Clinical Investigation to Assess the Effect of Betaglucan... | NCT06987396

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

NCT06987396

Sponsor

Vitae Health Innovation

Status

Completed

Last Update Posted

May 23, 2025Actual

Enrollment

80Actual

Phase

Not Applicable

Conditions

Interventions

1000 mg Betaglucans (daily)

Countries

Spain

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

May 2025

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

May 15, 2023Actual

Primary Completion Date

May 15, 2025Actual

Completion Date

May 15, 2025Actual

First Submitted Date

May 15, 2025

First Submission Date that Met QC Criteria

May 22, 2025

First Posted Date

May 23, 2025Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

May 22, 2025

Last Update Posted Date

May 23, 2025Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

80Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Treated group with 1000 mg oral Betaglucans (Immunovita)	Experimental		Dietary Supplement: 1000 mg Betaglucans (daily)
Control group without treatment (active surveillance)	No Intervention

Interventions

Name	Type	Description	Arm Group Labels	Other Names
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)

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
RNA PCR Test result		From enrollment to the end of treatment at 6 months

Secondary Outcomes

Measure	Description	Time Frame
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

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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.

Accepts Healthy Volunteers

Sex

Female

Sex/Gender Based

Yes

Sex/Gender Description

Female

Minimum Age

30 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Facility	Status	City	State	ZIP	Country	Contacts
Gynaecology Department, Medical Service Ishtar		Barcelona		08034	Spain

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided