Papillomavirus InfectionsNCT07755566
Effect of Oral Papilozumib on Vaginal and Intestinal Microbiota in Human Papillomavirus (HPV)-Positive Women
A study testing Papilozumib in people with Papillomavirus Infections, run by Hifas da Terra S.L. at 1 site in Spain.
Trial 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. Read more about this study
- Who is it for?
- Ages 30 to 65 years, women only
- Conditions the study is for
- Papillomavirus Infections
- What is being tested?
- Papilozumib
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 21 participants
- Where
- 1 siteSpain
- Study dates
- 5 May 2023to 30 May 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 30 to 65 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Show all 10Show fewer
- 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, pregnant, suspected pregnancy, or breastfeeding.
Trial locations and contacts
1 site in 1 country.
Spain1 site
Instituto Palacios, Salud y Medicina de la Mujer
Madrid, Madrid, 28009
About this study
Official title: Open-Label Clinical Trial to Evaluate the Effect of Papilozumib, an Oral Synbiotic Dietary Supplement, on Vaginal and Intestinal Microbiota in Human Papillomavirus (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.
Read the detailed description
Human papillomavirus (HPV) infection has been associated with changes in the vaginal microbiota. The intestinal microbiota may also influence immune responses through the gut-vagina axis and could therefore be relevant to the persistence or clearance of HPV infection.
This was an exploratory, open-label, single-group interventional study in women aged 30 to 65 years with a positive HPV polymerase chain reaction test and either normal cervical cytology or cytological findings classified as atypical squamous cells of undetermined significance (ASC-US), low-grade squamous intraepithelial lesion (LSIL), or atypical glandular cells (AGC).
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.
Vaginal and intestinal microbiota samples were collected at baseline and at Month 3. Microbiota composition was assessed using shotgun metagenomic sequencing to characterize the relative abundance and distribution of microbial taxa. Vaginal microbiota assessment included characterization of Lactobacillus-dominated community state types. Intestinal microbiota assessment included taxonomic composition and selected microbial functional genes.
Secondary assessments included HPV status by polymerase chain reaction, vaginal health measured using the Bachmann Vaginal Health Index (VHI), adverse events and tolerability, and adherence based on product-dispensing records. Safety evaluations included physical and gynecological examinations, vital signs, anthropometric measurements, and review of concomitant medications.
- Conditions
- Papillomavirus Infections
- Being tested
- Papilozumib
- Keywords
- Human Papillomavirus, Vaginal Microbiota, Intestinal Microbiota, Synbiotic Dietary Supplement, HPV Clearance, Gut-Vagina Axis, Vaginal Health Index
- Medical subject headings
- Papillomavirus Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PapilozumibDietary 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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Dietary Supplement: Papilozumib |
What is being measured
The primary outcome is the main question the study is designed to answer.
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 the characterization of Lactobacillus-dominated community state types.
Measured: 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 (Shannon index), and the abundance of 22 prespecified microbial functional genes.
Measured: Baseline and Month 3
Secondary outcomes (4)
Human papillomavirus (HPV) clearance at Month 3
Number and percentage of participants with a positive HPV polymerase chain reaction test at baseline who have a negative polymerase chain reaction test at Month 3.
Measured: Baseline and Month 3
Change in Bachmann Vaginal Health Index (VHI) score
Change from baseline in the Bachmann VHI total score. The index assesses vaginal elasticity, secretion type and consistency, vaginal pH, epithelial integrity, and moisture. Each component is rated on a 1-to-5 Likert scale, with higher scores indicating better vaginal health.
Measured: Baseline and Month 3
Number of participants with adverse events
Number and percentage of participants who experienced adverse events during treatment. Adverse events will be summarized by nature and severity to assess the dietary supplement's safety and tolerability.
Measured: From the first dose through Month 3
Treatment adherence based on dispensing records
Adherence to the prescribed regimen of three capsules daily, assessed using study product dispensing records.
Measured: From baseline through Month 3
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Aug 2026
- Study start5 May 2023
- Primary completion30 May 2024
- Study completion30 May 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Papillomavirus InfectionsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- 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.
- Masking
- None (open label)
- Enrolment
- 21 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hifas da Terra S.L.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Eurofins
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07755566
- Sponsor's protocol ID
- Hifas 2022-001
- Status last verified
- Aug 2026
- First submitted
- 5 Aug 2026
- Last updated
- 13 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: No individual participant data will be made available. The study protocol did not establish a prospective plan, repository, data dictionary, access criteria, or governance process for sharing participant-level data with external researchers. Study data will be maintained confidentially and handled in accordance with applicable data-protection requirements. Only aggregate, non-identifiable study results may be reported.
