Efficacy of Probiotic Lactobacillus Crispatus M247 in Promoting High-risk Human Papillomavirus (HR-HPV) Infection Clearance and Modifying Vaginal Microbiota

Liaquat University of Medical & Health Sciences

Status: Completed

Conditions: Human Papillomavirus Infection

Treatments: Dietary Supplement: Lactobacillus crispatus M247 (Crispact®); Other: Placebo

Study type: Interventional

Funder types: Other

Identifiers

NCT06802809

Protocol n° 774/18.10.2021/AK

Details and patient eligibility

About

This clinical trial evaluates the efficacy of the probiotic strain Lactobacillus crispatus M247 in promoting the clearance of genital high-risk human papillomavirus (HR-HPV) infection and restoring the balance of the vaginal microbiota. The study adopts a multicenter, randomized, single-blind, longitudinal, prospective design involving HR-HPV-positive patients. Primary outcomes include HR-HPV clearance rates and microbiota composition changes.

Full description

This study investigates the potential benefits of Lactobacillus crispatus M247, a probiotic strain with proven ability to promote vaginal health, in the management of HR-HPV infections. Lactobacillus crispatus M247 has demonstrated superior probiotic properties, including the ability to produce lactic acid and hydrogen peroxide, which contribute to maintaining a stable vaginal microbiota and potentially inhibiting HR-HPV persistence.

Participants will be randomized to receive either Lactobacillus crispatus M247 or a placebo over a specified study period. The primary aim is to evaluate the probiotic's efficacy in enhancing HR-HPV clearance rates and restoring a balanced vaginal microbiota. Secondary objectives include assessing changes in cervical cytology and participant-reported outcomes on vaginal health. By focusing exclusively on the role of Lactobacillus crispatus M247, the study seeks to establish its clinical relevance in HR-HPV management and its potential as a therapeutic intervention.

Enrollment: 66 patients

Sex: Female

Ages: 18 to 69 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Women aged 18-69 years.
• First diagnosis of HR-HPV infection via DNA-HPV screening.
• Cytology results showing ASC-US or LSIL.
• Negative colposcopy or biopsy (absence of lesions).
• Ability to provide written informed consent.

Exclusion criteria

• Prior HPV vaccination.
• History of cervical treatments for pre-neoplastic pathology.
• Cytology showing HSIL (High-Grade Squamous Intraepithelial Lesion) requiring treatment.
• Current treatment with antibiotics, immunomodulatory, or immunosuppressive therapies.
• Diagnosed immune system or neoplastic diseases requiring chemotherapy.
• Pregnancy, lactation, or planning to become pregnant within 6 months.
• Known hypersensitivity to product components.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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66 participants in 2 patient groups, including a placebo group

Probiotic supplement Lactobacillus crispatus M247 group

Experimental group

Description:

Participants in this group will receive probiotic supplement Lactobacillus crispatus M247 (Crispact®) in stick form, administered orally at a dose of one stick per day for 4 months. Each stick contains 20 billion CFU of L. crispatus M247.

Treatment:

Dietary Supplement: Lactobacillus crispatus M247 (Crispact®)

Control Group

Placebo Comparator group

Description:

Participants in the control group will receive a placebo identical in appearance and packaging to the experimental product, administered orally at a dose of one stick per day for 4 months.

Treatment:

Other: Placebo