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

NCT ID: NCT01097356

Last Updated: 2021-10-01

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-04-30

Study Completion Date

2011-12-31

Brief Summary

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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?

Detailed Description

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Conditions

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HPV-related Cytological Abnormalities on PAP Smear (LSIL)

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

Study Groups

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common care

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

Group Type NO_INTERVENTION

No interventions assigned to this group

probiotic drinkers

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

Group Type EXPERIMENTAL

probiotic drinkers

Intervention Type DIETARY_SUPPLEMENT

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

Interventions

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probiotic drinkers

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

Intervention Type DIETARY_SUPPLEMENT

Eligibility Criteria

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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)
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Universiteit Antwerpen

OTHER

Sponsor Role lead

Responsible Party

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Veronique Verhoeven

professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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veronique verhoeven, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Universiteit Antwerpen

Locations

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Veronique Verhoeven

Wilrijk, , Belgium

Site Status

Countries

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Belgium

Other Identifiers

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2414VV

Identifier Type: -

Identifier Source: org_study_id

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