Probiotc Lactobacillus Crispatus-M247 (Crispact®) Supplementation in the Sterilization of High-risk Human Papilloma (HPV-HR) Viruses

Not Applicable

Not yet recruiting

• Conditions: Human Papillomavirus Infection
• Interventions: Dietary Supplement: Placebo; Dietary Supplement: Crispact®

• Registration Number: NCT06245486
• Lead Sponsor: Liaquat University of Medical & Health Sciences

Brief 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.

Detailed Description

This is a multicenter, randomized, longitudinal, prospective, parallel-group, single-blind study aimed to investigate the efficacy of probiotic Crispact® (which contains: 20 Bld CFU/Stick of Lactobacillus crispatus M247) in clearance of human papillomavirus (HPV) infection in healthy female who tested positive for human papillomavirus (HPV) infection.

Study Timeline

• Study First Submitted: 2024-01-20
• Status Verified: 2024-02
• Study First Submitted QC: 2024-02-03
• Last Update Submitted: 2024-02-03
• Study First Posted: 2024-02-07
• Last Update Posted: 2024-02-07
• Study Start: 2024-02-10
• Primary Completion: 2024-12-31
• Study Completion: 2025-03-31

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: Female
• Target Recruitment: 150

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 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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Control Lady Group (Women aged 18-29 years)	Placebo	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.
Probiotic Lady Group (Women aged 30-64 years)	Crispact®	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.
Probiotic Young Group (Women aged 18-29 years)	Crispact®	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.
Control Young Group (Women aged 18-29 years)	Placebo	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.

Primary Outcome Measures

Name	Time	Method
Changes in vaginal bacterial quantity (population) that colonize, called Community State Type (CST)	After 4-months	Changes in vaginal microbiota
Human papillomavirus (HPV) clearance	After 4-months	Testing negative for HPV