The Effect of Probiotics on the Clearance of the Human Papillomavirus and on Cytological Lesions Caused by the Virus
|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|
|HPV-related Cytological Abnormalities on PAP Smear (LSIL)||Dietary Supplement: probiotic drinkers|
|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 ]
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|