Probiotc Lactobacillus Crispatus-M247 (Crispact®) Supplementation in the Sterilization of High-ri… (NCT06245486) | Clinical Trial Compass
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Probiotc Lactobacillus Crispatus-M247 (Crispact®) Supplementation in the Sterilization of High-risk Human Papilloma (HPV-HR) Viruses
150 participantsStarted 2024-02-10
Plain-language summary
There is growing scientific interest in probiotic supplementation as a possible therapy for clearing the human papillomavirus (HPV) infection and reducing the risk of developement of cervical cancer.
Who can participate
Age range18 Years – 64 Years
SexFEMALE
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Inclusion Criteria:
* Women able to understand and agree to participation in the study and be able to provide written informed consent to the trial.
* 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:
* Women who have been vaccinated for HPV.
* Patients who have undergone cervical treatments for preneoplastic pathology.
* Patients with High-Grade Squamous Intraepithelial Lesion (HSIL) cytological result who on histological examination after…
What they're measuring
1
Human papillomavirus (HPV) clearance
Timeframe: After 4-months
2
Changes in vaginal bacterial quantity (population) that colonize, called Community State Type (CST)
Timeframe: After 4-months
Trial details
NCT IDNCT06245486
SponsorLiaquat University of Medical & Health Sciences