Clinical trial · Observational
Efficacy of Lentinula Edodes-Derived Supplement (AHCC®) in Promoting Negativity of Persistent HPV Infection
Evaluation of the Efficacy and Safety of an AHCC®-Based Supplement (Lentinula Edodes) in Promoting Negativity of Persistent HPV Infection: A Retrospective Multicenter Clinical Study
NCT06752083CI-TRIAL-00101849completedClinicalTrials.gov clinicaltrialsProvenance
- 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 is a retrospective, multicenter, observational study evaluating real-world HPV-DNA clearance in women with documented persistent high-risk HPV infection lasting at least six months. Clinical data were retrospectively collected from medical records of women managed in routine practice with one of three strategies: AHCC® supplementation alone, nonavalent HPV vaccination alone, or the combination of AHCC® supplementation and nonavalent HPV vaccination. The primary objective is to assess HPV-DNA clearance at 4 and 6 months following treatment initiation.
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 |
|---|---|---|---|
| HPV Infection | — | UNRESOLVED | — |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| AHCC® (Active Hexose Correlated Compound) | Dietary Supplement | — | UNRESOLVED |
| Gardasil 9® | Biological | — | UNRESOLVED |
Design
Arms and outcomes
Arms (3)
- label
- Unvaccinated with AHCC® Supplement
- description
- Women previously managed in routine clinical practice with AHCC® supplementation alone for persistent HPV infection. Participants had not received HPV vaccination prior to treatment. Clinical data were retrospectively collected from medical records to evaluate HPV-DNA clearance following this real-world management strategy.
- interventionNames
- Dietary Supplement: AHCC® (Active Hexose Correlated Compound)
- label
- Vaccinated with AHCC® Supplement
- description
- Women previously managed in routine clinical practice with combined AHCC® supplementation and nonavalent HPV vaccination for persistent HPV infection. Treatments were prescribed as part of standard care. Clinical data were retrospectively collected to assess HPV-DNA clearance following combined real-world exposure.
- interventionNames
- Dietary Supplement: AHCC® (Active Hexose Correlated Compound)
- Biological: Gardasil 9®
- label
- Vaccinated Only
- description
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Female participants aged 18 years or older. * Documented persistent high-risk HPV infection for at least 6 continuous months, confirmed by consecutive HPV-DNA tests. * Absence of high-grade cervical lesions (≤ CIN1). * Availability of complete clinical records with evaluable HPV-DNA testing at baseline and follow-up. * Documented management with AHCC® supplementation alone, nonavalent HPV vaccination alone, or combined AHCC® supplementation and nonavalent HPV vaccination in routine clinical practice. * No prior excisional or ablative treatment of the cervix (including conization or LEEP). Exclusion Criteria: * History of cervical excisional or ablative treatment (including conization or LEEP). * Presence of high-grade cervical lesions (CIN2 or worse) or invasive cervical cancer. * Incomplete clinical documentation or missing HPV follow-up data. * Conditions known to significantly alter immune function, including ongoing immunosuppressive therapy, active autoimmune disease requiring systemic treatment, or documented immunodeficiency, when such information was available in medical records. * Prior systemic antiviral or immunomodulatory therapy specifically aimed at HPV clearance during the observation period.
References
Publications (3)
- BACKGROUNDGau VL, Benninger MS. Potential Role for Active Hexose Correlated Compound (AHCC) in Treatment of Recurrent Respiratory Papillomatosis. J Voice. 2022 Jul;36(4):441-442. doi: 10.1016/j.jvoice.2022.05.004. Epub 2022 Jun 27. No abstract available. PMID 35773058
- BACKGROUNDSmith JA, Mathew L, Gaikwad A, Rech B, Burney MN, Faro JP, Lucci JA 3rd, Bai Y, Olsen RJ, Byrd TT. From Bench to Bedside: Evaluation of AHCC Supplementation to Modulate the Host Immunity to Clear High-Risk Human Papillomavirus Infections. Front Oncol. 2019 Mar 20;9:173. doi: 10.3389/fonc.2019.00173. eCollection 2019. PMID 30949451
- BACKGROUNDSmith JA, Gaikwad AA, Mathew L, Rech B, Faro JP, Lucci JA 3rd, Bai Y, Olsen RJ, Byrd TT. AHCC(R) Supplementation to Support Immune Function to Clear Persistent Human Papillomavirus Infections. Front Oncol. 2022 Jun 22;12:881902. doi: 10.3389/fonc.2022.881902. eCollection 2022. PMID 35814366