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

Human Papillomavirus Infection Clinical Trial

Official title:

Study on the Efficacy of Crispact® (Probiotic Containing Lactobacillus Crispatus M247) in the Sterilization of HPV-HR and in the Reconstitution of the Normal Vaginal Microbiota

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06245486
• Other study ID #: 774/18.10.2021
• Status: Not yet recruiting
• Phase: N/A
• Start date: February 10, 2024
• Est. completion date: March 31, 2025

Study information

• Verified date: February 2024
• Source: Liaquat University of Medical & Health Sciences
• Contact: Dr. Amjad Khan, DPhil
• Phone: +92 333 05069552
• Email: amjadkhan[@]lumhs.edu.pk
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 150
• Est. completion date: March 31, 2025
• Est. primary completion date: December 31, 2024
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 64 Years

Eligibility

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.

Related Conditions & MeSH terms

• Human Papillomavirus Infection
• Papillomavirus Infections

Intervention

Dietary Supplement:
• Crispact®
Contains 20 Bld CFU/Stick of probiotic Lactobacillus crispatus M247
• Placebo
Placebo

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
Liaquat University of Medical & Health Sciences	Università degli Studi dell'Insubria

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Human papillomavirus (HPV) clearance	Testing negative for HPV	After 4-months
Primary	Changes in vaginal bacterial quantity (population) that colonize, called Community State Type (CST)	Changes in vaginal microbiota	After 4-months