The Effect of Probiotics on the Clearance of the Human Papillomavirus and on Cytological Lesions Caused by the Virus
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|ClinicalTrials.gov Identifier: NCT01097356|
Recruitment Status : Unknown
Verified January 2010 by Universiteit Antwerpen.
Recruitment status was: Recruiting
First Posted : April 1, 2010
Last Update Posted : April 23, 2010
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?
|Condition or disease||Intervention/treatment||Phase|
|HPV-related Cytological Abnormalities on PAP Smear (LSIL)||Dietary Supplement: probiotic drinkers||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||60 participants|
|Intervention Model:||Parallel Assignment|
|Study Start Date :||April 2010|
|Estimated Primary Completion Date :||December 2010|
|Estimated Study Completion Date :||December 2010|
No Intervention: common care
HPV+ patients with LSIL on their PAP smear, waiting for 6 months to receive a new PAP smear
Experimental: probiotic drinkers
HPV+, LSIL patients who will drink the study drink for 6 months
Dietary Supplement: probiotic drinkers
HPV+, LSIL patients in this arm will drink the probiotic study drink for a period of 6 months
- 1.proportion of HPV positives in both arms [ Time Frame: 6months ]
- 2. proportion of regression of LSIL lesion in both arms [ Time Frame: 6 months ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01097356
|Wilrijk, Belgium, 2610|
|Contact: veronique verhoeven, MD, PhD 0032 3 265 25 18 firstname.lastname@example.org|
|Principal Investigator:||veronique verhoeven, MD, PhD||Universiteit Antwerpen|