CompletedNot Applicable

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

Spain21 participantsStarted 2023-05-05

Plain-language 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.

Who can participate

Age range

30 Years – 65 Years

Sex

FEMALE

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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 vagi…

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Change in vaginal microbiota composition

Timeframe: Baseline and Month 3

Change in intestinal microbiota composition

Timeframe: Baseline and Month 3

Trial details

NCT IDNCT07755566

SponsorHifas da Terra S.L.

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2024-05-30

View on ClinicalTrials.gov More Papillomavirus Infections trials