An interventional study of Papilozumib in Papillomavirus Infections, sponsored by Hifas da Terra S.L.. Completed at 1 site in Spain. Open to female participants aged 30 Years to 65 Years. Per ClinicalTrials.gov, last updated 2026-10-13.
Sponsored by Hifas da Terra S.L. · Not applicable, Interventional, and Basic science
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.
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.
576 studies on the registry are indexed under Papillomavirus Infections; 132 are open to participants now.
This study's enrollment of 21 is below the median of 235 across 402 interventional studies indexed under Papillomavirus Infections.
Browse Papillomavirus Infections studies →Hifas da Terra S.L. is the lead sponsor of 5 studies on the registry; 1 is open to participants now.
Counted across the registry records on this site, refreshed daily.
The criteria were revised on the registry on Oct 13, 2026. See what changed
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
A condition in which the immune system attacks the body’s own tissues, such as rheumatoid arthritis, lupus, psoriasis, type 1 diabetes or inflammatory bowel disease.
Immunotherapy studies often leave out active autoimmune disease, and some name exceptions, such as thyroid disease on replacement hormone. Check the exceptions this study lists.
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Clinically significant
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Autoimmune disease
A condition in which the immune system attacks the body’s own tissues, such as rheumatoid arthritis, lupus, psoriasis, type 1 diabetes or inflammatory bowel disease.
Immunotherapy studies often leave out active autoimmune disease, and some name exceptions, such as thyroid disease on replacement hormone. Check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Immunosuppression
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraception
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Childbearing potential
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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
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.
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.
Time frame: 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.
Time frame: Baseline and Month 3
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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: From baseline through Month 3
Plan to share: 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.
No publications or documents are linked to this record.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
This study is completed, as verified in Aug 2026. You cannot join it, but the record below documents what was studied.
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