Clinical trial NCT06752083: Efficacy of Lentinula Edodes-Derived Supplement (AHCC®) in Promoting Negativity of Persistent HPV Infection
Official title: 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
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: HPV Infection
Lead sponsor: Liaquat University of Medical & Health Sciences
Sponsor class: OTHER
Collaborators: name: Università degli Studi dell'Insubria
First posted: 2024-12-30
Enrollment: 219
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Women with confirmed persistent HPV infection for more than 6 months, recruited from multiple clinical centers, who meet the inclusion criteria and consent to participate in the study.

Brief summary: This retrospective, multicenter clinical study evaluates the efficacy and safety of an AHCC®-based supplement derived from Lentinula edodes in promoting the negativity of persistent HPV infection lasting more than six months. The study involves three groups: unvaccinated participants receiving AHCC®, vaccinated participants receiving both AHCC® and the HPV vaccine, and vaccinated participants receiving only the HPV vaccine.

Detailed description: The study investigates the ability of AHCC® (Active Hexose Correlated Compound) to support immune modulation and promote negativity of persistent HPV infections, which are associated with an increased risk of cervical cancer. Participants are categorized into three groups based on vaccination and supplement use. Outcomes include the proportion of participants achieving HPV negativity and the safety and tolerability of the supplement over a 4-6 month period. The study aims to evaluate the potential of AHCC® as a complementary approach for managing persistent HPV infection.

Eligibility criteria: Inclusion Criteria:

* Female participants aged 18 years or older.
* Persistent HPV infection for at least 6 continuous months, confirmed by DNA-HPV testing.
* No prior treatment for cervical lesions via conization.
* No prior HPV vaccination

Exclusion Criteria:

* Current or planned pregnancy during the study period.
* Immunocompromised status, including known HIV infection.
* Severe or high-grade cervical lesions.
* Known allergy or hypersensitivity to AHCC® or vaccine components.

Primary outcomes:
measure: HPV Negativity Rate
timeFrame: 6 months
Secondary outcomes:
measure: Incidence of Treatment-Related Adverse Events
timeFrame: 6 months
Other outcomes:
Locations:
city: Varese
country: Italy
facility: University of Insubria
Study officials:
References:
citation: Gau 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.
citation: Smith 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.
citation: Smith 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.