HPV infection clearance with glucan and probiotics

Not Applicable

• Conditions: HPV infection; Infections and Infestations

• Registration Number: ISRCTN62596811
• Lead Sponsor: Ospedale dei Bambini Vittore Buzzi

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2022-09-11
• Last Update Posted: 19 September 2022
• Study Completion: 2023-06-30

Recruitment & Eligibility

• Status: Ongoing
• Sex: Female
• Target Recruitment: 80

Inclusion Criteria

1. Women aged 30-45 years
2. Persistent positive cytological LSIL and/or histological CIN 1 and/or HPV HR test for at least 12 months
3. Absence of contraindications to the proposed therapies
4. Read and signed informed consent

Exclusion Criteria

1. Active vulvovaginal infections at the time of their gynaecological examination
2. Genital bleeding of unknown origin
3. Pregnancy
4. Menopause (absence of menstruation for 12 months)
5. Diagnosis of or under therapy for previous CIN2+ lesions
6. Immune-depressed, or with infections caused by human immunodeficiency virus (HIV-positive)
7. Patients concomitantly included in different interventional clinical trials
8. Unwillingness to provide informed consent to the trial

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
HR-HPV clearance measured using PCR at 6 months

Secondary Outcome Measures

Name	Time	Method
SIL/CIN 1 regression measured using Pap smear/histology at 6 months