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Trial Title:
Probiotc Lactobacillus Crispatus-M247 (Crispact®) Supplementation in the Sterilization of High-risk Human Papilloma (HPV-HR) Viruses
NCT ID:
NCT06245486
Condition:
Human Papillomavirus Infection
Conditions: Official terms:
Papillomavirus Infections
Study type:
Interventional
Study phase:
N/A
Overall status:
Not yet recruiting
Study design:
Allocation:
Randomized
Intervention model:
Parallel Assignment
Intervention model description:
Probiotic Crispact® (20 Bld CFU/Stick of Lactobacillus crispatus M247)
Primary purpose:
Treatment
Masking:
Single (Investigator)
Intervention:
Intervention type:
Dietary Supplement
Intervention name:
Crispact®
Description:
Contains 20 Bld CFU/Stick of probiotic Lactobacillus crispatus M247
Arm group label:
Probiotic Lady Group (Women aged 30-64 years)
Arm group label:
Probiotic Young Group (Women aged 18-29 years)
Intervention type:
Dietary Supplement
Intervention name:
Placebo
Description:
Placebo
Arm group label:
Control Lady Group (Women aged 18-29 years)
Arm group label:
Control Young Group (Women aged 18-29 years)
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.
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.
Criteria for 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.
Gender:
Female
Gender based:
Yes
Gender description:
This study is only applicable in women
Minimum age:
18 Years
Maximum age:
64 Years
Healthy volunteers:
No
Start date:
February 10, 2024
Completion date:
March 31, 2025
Lead sponsor:
Agency:
Liaquat University of Medical & Health Sciences
Agency class:
Other
Collaborator:
Agency:
Università degli Studi dell'Insubria
Agency class:
Other
Source:
Liaquat University of Medical & Health Sciences
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06245486