Study at a glance
From the registry record, last updated by the sponsor on 13 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Open-Label Clinical Trial to Evaluate the Effect of Papilozumib, an Oral Synbiotic Dietary Supplement, on Vaginal and Intestinal Microbiota in Human Papillomavirus (HPV)-Positive Women
- ClinicalTrials.gov ID
- NCT07755566
- Acronym / sponsor ID
- Hifas 2022-001
- Conditions
- Papillomavirus Infections
- Keywords
- Human Papillomavirus, Vaginal Microbiota, Intestinal Microbiota, Synbiotic Dietary Supplement, HPV Clearance, Gut-Vagina Axis, Vaginal Health Index
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 21 participants (actual)
- Lead sponsor
- Hifas da Terra S.L.Industry (pharma, biotech, devices)
- Collaborators
- Eurofins
- Study start
- 5 May 2023 (actual)
- Primary completion
- 30 May 2024 (actual)
- Study completion
- 30 May 2024 (actual)
- First posted
- 10 Aug 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Human papillomavirus (HPV) infection has been associated with changes in the vaginal microbiota. The intestinal microbiota may also influence immune responses through the gut-vagina axis and could therefore be relevant to the persistence or clearance of HPV infection.
This was an exploratory, open-label, single-group interventional study in women aged 30 to 65 years with a positive HPV polymerase chain reaction test and either normal cervical cytology or cytological findings classified as atypical squamous cells of undetermined significance (ASC-US), low-grade squamous intraepithelial lesion (LSIL), or atypical glandular cells (AGC).
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.
Vaginal and intestinal microbiota samples were collected at baseline and at Month 3. Microbiota composition was assessed using shotgun metagenomic sequencing to characterize the relative abundance and distribution of microbial taxa. Vaginal microbiota assessment included characterization of Lactobacillus-dominated community state types. Intestinal microbiota assessment included taxonomic composition and selected microbial functional genes.
Secondary assessments included HPV status by polymerase chain reaction, vaginal health measured using the Bachmann Vaginal Health Index (VHI), adverse events and tolerability, and adherence based on product-dispensing records. Safety evaluations included physical and gynecological examinations, vital signs, anthropometric measurements, and review of concomitant medications.
Study design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| Papilozumib | Experimental | Dietary Supplement: PapilozumibParticipants 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. |
Who may qualify
- Ages
- 30 to 65 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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.
Key exclusion criteria (10 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PapilozumibOral 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. | Dietary supplement | Papilozumib |
Primary outcome
Change in vaginal microbiota composition
Time frame: Baseline and Month 3
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 the characterization of Lactobacillus-dominated community state types.
Change in intestinal microbiota composition
Time frame: Baseline and Month 3
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 (Shannon index), and the abundance of 22 prespecified microbial functional genes.
4 secondary outcomes
Human papillomavirus (HPV) clearance at Month 3
Time frame: Baseline and Month 3
Change in Bachmann Vaginal Health Index (VHI) score
Time frame: Baseline and Month 3
Number of participants with adverse events
Time frame: From the first dose through Month 3
Treatment adherence based on dispensing records
Time frame: From baseline through Month 3
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Oct 2026.
- Individual participant dataSharing planned: No. No individual participant data will be made available. The study protocol did not establish a prospective plan, repository, data dictionary, access criteria, or governance process for sharing participant-level data with external researchers. Study data will be maintained confidentially and handled in accordance with applicable data-protection requirements. Only aggregate, non-identifiable study results may be reported.
Related trials for Papillomavirus Infections
Not yet recruitingPhase 1/2
Clinical Trial to Assess the Safety, Tolerability, Reactogenicity, and Immunogenicity of a 10 Valent Human Papillomavirus Virus (10vHPV) Vaccine
Human Papillomavirus Infection
Active, not recruitingPhase 4
Comparing Immune Response of 2 vs 3 HPV Doses (27-45 Years Old)
Immunization, HPV Infection
Not yet recruitingPhase 2
Combination Bevacizumab and PRGN-2012 in Adults With Recurrent Respiratory Papillomatosis (RRP)
Respiratory Recurrent Papillomatosis (RRP), Human Papillomavirus (HPV)
RecruitingPhase 2
A Study of the Preliminary Efficacy of DARE-HPV to Treat High-risk Persistent Human Papillomavirus (hrHPV)
Human Papilloma Virus (HPV), High-risk Human Papillomavirus Infection
RecruitingPhase 2
A Single Arm Phase II Trial in p16-positive Oropharynx Cancer of Selective Dose De-escalation of nodAl VolumEs at Minimal Risk and Primary Site Disease (SAVED)
Head and Neck Cancer, Head and Neck Squamous Cell Cancer
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Papilozumib in people with Papillomavirus Infections, run by Hifas da Terra S.L. at 1 site in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 13 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in vaginal microbiota composition (time frame: Baseline and Month 3). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Oct 2026.