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

NCT07755566 | Completed

• 1 other identifier: Hifas 2022-001
• Study Type: interventional
• Target: 21
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Papillomavirus Infections

Keywords

Human Papillomavirus; Vaginal Microbiota; Intestinal Microbiota; Synbiotic Dietary Supplement; HPV Clearance; Gut-Vagina Axis; Vaginal Health Index

Outcome Measures

Primary Outcomes (2)

• Change in vaginal microbiota composition

  Change from baseline in the composition of the vaginal microbiota, assessed by shotgun metagenomic sequencing. The assessment includes the relative abundance and distribution of vaginal microbial taxa and characterization of Lactobacillus-dominated community state types.

  Baseline and Month 3

• Change in intestinal microbiota composition

  Change from baseline in the composition of the intestinal microbiota, assessed by shotgun metagenomic sequencing. The assessment includes the relative abundance and distribution of intestinal microbial taxa, microbial diversity using the Shannon index, and the abundance of 22 prespecified microbial functional genes.

  Baseline and Month 3

Secondary Outcomes (4)

• HPV clearance at Month 3

  Baseline and Month 3

• Change in Bachmann Vaginal Health Index score

  Baseline and Month 3

• Number of participants with adverse events

  From the first dose through Month 3

• Treatment adherence based on dispensing records

  From baseline through Month 3

Study Arms (1)

Papilozumib

EXPERIMENTAL

Participants received Papilozumib, an oral synbiotic dietary supplement, for 3 months. The recommended daily dose was three capsules: two capsules in the morning while fasting and one capsule before the midday meal.

Dietary Supplement: Papilozumib

Interventions

Papilozumib DIETARY_SUPPLEMENT

Oral synbiotic dietary supplement containing extracts of Hericium erinaceus, Cordyceps sinensis, and Ganoderma lucidum, together with Saccharomyces cerevisiae, Lactobacillus rhamnosus, vitamins C, E, D3 and A, zinc, selenium, and acerola extract. Participants received three capsules daily for 3 months: two capsules in the morning while fasting and one capsule before the midday meal.

Papilozumib

Eligibility Criteria

• Age: 30 Years - 65 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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.
• 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.

Sponsors & Collaborators

• Hifas da Terra S.L.: lead
• Eurofins: collaborator

Study Sites (1)

Instituto Palacios, Salud y Medicina de la Mujer

Madrid, Madrid, 28009, Spain

Location

MeSH Terms

Conditions

Papillomavirus Infections

Condition Hierarchy (Ancestors)

Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Communicable Diseases; Infections; DNA Virus Infections; Virus Diseases; Tumor Virus Infections; Genital Diseases; Urogenital Diseases; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Single-group, open-label study in which all participants received the oral synbiotic dietary supplement for 3 months and were assessed at baseline and Month 3.

Study Record Dates

• First Submitted: August 5, 2026
• First Posted: August 10, 2026
• Study Start: May 5, 2023
• Primary Completion: May 30, 2024
• Study Completion: May 30, 2024
• Last Updated: August 10, 2026

Record last verified: 2026-08

Data Sharing

• IPD Sharing: Will not share

Locations

ES (1)