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

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?

Study Overview

• Status: Completed
• Conditions: HPV-related Cytological Abnormalities on PAP Smear (LSIL)
• Intervention / Treatment: Dietary supplement: probiotic drinkers

• Study Type: Interventional
• Enrollment (Actual): 60
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Belgium
  • Wilrijk, Belgium, 2610
    • Veronique Verhoeven

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years to 63 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
1.proportion of HPV positives in both arms	6months
2. proportion of regression of LSIL lesion in both arms	6 months

Collaborators and Investigators

• Sponsor: Universiteit Antwerpen
• Investigators: Principal Investigator: veronique verhoeven, MD, PhD, Universiteit Antwerpen

Study record dates

Study Major Dates

• Study Start: April 1, 2010
• Primary Completion (Actual): December 1, 2011
• Study Completion (Actual): December 1, 2011

Study Registration Dates

• First Submitted: March 31, 2010
• First Submitted That Met QC Criteria: March 31, 2010
• First Posted (Estimate): April 1, 2010

Study Record Updates

• Last Update Posted (Actual): October 1, 2021
• Last Update Submitted That Met QC Criteria: September 28, 2021
• Last Verified: September 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Congenital Abnormalities
• Other Study ID Numbers: 2414VV