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OpenTrials
Completed

NCT Number: NCT06987396

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

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.

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Key information

Conditions

HPV

Age range

30 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Gynaecology Department, Medical Service Ishtar

Barcelona, 08034, Spain

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

1000 mg Betaglucans (daily)

Dietary Supplement

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

Primary outcomes

  1. RNA PCR Test result

    Time frame: From enrollment to the end of treatment at 6 months

Secondary outcomes

  1. DNA PCR Test result

    Time frame: From enrollment to the end of treatment at 6 months

  2. Citology Test result

    Time frame: From enrollment to the end of treatment at 6 months

Sponsors and collaborators

Lead sponsor

Vitae Health Innovation

Industry

Registry information

Important dates

Study start
2023
Primary completion
2025
Study completion
2025
First posted
May 23, 2025
Registry last updated
May 23, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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