Human Papillomavirus InfectionFixNCT06199128
Efficacy and Safety of Carboxymethyl Beta-glucan and Policarbophil in HPV Positive Patients
An observational study of Human Papillomavirus Infection, run by Uriach Consumer Healthcare at 5 sites in Spain.
Trial summary
Prospective, Controlled, Multicentre, Real Clinical Practice Study. Effectiveness of Carboxymethyl β-Glucan treatment in high-risk HPV+ patients Read more about this study
- Who is it for?
- Ages 25 to 65 years, women only
- Conditions the study is for
- Human Papillomavirus Infection
- What is being tested?
- carboxymethyl β-glucan
- How many people
- 533 participants
- Where
- 5 sitesSpain
- Study dates
- 22 Sep 2022to 22 Nov 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 25 to 65 years
- Women only
- No healthy volunteers
- Adult, Older adult
Study population: The data will be collected from patients who meet the selection criteria.
Who may be able to join
- 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.
- Women aged between 25 and 65 years (inclusive).
Show all 10Show fewer
- 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.
Who cannot join
- 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.
Show all 17Show fewer
- 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
- 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 locations and contacts
5 sites in 1 country.
5 sites in 1 country
Spain5 sites
Hospital CIMA, Barcelona
Barcelona
Hospital Quirón San José
Madrid, 28002
Hospital Universitario Infanta Leonor,
Madrid, 28031
Hospital Universitario Infanta Leonor
Madrid, 28031
Hospital Quirón Donostia
San Sebastián, 20012
About this study
Official title: Evaluation of the Efficacy and Safety of the Local Treatment of Carboxymethyl Beta-glucan and Polycarbophil in Patients With Normal Cytology/ASCUS/LSIL (CIN1) With HPV+ PCR Determination
Prospective, Controlled, Multicentre, Real Clinical Practice Study. Effectiveness of Carboxymethyl β-Glucan treatment in high-risk HPV+ patients
Read the detailed 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.
- Conditions
- Human Papillomavirus Infection
- Being tested
- carboxymethyl β-glucan
- Keywords
- HPV
- Medical subject headings
- Papillomavirus Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
carboxymethyl β-glucanDietary supplement
It is a vaginal spray gel designed for the prevention and treatment of cervical lesions caused by HPV. This is achieved by controlling the physiological conditions of the transformation zone of the cervico-vaginal mucosa. The composition of the gel, which includes polycarbophil and carboxymethyl-beta-glucan, effectively shields the cervico-vaginal mucosa from the damaging effects of external agents due to its bioadhesive capacity. Additionally, it contributes to the re-epithelialization and regression of cervical lesions
| Study group | Role | What they receive |
|---|---|---|
| CONTROL GROUP | For the duration of the study, standard clinical practice will be followed wait and see strategy, without administering carboxymethyl-b-glucan treatment. | |
| TREATMENT GROUP | For a period of three months, patients will be administered once daily treatment with Carboxymethyl β-glucan and Polycarbophil Receives: Dietary Supplement: carboxymethyl β-glucan |
What is being measured
The primary outcome is the main question the study is designed to answer.
Evolution in the total or partial negativization of high-risk HPV infection in women with or without cytological alterations upon local treatment with carboxymethyl-β-glucan and polycarbophil.
Evaluation of the total or partial negativization of HPV by HPV PCR test with genotype
Measured: 6 months
Secondary outcomes (3)
Normalization rate of abnormal colposcopy
Evaluation of abnormal or normal colposcopy
Measured: 6 Months
Change in the incidence of cytological alterations upon local treatment with carboxymethyl - β-glucan and polycarbophil during the follow-up time
Change in the incidence of cytological alterations development measured by reflex cytology test (Normal Cytology; ASCUS; LSIL or HSIL cytology)
Measured: 6 Months
Determine the effect of local treatment with carboxymethyl - β-glucan and polycarbophil on the total negativization rate of HPV
Evaluation of HPV total negativization rate by HPV PCR test with genotype
Measured: 6 Months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jan 2024
- Study start22 Sep 2022
- Primary completion22 Sep 2023
- Study completion22 Nov 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Human Papillomavirus InfectionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 533 participants (actual)
Sponsor and investigators
- Lead sponsor
- Uriach Consumer Healthcare
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Carmen Pingarrón Santofima, Doctor, Principal investigator, Hospital Quirón San José
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06199128
- Sponsor's protocol ID
- The Fix Study V.2 12/Jul/2022
- Acronym
- Fix
- Status last verified
- Dec 2023
- First submitted
- 18 Dec 2023
- Last updated
- 10 Jan 2024
- Results posted
- No
- Data monitoring committee
- No
Publications
Stentella P, Biamonti A, Carraro C, Inghirami P, Mancino P, Pietrangeli D, Votano S, Lazzari P, DE Medici C. Efficacy of carboxymethyl beta-glucan in cervical intraepithelial neoplasia: a retrospective, case-control study. Minerva Ginecol. 2017 Oct;69(5):425-430. doi: 10.23736/S0026-4784.17.04053-9.
PubMed 28675291Chaichian S, Moazzami B, Sadoughi F, Haddad Kashani H, Zaroudi M, Asemi Z. Functional activities of beta-glucans in the prevention or treatment of cervical cancer. J Ovarian Res. 2020 Mar 5;13(1):24. doi: 10.1186/s13048-020-00626-7.
PubMed 32138756Pietrantoni E, Signore F, Berardi G, Donadio F, Donadio C. [Role of beta-glucan in the treatment of recurrent candidiasis and HPV-correlated lesions and reparative process of epidermis]. Minerva Ginecol. 2010 Feb;62(1):1-5. Italian.
PubMed 20186110Lavitola G, Della Corte L, De Rosa N, Nappi C, Bifulco G. Effects on Vaginal Microbiota Restoration and Cervical Epithelialization in Positive HPV Patients Undergoing Vaginal Treatment with Carboxy-Methyl-Beta-Glucan. Biomed Res Int. 2020 Apr 27;2020:5476389. doi: 10.1155/2020/5476389. eCollection 2020.
PubMed 32420349Laccetta G, Carrone A, Burratti M, Mancino P. Effect of the treatment with beta-glucan in women with cervical cytologic report of atypical squamous cells of undetermined significance (ASCUS) and low-grade squamous intraepithelial lesions (L-SIL). Minerva Ginecol. 2015 Apr;67(2):113-20. Epub 2015 Feb 5.
PubMed 25668505Jentschke M, Lehmann R, Drews N, Hansel A, Schmitz M, Hillemanns P. Psychological distress in cervical cancer screening: results from a German online survey. Arch Gynecol Obstet. 2020 Sep;302(3):699-705. doi: 10.1007/s00404-020-05661-9. Epub 2020 Jun 27.
PubMed 32594298
Study at a glance
From the registry record, last updated by the sponsor on 10 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Efficacy and Safety of the Local Treatment of Carboxymethyl Beta-glucan and Polycarbophil in Patients With Normal Cytology/ASCUS/LSIL (CIN1) With HPV+ PCR Determination
- ClinicalTrials.gov ID
- NCT06199128
- Acronym / sponsor ID
- Fix / The Fix Study V.2 12/Jul/2022
- Conditions
- Human Papillomavirus Infection
- Keywords
- HPV
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 533 participants (actual)
- Lead sponsor
- Uriach Consumer HealthcareIndustry (pharma, biotech, devices)
- Study start
- 22 Sep 2022 (actual)
- Primary completion
- 22 Sep 2023 (actual)
- Study completion
- 22 Nov 2023 (actual)
- First posted
- 10 Jan 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Prospective, Controlled, Multicentre, Real Clinical Practice Study. Effectiveness of Carboxymethyl β-Glucan treatment in high-risk HPV+ patients
Detailed 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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| CONTROL GROUP | – | –For the duration of the study, standard clinical practice will be followed wait and see strategy, without administering carboxymethyl-b-glucan treatment. |
| TREATMENT GROUP | – | Dietary Supplement: carboxymethyl β-glucanFor a period of three months, patients will be administered once daily treatment with Carboxymethyl β-glucan and Polycarbophil |
Who may qualify
- Ages
- 25 to 65 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The data will be collected from patients who meet the selection criteria.
