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?

Completed

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Key information

Conditions

HPV-related Cytological Abnormalities on PAP Smear (LSIL) Morphological and Microscopic Findings Pathological Conditions, Signs and Symptoms Squamous Intraepithelial Lesions

Age range

18 year–65 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Veronique Verhoeven

Wilrijk, 2610, Belgium

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

probiotic drinkers

Dietary Supplement

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

Primary outcomes

1.proportion of HPV positives in both arms

Time frame: 6months
2. proportion of regression of LSIL lesion in both arms

Time frame: 6 months

Sponsors and collaborators

Lead sponsor

Universiteit Antwerpen

Other

Registry information

Important dates

Study start: 2010
Primary completion: 2011
Study completion: 2011
First posted: Apr 1, 2010
Registry last updated: Oct 1, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed