Probiotc Lactobacillus Crispatus-M247 (Crispact®) Supplementation in the Sterilization of High-risk Human Papilloma (HPV-HR) Viruses
NCT ID: NCT06245486
Last Updated: 2024-02-07
Study Results
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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NOT_YET_RECRUITING
NA
150 participants
INTERVENTIONAL
2024-02-10
2025-03-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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Probiotic Young Group (Women aged 18-29 years)
Participants in this group will take probiotic Crispact® (20 Bld CFU/Stick of Lactobacillus crispatus M247) as 1 oral sachet per day for four months and 1 sachet in vaginal lavage for the first 10 days of treatment.
Crispact®
Contains 20 Bld CFU/Stick of probiotic Lactobacillus crispatus M247
Control Young Group (Women aged 18-29 years)
Participants in this group will take Placebo as 1 oral sachet per day for four months and 1 sachet in vaginal lavage for the first 10 days of treatment.
Placebo
Placebo
Probiotic Lady Group (Women aged 30-64 years)
Participants in this group will take probiotic Crispact® (20 Bld CFU/Stick of Lactobacillus crispatus M247) as 1 sachet oral per day for four months and 1 sachet in vaginal lavage for the first 10 days of treatment.
Crispact®
Contains 20 Bld CFU/Stick of probiotic Lactobacillus crispatus M247
Control Lady Group (Women aged 18-29 years)
Participants in this group will take Placebo as 1 oral sachet per day for four months and 1 sachet in vaginal lavage for the first 10 days of treatment.
Placebo
Placebo
Interventions
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Crispact®
Contains 20 Bld CFU/Stick of probiotic Lactobacillus crispatus M247
Placebo
Placebo
Eligibility Criteria
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Inclusion Criteria
* Women aged 25-29 years who perform screening pap smears with the result: Low- grade squamous intraepithelial lesion (LSIL) or Atypical Squamous Cells of Undetermined Significanc (ASCUS) (for which, as per the recommendation of the Italian Society of Colposcopy and Cervico-Vaginal Pathology (SICPCV)/Italian Group of Cervical Cancer. Screening (GISCI), no treatment is indicated but only follow-up with Human papillomavirus (HPV) test at 12 months.
* Women aged 18-64 who independently perform a positive High risk sub-types of HPV (HR-HPV) test outside of screening even in the presence of a negative cytology (for whom, as per the recommendation of the SICPCV, no treatment is indicated but only follow-up with HPV test at 12 months).
* Women aged 30-64 years HPV HR positive with negative cytology or with positive cytology for ASCUS or LSIL but negative colposcopy (absence of colposcopic lesion or positive colposcopy but subsequent negative biopsy) who do not require treatment (therefore as per the recommendation of the SICPCV go to follow-up with HPV testing at 12 months).
Exclusion Criteria
* Patients who have undergone cervical treatments for preneoplastic pathology.
* Patients with High-Grade Squamous Intraepithelial Lesion (HSIL) cytological result who on histological examination after biopsy need treatment according to the SICPCV 2019 recommendations.
* Hypersensitivity to one or more components of the product.
* Patients being treated with antibiotic, immunomodulatory and immunosuppressive therapies.
* Patients with immune system or neoplastic pathologies being treated with chemotherapy
* Patients who are pregnant, breastfeeding, or planning to become pregnant in the next 6 months.
18 Years
64 Years
FEMALE
No
Sponsors
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Università degli Studi dell'Insubria
OTHER
Liaquat University of Medical & Health Sciences
OTHER
Responsible Party
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Dr. Amjad Khan
Professor of Clinical Biochemistry and Experimental Medicine
Central Contacts
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Dr. Amjad Khan, DPhil
Role: CONTACT
Other Identifiers
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774/18.10.2021
Identifier Type: -
Identifier Source: org_study_id
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