Key inclusion criteria (10 listed)
- 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.
Key exclusion criteria (17 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| carboxymethyl β-glucanIt is a vaginal spray gel designed for the prevention and treatment of cervical lesions caused by HPV. This is achieved by controlling the physiological conditions of the transformation zone of the cervico-vaginal mucosa. The composition of the gel, which includes polycarbophil and carboxymethyl-beta-glucan, effectively shields the cervico-vaginal mucosa from the damaging effects of external agents due to its bioadhesive capacity. Additionally, it contributes to the re-epithelialization and regression of cervical lesions | Dietary supplement | TREATMENT GROUP |
Primary outcome
Evolution in the total or partial negativization of high-risk HPV infection in women with or without cytological alterations upon local treatment with carboxymethyl-β-glucan and polycarbophil.
Time frame: 6 months
Evaluation of the total or partial negativization of HPV by HPV PCR test with genotype
3 secondary outcomes
Normalization rate of abnormal colposcopy
Time frame: 6 Months
Change in the incidence of cytological alterations upon local treatment with carboxymethyl - β-glucan and polycarbophil during the follow-up time
Time frame: 6 Months
Determine the effect of local treatment with carboxymethyl - β-glucan and polycarbophil on the total negativization rate of HPV
Time frame: 6 Months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Jan 2024.
- Background: PubMed 28675291Stentella P, Biamonti A, Carraro C, Inghirami P, Mancino P, Pietrangeli D, Votano S, Lazzari P, DE Medici C. Efficacy of carboxymethyl beta-glucan in cervical intraepithelial neoplasia: a retrospective, case-control study. Minerva Ginecol. 2017 Oct;69(5):425-430. doi: 10.23736/S0026-4784.17.04053-9.
- Background: PubMed 32138756Chaichian S, Moazzami B, Sadoughi F, Haddad Kashani H, Zaroudi M, Asemi Z. Functional activities of beta-glucans in the prevention or treatment of cervical cancer. J Ovarian Res. 2020 Mar 5;13(1):24. doi: 10.1186/s13048-020-00626-7.
- Background: PubMed 20186110Pietrantoni E, Signore F, Berardi G, Donadio F, Donadio C. [Role of beta-glucan in the treatment of recurrent candidiasis and HPV-correlated lesions and reparative process of epidermis]. Minerva Ginecol. 2010 Feb;62(1):1-5. Italian.
- Background: PubMed 32420349Lavitola G, Della Corte L, De Rosa N, Nappi C, Bifulco G. Effects on Vaginal Microbiota Restoration and Cervical Epithelialization in Positive HPV Patients Undergoing Vaginal Treatment with Carboxy-Methyl-Beta-Glucan. Biomed Res Int. 2020 Apr 27;2020:5476389. doi: 10.1155/2020/5476389. eCollection 2020.
- Background: PubMed 25668505Laccetta G, Carrone A, Burratti M, Mancino P. Effect of the treatment with beta-glucan in women with cervical cytologic report of atypical squamous cells of undetermined significance (ASCUS) and low-grade squamous intraepithelial lesions (L-SIL). Minerva Ginecol. 2015 Apr;67(2):113-20. Epub 2015 Feb 5.
- Background: PubMed 32594298Jentschke M, Lehmann R, Drews N, Hansel A, Schmitz M, Hillemanns P. Psychological distress in cervical cancer screening: results from a German online survey. Arch Gynecol Obstet. 2020 Sep;302(3):699-705. doi: 10.1007/s00404-020-05661-9. Epub 2020 Jun 27.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Carmen Pingarrón Santofima, Doctor principal investigator
Hospital Quirón San José
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Human Papillomavirus Infection, run by Uriach Consumer Healthcare at 5 sites in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 17 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 10 Jan 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Evolution in the total or partial negativization of high-risk HPV infection in women with or without cytological alterations upon local treatment with carboxymethyl-β-glucan and polycarbophil. (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06199128, which also lists 6 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Jan 2024.