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

Completed

• Conditions: HPV Infection
• Interventions: Dietary Supplement: AHCC® (Active Hexose Correlated Compound); Biological: Gardasil 9®

• Registration Number: NCT06752083
• Lead Sponsor: Liaquat University of Medical & Health Sciences

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.

Study Timeline

• Study Start: 2023-01-02
• Primary Completion: 2024-06-30
• Status Verified: 2024-12
• Study Completion: 2024-12-15
• Study First Submitted: 2024-12-20
• Study First Submitted QC: 2024-12-27
• Last Update Submitted: 2024-12-27
• Study First Posted: 2024-12-30
• Last Update Posted: 2024-12-30

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 219

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Unvaccinated with AHCC® Supplement	AHCC® (Active Hexose Correlated Compound)	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.
Vaccinated with AHCC® Supplement	AHCC® (Active Hexose Correlated Compound)	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.
Vaccinated with AHCC® Supplement	Gardasil 9®	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.
Vaccinated Only	Gardasil 9®	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.

Primary Outcome Measures

Name	Time	Method
HPV Negativity Rate	6 months	Proportion of participants achieving HPV infection negativity as determined by DNA-HPV testing.

Secondary Outcome Measures

Name	Time	Method
Incidence of Treatment-Related Adverse Events	6 months	Record the number of treatment-related adverse events (TEAEs) related to the intervention.

Trial Locations

Locations (1)

University of Insubria; 🇮🇹 Varese, Italy