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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

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?


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
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Study Start Date : April 2010
Estimated Primary Completion Date : December 2010
Estimated Study Completion Date : December 2010

Arm Intervention/treatment
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




Primary Outcome Measures :
  1. 1.proportion of HPV positives in both arms [ Time Frame: 6months ]
  2. 2. proportion of regression of LSIL lesion in both arms [ Time Frame: 6 months ]


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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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)

Information from the National Library of Medicine

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


Locations
Belgium
Veronique Verhoeven Recruiting
Wilrijk, Belgium, 2610
Contact: veronique verhoeven, MD, PhD    0032 3 265 25 18    veronique.verhoeven@ua.ac.be   
Sponsors and Collaborators
Universiteit Antwerpen
Clinical cyotpathology laboratory AML
Investigators
Principal Investigator: veronique verhoeven, MD, PhD Universiteit Antwerpen

Responsible Party: Professor Veronique Verhoeven, University of Antwerp
ClinicalTrials.gov Identifier: NCT01097356     History of Changes
Other Study ID Numbers: 2414VV
First Posted: April 1, 2010    Key Record Dates
Last Update Posted: April 23, 2010
Last Verified: January 2010