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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
Sponsor:
Collaborator:
Clinical cyotpathology laboratory AML
Information provided by:
Universiteit Antwerpen

March 31, 2010
April 1, 2010
April 23, 2010
April 2010
December 2010   (Final data collection date for primary outcome measure)
  • 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 ]
Same as current
Complete list of historical versions of study NCT01097356 on ClinicalTrials.gov Archive Site
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The Effect of Probiotics on the Clearance of the Human Papillomavirus and on Cytological Lesions Caused by the Virus
Not Provided

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?

Not Provided
Interventional
Not Applicable
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
HPV-related Cytological Abnormalities on PAP Smear (LSIL)
Dietary Supplement: probiotic drinkers
HPV+, LSIL patients in this arm will drink the probiotic study drink for a period of 6 months
  • 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
    Intervention: Dietary Supplement: probiotic drinkers
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Unknown status
60
Same as current
December 2010
December 2010   (Final data collection date for primary outcome measure)

Inclusion Criteria:

  • women with a new LSIL diagnosis an HPV positivity on PAP smear

Exclusion Criteria:

  • women over 65
  • immunocompromised patients (because of disease or drugs)
Sexes Eligible for Study: Female
18 Years to 65 Years   (Adult, Older Adult)
No
Contact information is only displayed when the study is recruiting subjects
Belgium
 
 
NCT01097356
2414VV
No
Not Provided
Not Provided
Professor Veronique Verhoeven, University of Antwerp
Universiteit Antwerpen
Clinical cyotpathology laboratory AML
Principal Investigator: veronique verhoeven, MD, PhD Universiteit Antwerpen
Universiteit Antwerpen
January 2010

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP