Efficacy of Lentinula Edodes-Derived Supplement (AHCC®) in Promoting Negativity of Persistent HPV Infection

Liaquat University of Medical & Health Sciences

Status: Completed

Conditions: HPV Infection

Treatments: Dietary Supplement: AHCC® (Active Hexose Correlated Compound); Biological: Gardasil 9®

Study type: Observational

Funder types: Other

Identifiers

NCT06752083

117_22.112024_Papion®

Details and patient eligibility

About

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.

Full 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.

Enrollment: 219 patients

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

219 participants in 3 patient groups

Unvaccinated with AHCC® Supplement

Description:

Participants receiving 3 capsules of AHCC® daily for 4-6 months. These participants were unvaccinated prior to the study and were treated with the dietary supplement to evaluate its impact on HPV negativity.

Treatment:

Dietary Supplement: AHCC® (Active Hexose Correlated Compound)

Vaccinated with AHCC® Supplement

Description:

Participants receiving both the Gardasil 9® vaccine and 3 capsules of AHCC® daily for 6 months. This group evaluates the combined impact of vaccination and dietary supplementation on HPV negativity.

Treatment:

Biological: Gardasil 9®

Dietary Supplement: AHCC® (Active Hexose Correlated Compound)

Vaccinated Only

Description:

Participants receiving only the Gardasil 9® vaccine without any AHCC® supplementation. This group serves as a comparator to evaluate the effects of the dietary supplement.

Treatment:

Biological: Gardasil 9®