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

NCT06987396 | Completed

• 1 other identifier: VITAE HEALTH INNOVATION S.L.
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

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.

Conditions

HPV

Keywords

HPV; Betaglucans; Immunity; RNA

Outcome Measures

Primary Outcomes (1)

• RNA PCR Test result

  From enrollment to the end of treatment at 6 months

Secondary Outcomes (2)

• 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

Study Arms (2)

Treated group with 1000 mg oral Betaglucans (Immunovita)

EXPERIMENTAL

Dietary Supplement: 1000 mg Betaglucans (daily)

Control group without treatment (active surveillance)

NO INTERVENTION

Interventions

1000 mg Betaglucans (daily) DIETARY_SUPPLEMENT

Patients in the experimental group receive betaglucans supplement in capsule form, administered orally

Treated group with 1000 mg oral Betaglucans (Immunovita)

Eligibility Criteria

• Age: 30 Years+
• Gender Eligibility Details: Female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Vitae Health Innovation: lead

Study Sites (1)

Gynaecology Department, Medical Service Ishtar

Barcelona, 08034, Spain

Location

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: RNA and DNA PCR tests were performed by a blinded external laboratory
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 15, 2025
• First Posted: May 23, 2025
• Study Start: May 15, 2023
• Primary Completion: May 15, 2025
• Study Completion: May 15, 2025
• Last Updated: May 23, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will not share

Locations

ES (1)