The Effect of Probiotics on the Clearance of the Human Papillomavirus and on Cytological Lesions Caused by the Virus

The recruitment status of this study is unknown because the information has not been verified recently.
Verified January 2010 by Universiteit Antwerpen.
Recruitment status was  Recruiting
Sponsor:
Collaborator:
Clinical cyotpathology laboratory AML
Information provided by:
Universiteit Antwerpen
ClinicalTrials.gov Identifier:
NCT01097356
First received: March 31, 2010
Last updated: April 22, 2010
Last verified: January 2010
  Purpose

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 Intervention
HPV-related Cytological Abnormalities on PAP Smear (LSIL)
Dietary Supplement: probiotic drinkers

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Treatment

Resource links provided by NLM:


Further study details as provided by Universiteit Antwerpen:

Primary Outcome Measures:
  • 1.proportion of HPV positives in both arms [ Time Frame: 6months ] [ Designated as safety issue: No ]
  • 2. proportion of regression of LSIL lesion in both arms [ Time Frame: 6 months ] [ Designated as safety issue: No ]

Estimated Enrollment: 60
Study Start Date: April 2010
Estimated Study Completion Date: December 2010
Estimated Primary Completion Date: December 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders 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)
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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
  More Information

No publications provided

Responsible Party: Professor Veronique Verhoeven, University of Antwerp
ClinicalTrials.gov Identifier: NCT01097356     History of Changes
Other Study ID Numbers: 2414VV
Study First Received: March 31, 2010
Last Updated: April 22, 2010
Health Authority: Belgium: Institutional Review Board

Additional relevant MeSH terms:
Congenital Abnormalities

ClinicalTrials.gov processed this record on August 28, 2014