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

Universiteit Antwerpen

Status: Completed

Conditions: HPV-related Cytological Abnormalities on PAP Smear (LSIL)

Treatments: Dietary Supplement: probiotic drinkers

Study type: Interventional

Funder types: Other

Identifiers

NCT01097356

2414VV

Details and patient eligibility

About

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?

Enrollment: 60 patients

Sex: Female

Ages: 18 to 65 years old

Volunteers: No 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)

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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60 participants in 2 patient groups

common care

No Intervention group

Description:

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

probiotic drinkers

Experimental group

Description:

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

Treatment:

Dietary Supplement: probiotic drinkers