The Effect of Probiotics on the Clearance of the Human Papillomavirus and on Cytological Lesions Caused by the Virus
NCT ID: NCT01097356
Last Updated: 2021-10-01
Study Results
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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COMPLETED
NA
60 participants
INTERVENTIONAL
2010-04-30
2011-12-31
Brief Summary
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This 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.
Research 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?
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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common care
HPV+ patients with LSIL on their PAP smear, waiting for 6 months to receive a new PAP smear
No interventions assigned to this group
probiotic drinkers
HPV+, LSIL patients who will drink the study drink for 6 months
probiotic drinkers
HPV+, LSIL patients in this arm will drink the probiotic study drink for a period of 6 months
Interventions
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probiotic drinkers
HPV+, LSIL patients in this arm will drink the probiotic study drink for a period of 6 months
Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
* immunocompromised patients (because of disease or drugs)
18 Years
65 Years
FEMALE
No
Sponsors
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Universiteit Antwerpen
OTHER
Responsible Party
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Veronique Verhoeven
professor
Principal Investigators
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veronique verhoeven, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
Universiteit Antwerpen
Locations
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Veronique Verhoeven
Wilrijk, , Belgium
Countries
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Other Identifiers
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2414VV
Identifier Type: -
Identifier Source: org_study_id
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