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

NCT01097356 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 60

Last updated 2021-10-01

No results posted yet for this study

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?

Conditions

  • HPV-related Cytological Abnormalities on PAP Smear (LSIL)

Interventions

DIETARY_SUPPLEMENT

probiotic drinkers

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

Sponsors & Collaborators

  • Universiteit Antwerpen

    lead OTHER

Principal Investigators

  • veronique verhoeven, MD, PhD · Universiteit Antwerpen

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2010-04-30
Primary Completion
2011-12-31
Completion
2011-12-31

Countries

  • Belgium

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01097356 on ClinicalTrials.gov