Efficacy and Safety of Carboxymethyl Beta-glucan and Policarbophil in HPV Positive Patients (Fix)

Uriach

Status: Completed

Conditions: Human Papillomavirus Infection

Treatments: Dietary Supplement: carboxymethyl β-glucan

Study type: Observational

Funder types: Industry

Identifiers

NCT06199128

The Fix Study V.2 12/Jul/2022

Details and patient eligibility

About

Prospective, Controlled, Multicentre, Real Clinical Practice Study. Effectiveness of Carboxymethyl β-Glucan treatment in high-risk HPV+ patients

Full description

To evaluate the effectiveness of local treatment with carboxymethyl-b-glucan and polycarbophil on the clearance time of human papillomavirus (HPV), as well as on the normalisation of cytological alterations identified at study inclusion.

Enrollment: 533 patients

Sex: Female

Ages: 25 to 65 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

TREATMENT GROUP

INCLUSION:

• Women aged between 25 and 65 years (inclusive).
• Histological cervical cytology results reported as ASCUS, LSIL/CIN1, with a positive cervical PCR determination for high-risk HPV (genotypes 16, 18, 31, 33, 35, 39, 45, 51, 52, 56, 58, 59, 66, and 68).
• Patients currently undergoing treatment with the combination of carboxymethyl B-glucan and polycarboxyl (for at least 15 days prior to study initiation)
• Capable of reading and comprehending the patient information sheet and the informed consent form.
• Willing to participate in the study and sign the informed consent form.

EXCLUSION:

• Cervical cytology indicating suspected invasive cervical cancer.
• Ongoing or recent pregnancy terminated within six weeks of the study commencement.
• Clinically significant immunodeficiency-linked pathology.
• Active or terminated immunosuppressive treatment within six months of study entry. Specifically, in the case of corticosteroids, women will be excluded if they are currently or recently receiving corticosteroid treatment (defined as within two weeks prior to study entry) or if they have undergone two or more cycles of corticosteroids at doses equal to or greater than 20 mg/day of Prednisone (or equivalent) orally or parenterally for at least one week's duration in the year prior to study entry.
• Undiagnosed abnormal genital bleeding.
• Total hysterectomy.
• Documented history of cervical pathology caused by HPV.
• Contraindications to the use of the combination of Carboxymethyl B-glucan and polycarboxyl, or known allergies to any of its components.

CONTROL GROUP

INCLUSION:

• Women aged between 25 and 65 years (inclusive).
• Histological cervical cytology results reported as ASCUS, LSIL/CIN1, with a positive cervical PCR determination for high-risk HPV (genotypes 16, 18, 31, 33, 35, 39, 45, 51, 52, 56, 58, 59, 66, and 68).
• Patients not currently undergoing treatment for HPV.
• Capable of reading and comprehending the patient information sheet and the informed consent form.
• Willing to participate in the study and sign the informed consent form.

EXCLUSION:

• Cervical cytology indicating suspected invasive cervical cancer.
• Ongoing or recent pregnancy terminated within six weeks of the study commencement.
• Clinically significant immunodeficiency-linked pathology.
• Active or terminated immunosuppressive treatment within six months of study entry. Specifically, in the case of corticosteroids, women will be excluded if they are currently or recently receiving corticosteroid treatment (defined as within two weeks prior to study entry) or if they have undergone two or more cycles of corticosteroids at doses equal to or greater than 20 mg/day of Prednisone (or equivalent) orally or parenterally for at least one week's duration in the year prior to study entry.
• Undiagnosed abnormal genital bleeding.
• Total hysterectomy.
• Documented history of cervical pathology caused by HPV.
• Concurrent participation in a clinical study of an investigational drug that could interfere with the current study.

Trial design

533 participants in 2 patient groups

CONTROL GROUP

Description:

For the duration of the study, standard clinical practice will be followed wait and see strategy, without administering carboxymethyl-b-glucan treatment.

TREATMENT GROUP

Description:

For a period of three months, patients will be administered once daily treatment with Carboxymethyl β-glucan and Polycarbophil

Treatment:

Dietary Supplement: carboxymethyl β-glucan