Clinical trial · Interventional
Effect of Papilozumib Oral on Vaginal and Intestinal Microbiota in HPV-Positive Women
Open-Label Clinical Trial to Evaluate the Effect of the Mico HPV Synbiotic Dietary Supplement on Vaginal and Intestinal Microbiota in HPV-Positive Patients
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Papillomavirus Infections | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Papilozumib | Dietary Supplement | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Papilozumib
- description
- 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.
- interventionNames
- Dietary Supplement: Papilozumib
Primary outcomes (2)
- measure
- Change in vaginal microbiota composition
- timeFrame
- Baseline and Month 3
- description
- 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.
- measure
- Change in intestinal microbiota composition
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 30 Years
- Maximum age
- 65 Years
Show eligibility criteria text
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.
References
Publications (0)
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