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

Liaquat University of Medical & Health Sciences

Status: Not yet enrolling

Conditions: Human Papillomavirus Infection

Treatments: Dietary Supplement: Placebo; Dietary Supplement: Crispact®

Study type: Interventional

Funder types: Other

Identifiers

NCT06245486

774/18.10.2021

Details and patient eligibility

About

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.

Full 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.

Enrollment: 150 estimated patients

Sex: Female

Ages: 18 to 64 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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150 participants in 4 patient groups

Probiotic Young Group (Women aged 18-29 years)

Experimental group

Description:

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.

Treatment:

Dietary Supplement: Crispact®

Control Young Group (Women aged 18-29 years)

Active Comparator group

Description:

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.

Treatment:

Dietary Supplement: Placebo

Probiotic Lady Group (Women aged 30-64 years)

Experimental group

Description:

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.

Treatment:

Dietary Supplement: Crispact®

Control Lady Group (Women aged 18-29 years)

Active Comparator group

Description:

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.

Treatment:

Dietary Supplement: Placebo