The Effect of Probiotics on the Clearance of the Human Papillomavirus and on Cytological Lesions Caused by the Virus
- Conditions
- HPV-related Cytological Abnormalities on PAP Smear (LSIL)
- Interventions
- Dietary Supplement: probiotic drinkers
- Registration Number
- NCT01097356
- Lead Sponsor
- Universiteit Antwerpen
- Brief Summary
Aim: In this project proposition the investigators would like to examine the effect of immune modulation by probiotics on the clearance of HPV-infections.
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?
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Female
- Target Recruitment
- 60
- women with a new LSIL diagnosis an HPV positivity on PAP smear
- women over 65
- immunocompromised patients (because of disease or drugs)
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description probiotic drinkers probiotic drinkers HPV+, LSIL patients who will drink the study drink for 6 months
- Primary Outcome Measures
Name Time Method 2. proportion of regression of LSIL lesion in both arms 6 months 1.proportion of HPV positives in both arms 6months
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
Veronique Verhoeven
🇧🇪Wilrijk, Belgium