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

Completed · Not applicable

Conditions studied: Papillomavirus Infections

In brief

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.

Key facts

Study ID

NCT07755566

Run by

Hifas da Terra S.L.

People needed

21

Starts

2023-05-05

Expected to finish

2024-05-30

Last updated by the study team

2026-08-10

Who can join

Age: 30 and older, up to 65. Sex: female. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• Instituto Palacios, Salud y Medicina de la Mujer — Madrid, Madrid, Spain

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.