Human Papillomavirus Infection
Conditions
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.
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.
Interventions
DIETARY_SUPPLEMENTCrispact®
Contains 20 Bld CFU/Stick of probiotic Lactobacillus crispatus M247
DIETARY_SUPPLEMENTPlacebo
Placebo
Sponsors
Università degli Studi dell'Insubria
Liaquat University of Medical & Health Sciences
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Investigator)
Intervention model description
Probiotic Crispact® (20 Bld CFU/Stick of Lactobacillus crispatus M247)
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 64 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Changes in vaginal bacterial quantity (population) that colonize, called Community State Type (CST) | After 4-months | Changes in vaginal microbiota |
| Human papillomavirus (HPV) clearance | After 4-months | Testing negative for HPV |
Contacts
Primary ContactDr. Amjad Khan, DPhil
Backup ContactDr. Amjad Khan, DPhil
Outcome results
None listed