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

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

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Human Papillomavirus Infection
• Intervention / Treatment: Dietary supplement: Placebo; Dietary supplement: Crispact®

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 Type: Interventional
• Enrollment (Estimated): 150
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Dr. Amjad Khan, DPhil; Phone Number: +92 333 05069552; Email: amjadkhan@lumhs.edu.pk
• Study Contact Backup: Name: Dr. Amjad Khan, DPhil

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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.	Dietary supplement: Crispact®; Contains 20 Bld CFU/Stick of probiotic Lactobacillus crispatus M247
Active Comparator: 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.	Dietary supplement: Placebo; Placebo
Experimental: 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.	Dietary supplement: Crispact®; Contains 20 Bld CFU/Stick of probiotic Lactobacillus crispatus M247
Active Comparator: 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.	Dietary supplement: Placebo; Placebo

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Liaquat University of Medical & Health Sciences
• Collaborators: Università degli Studi dell'Insubria

Study record dates

Study Major Dates

• Study Start (Estimated): February 10, 2024
• Primary Completion (Estimated): December 31, 2024
• Study Completion (Estimated): March 31, 2025

Study Registration Dates

• First Submitted: January 20, 2024
• First Submitted That Met QC Criteria: February 3, 2024
• First Posted (Estimated): February 7, 2024

Study Record Updates

• Last Update Posted (Estimated): February 7, 2024
• Last Update Submitted That Met QC Criteria: February 3, 2024
• Last Verified: February 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Virus Diseases; Infections; Communicable Diseases; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Disease Attributes; DNA Virus Infections; Tumor Virus Infections; Urogenital Diseases; Genital Diseases; Papillomavirus Infections
• Other Study ID Numbers: 774/18.10.2021

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No