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

NCT06245486 | Not Yet Recruiting DMC

• 1 other identifier: 774/18.10.2021
• Study Type: interventional
• Target: 150
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Human Papillomavirus Infection

Outcome Measures

Primary Outcomes (2)

• 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

Study Arms (4)

Probiotic Young Group (Women aged 18-29 years)

EXPERIMENTAL

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®

Control Young Group (Women aged 18-29 years)

ACTIVE COMPARATOR

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

Probiotic Lady Group (Women aged 30-64 years)

EXPERIMENTAL

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®

Control Lady Group (Women aged 18-29 years)

ACTIVE COMPARATOR

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

Interventions

Crispact® DIETARY_SUPPLEMENT

Contains 20 Bld CFU/Stick of probiotic Lactobacillus crispatus M247

Probiotic Lady Group (Women aged 30-64 years); Probiotic Young Group (Women aged 18-29 years)

Placebo DIETARY_SUPPLEMENT

Placebo

Control Lady Group (Women aged 18-29 years); Control Young Group (Women aged 18-29 years)

Eligibility Criteria

• Age: 18 Years - 64 Years
• Gender Eligibility Details: This study is only applicable in women
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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).

You may not qualify if:

• 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.

Sponsors & Collaborators

• Liaquat University of Medical & Health Sciences: lead
• Università degli Studi dell'Insubria: collaborator

MeSH Terms

Conditions

Papillomavirus Infections

Condition Hierarchy (Ancestors)

Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Communicable Diseases; Infections; DNA Virus Infections; Virus Diseases; Tumor Virus Infections; Genital Diseases; Urogenital Diseases; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Central Study Contacts

Dr. Amjad Khan, DPhil

CONTACT

+92 333 05069552; amjadkhan@lumhs.edu.pk

Dr. Amjad Khan, DPhil

CONTACT

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Clinical Biochemistry and Experimental Medicine

Model Details: Probiotic Crispact® (20 Bld CFU/Stick of Lactobacillus crispatus M247)

Study Record Dates

• First Submitted: January 20, 2024
• First Posted: February 7, 2024
• Study Start: February 10, 2024
• Primary Completion: December 31, 2024
• Study Completion: March 31, 2025
• Last Updated: February 7, 2024

Record last verified: 2024-02

Data Sharing

• IPD Sharing: Will not share