Papillomavirus Infections
Conditions
Keywords
Human Papillomavirus, Vaginal Microbiota, Intestinal Microbiota, Synbiotic Dietary Supplement, HPV Clearance, Gut-Vagina Axis, Vaginal Health Index
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.
Detailed description
Human papillomavirus 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, 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.
Interventions
DIETARY_SUPPLEMENTPapilozumib
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.
Sponsors
Hifas da Terra S.L.
Eurofins
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
BASIC_SCIENCE
Masking
NONE
Intervention 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.
Eligibility
Sex/Gender
FEMALE
Age
30 Years to 65 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in vaginal microbiota composition | 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 characterization of Lactobacillus-dominated community state types. |
| Change in intestinal microbiota composition | 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 using the Shannon index, and the abundance of 22 prespecified microbial functional genes. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| HPV clearance at Month 3 | Baseline and Month 3 | Number and percentage of participants with a positive human papillomavirus polymerase chain reaction test at baseline who have a negative polymerase chain reaction test at Month 3. |
| Change in Bachmann Vaginal Health Index score | Baseline and Month 3 | Change from baseline in the Bachmann Vaginal Health Index 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. |
| Number of participants with adverse events | From the first dose through Month 3 | Number and percentage of participants who experience adverse events during the treatment period. Adverse events will be summarized according to their nature and severity to assess the safety and tolerability of the dietary supplement. |
| Treatment adherence based on dispensing records | From baseline through Month 3 | Adherence to the prescribed regimen of three capsules daily, assessed using study product dispensing records. |
Countries
Spain
Outcome results
None listed