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

Primary Purpose

HPV-related Cytological Abnormalities on PAP Smear (LSIL)

Status

Completed

Phase

Not Applicable

Locations

Belgium

Study Type

Interventional

Intervention

probiotic drinkers

About this trial

This is an interventional treatment trial for HPV-related Cytological Abnormalities on PAP Smear (LSIL)

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)FemaleDoes not accept healthy volunteers

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)

Sites / Locations

Veronique Verhoeven

Arms of the Study

Arm 1

Arm 2

Arm Type

No Intervention

Experimental

Arm Label

common care

probiotic drinkers

Arm Description

HPV+ patients with LSIL on their PAP smear, waiting for 6 months to receive a new PAP smear

HPV+, LSIL patients who will drink the study drink for 6 months

Outcomes

Primary Outcome Measures

1.proportion of HPV positives in both arms

2. proportion of regression of LSIL lesion in both arms

Secondary Outcome Measures

Full Information

NCT ID

NCT01097356

First Posted

March 31, 2010

Last Updated

September 28, 2021

Sponsor

Universiteit Antwerpen

1. Study Identification

Unique Protocol Identification Number

NCT01097356

Brief Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

September 2021

Overall Recruitment Status

Completed

Study Start Date

April 2010 (undefined)

Primary Completion Date

December 2011 (Actual)

Study Completion Date

December 2011 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Universiteit Antwerpen

4. Oversight

Data Monitoring Committee

5. Study Description

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?

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

HPV-related Cytological Abnormalities on PAP Smear (LSIL)

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

Participant

Allocation

Randomized

Enrollment

60 (Actual)

8. Arms, Groups, and Interventions

Arm Title

common care

Arm Type

No Intervention

Arm Description

HPV+ patients with LSIL on their PAP smear, waiting for 6 months to receive a new PAP smear

Arm Title

probiotic drinkers

Arm Type

Experimental

Arm Description

HPV+, LSIL patients who will drink the study drink for 6 months

Intervention Type

Dietary Supplement

Intervention Name(s)

probiotic drinkers

Intervention Description

HPV+, LSIL patients in this arm will drink the probiotic study drink for a period of 6 months

Primary Outcome Measure Information:

Title

1.proportion of HPV positives in both arms

Time Frame

6months

Title

2. proportion of regression of LSIL lesion in both arms

Time Frame

6 months

10. Eligibility

Sex

Female

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

65 Years

Accepts Healthy Volunteers

Eligibility 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)

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

veronique verhoeven, MD, PhD

Organizational Affiliation

Universiteit Antwerpen

Official's Role

Principal Investigator

Facility Information:

Facility Name

Veronique Verhoeven

City

Wilrijk

ZIP/Postal Code

2610

Country

Belgium

12. IPD Sharing Statement

Learn more about this trial

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

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