Clinical Investigation to Assess the Effect of Betaglucan Administration in HPV Patients

Not Applicable

Completed

• Conditions: HPV

• Registration Number: NCT06987396
• Lead Sponsor: Vitae Health Innovation

Brief Summary

Randomised, controlled clinical study to assess the efficacy and tolerability of an oral supplementation of 1000 mg daily of Betaglucans in the evolution of patients with Human Papilloma Virus (HPV). The improvement is measured by DNA PCR test, cytology and a specific RNA test.

Detailed Description

Not available

Study Timeline

• Study Start: 2023-05-15
• Status Verified: 2025-05
• Primary Completion: 2025-05-15
• Study Completion: 2025-05-15
• Study First Submitted: 2025-05-15
• Study First Submitted QC: 2025-05-22
• Last Update Submitted: 2025-05-22
• Study First Posted: 2025-05-23
• Last Update Posted: 2025-05-23

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 80

Inclusion Criteria

• Women over 30 years old, whether or not they have been vaccinated against HPV
• Patients attending a visit with a routine cytological result of ASCUS or lSIL, or a normal result with a positive HPV test, no more than 3 months prior to be enrolled
• Patients who freely provide written informed consent
• Patients with a positive DNA PCR test

Exclusion Criteria

• Patients who are participating in another clinical study about the same or different condition within the 30 days prior to inclusion.
• Any subject who, in the investigator's opinion, is unable to follow instructions or properly comply with the treatment.
• Subjects who do not provide written informed consent to participate in the study.
• Patients who are receiving any of the prohibited drugs or supplements, and for whom withdrawal of these medications/products is expected to pose a significant issue.
• Pregnant or breastfeeding women.
• Transplanted patients and/or patients taking immunosuppressive medication.
• Patients with autoimmune diseases.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
RNA PCR Test result	From enrollment to the end of treatment at 6 months

Secondary Outcome Measures

Name	Time	Method
DNA PCR Test result	From enrollment to the end of treatment at 6 months
Citology Test result	From enrollment to the end of treatment at 6 months

Trial Locations

Locations (1)

Gynaecology Department, Medical Service Ishtar; 🇪🇸 Barcelona, Spain