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

Launched by LIAQUAT UNIVERSITY OF MEDICAL & HEALTH SCIENCES · Feb 3, 2024

Keywords

ClinConnect Summary

This clinical trial is exploring whether a probiotic called Lactobacillus Crispatus-M247 (Crispact®) can help women clear high-risk types of human papillomavirus (HPV) infections, which are linked to cervical cancer. There is increasing interest in using probiotics as a potential therapy for this purpose, and researchers want to see if this specific probiotic can make a difference in HPV treatment.

To participate in this trial, women between the ages of 18 and 64 who have been identified as having low-grade or high-risk HPV (but do not require immediate treatment according to guidelines) may be eligible. Participants will need to understand the trial and provide written consent. The study is not yet recruiting, so interested individuals will have to wait for it to begin. If they join, they can expect to take the probiotic as part of the trial, and they will continue to be monitored with HPV testing over the study period. It's important to note that women who have been vaccinated for HPV, have had cervical treatments, or have certain health conditions will not be eligible for this study.

Gender

FEMALE

Eligibility criteria

• 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.