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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

80 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-05-15

Study Completion Date

2025-05-15

Brief Summary

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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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Detailed Description

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Conditions

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HPV

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

RNA and DNA PCR tests were performed by a blinded external laboratory

Study Groups

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Treated group with 1000 mg oral Betaglucans (Immunovita)

Group Type EXPERIMENTAL

1000 mg Betaglucans (daily)

Intervention Type DIETARY_SUPPLEMENT

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

Control group without treatment (active surveillance)

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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1000 mg Betaglucans (daily)

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

Intervention Type DIETARY_SUPPLEMENT

Eligibility Criteria

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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.

Minimum Eligible Age

30 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No