical cancer, for example in HPV-vaccine studies.\n\nResearch question: Does daily intake of probiotics lead to a better immune-response in HPV-infected women, i.e. does it facilitate clearance of the virus and/or regression of cytological lesions?'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* women with a new LSIL diagnosis an HPV positivity on PAP smear\n\nExclusion Criteria:\n\n* women over 65\n* immunocompromised patients (because of disease or drugs)'}, 'identificationModule': {'nctId': 'NCT01097356', 'briefTitle': 'The Effect of Probiotics on the Clearance of the Human Papillomavirus and on Cytological Lesions Caused by the Virus', 'organization': {'class': 'OTHER', 'fullName': 'Universiteit Antwerpen'}, 'orgStudyIdInfo': {'id': '2414VV'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'NO_INTERVENTION', 'label': 'common care', 'description': 'HPV+ patients with LSIL on their PAP smear, waiting for 6 months to receive a new PAP smear'}, {'type': 'EXPERIMENTAL', 'label': 'probiotic drinkers', 'description': 'HPV+, LSIL patients who will drink the study drink for 6 months', 'interventionNames': ['Dietary Supplement: probiotic drinkers']}], 'interventions': [{'name': 'probiotic drinkers', 'type': 'DIETARY_SUPPLEMENT', 'description': 'HPV+, LSIL patients in this arm will drink the probiotic study drink for a period of 6 months', 'armGroupLabels': ['probiotic drinkers']}]}, 'contactsLocationsModule': {'locations': [{'zip': '2610', 'city': 'Wilrijk', 'country': 'Belgium', 'facility': 'Veronique Verhoeven', 'geoPoint': {'lat': 51.16734, 'lon': 4.39513}}], 'overallOfficials': [{'name': 'veronique verhoeven, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Universiteit Antwerpen'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Universiteit Antwerpen', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'professor', 'investigatorFullName': 'Veronique Verhoeven', 'investigatorAffiliation': 'Universiteit Antwerpen'}}}}