Effect of Papilozumib Oral on Vaginal and Intestinal Microbiota in HPV-Positive Women

This open-label, single-group study evaluated the effects of a 3-month oral synbiotic dietary supplement on vaginal and intestinal microbiota in women with a positive human papillomavirus (HPV) test. Vaginal and intestinal microbiota were assessed at baseline and after 3 months of supplementation. Secondary assessments included HPV clearance, vaginal health, safety and tolerability, and treatment adherence.

Inclusion Criteria: * Female, aged 30 to 65 years, inclusive. * Able to read and understand the Participant Information Sheet and Informed Consent Form. * Willing to participate in the study and provide written informed consent. * Normal cervical cytology or cytological findings of atypical squamous cells of undetermined significance (ASC-US), low-grade squamous intraepithelial lesion (LSIL), or atypical glandular cells (AGC), confirmed no more than 3 months before the screening visit. * Positive human papillomavirus (HPV) polymerase chain reaction test performed at the screening visit or available from no more than 3 months before the baseline visit. * Able, in the investigator's judgment, to comply with the study requirements and follow the study instructions and assessments. Exclusion Criteria: * Clinically relevant immune system disorder, autoimmune disease, or current treatment with immunosuppressive agents. * Systemic or local antibiotic, antifungal, or other treatment capable of altering the microbiota within 4 weeks before study treatment initiation. * Undiagnosed abnormal genital bleeding within 6 months before the screening visit. * Symptomatic vulvovaginal infection. * Previous history of gynecological cancer. * Current participation in another clinical trial or participation in another clinical trial within 4 weeks before study inclusion. * Planned surgery that could prevent adherence to the study treatment regimen. * Use of vaginal contraceptives or other vaginal hormonal treatments. * Contraindication to the synbiotic dietary supplement or known allergy to any of its components. * Woman of childbearing potential not using effective contraception, pregnancy, suspected pregnancy, or breastfeeding.