Poplar-type Propolis Dry Extract ESIT12 : Immunomodulatio... | NCT05598749

Studies
Poplar-type Propolis Dry Extract ESIT12 : Immunomodulation Efficacy Study

NCT05598749

Sponsor

Fytexia

Status

Completed

Last Update Posted

Sep 25, 2024Actual

Enrollment

309Actual

Phase

Not Applicable

Conditions

Upper Respiratory Tract Infection (URTI)

Interventions

Placebo
Verum

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

Sep 2024

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

Dec 5, 2022Actual

Primary Completion Date

Jul 3, 2024Actual

Completion Date

Jul 3, 2024Actual

First Submitted Date

Oct 25, 2022

First Submission Date that Met QC Criteria

Oct 25, 2022

First Posted Date

Oct 28, 2022Actual

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

Sep 23, 2024

Last Update Posted Date

Sep 25, 2024Actual

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

FDAAA801 Violation

Not provided

Description Module

Brief Summary

The aim of the present investigation is to evaluate the immunomodulation effect of ESIT12, a poplar-type propolis dry extract standardized in polyphenols, and its efficacy in subjects at risk of contracting upper respiratory tract infections (URTIs), during a 12-week supplementation period plus 4-week follow-up.

The number of onset of upper respiratory tract infections, the symptoms severity and lasting and interferences with well-being will be assessed with WURSS-24 questionnaire. The quality of life will be assessed with the SF-36 questionnaire and a testimonial. Blood immune markers will also be assessed. Finally, long lasting benefits will additionally be evaluated 4 weeks after end of the supplementation period. The design of the study is double-blind, randomized, parallel and placebo controlled.

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

309Actual

Label	Type	Description	Intervention Names
Placebo	Placebo Comparator		Dietary Supplement: Placebo
Verum	Experimental		Dietary Supplement: Verum

Name	Type	Description	Arm Group Labels	Other Names
Placebo	Dietary Supplement	Arabic gum, sucrose and silicon dioxide mix	Placebo

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Supplementation Efficacy on URTI incidence	The incidence of URTI developped in Verum compare to Placebo measured with the WURSS-24 symptoms questionnaire	12 weeks
Supplementation Efficacy on number of URTI incidence	The number of URTI incidence per person in Verum compare to Placebo measured with the WURSS-24 symptoms questionnaire	12 weeks

Secondary Outcomes

Measure	Description	Time Frame
Supplementation Efficacy on URTI symptoms	The comparison of symptoms score (domain 2) between placebo and verum as measured with WURSS-24 questionnaire	12 weeks
Supplementation Efficacy on impact of URTI on quality of life

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

inactive or minimally active according to the IPAQ short form questionnaire
BMI 18,5-29,9

Exclusion Criteria:

Pregnant women, breastfeeding women, women positive at Beta-HCG serology test and who hope to become pregnant
Allergy to beehive products and known allergy (general)
Cystic fibrosis
Congenital or acquired immunodeficiency syndrome and disease
History of asthma (within prior 24 months) or chronic respiratory disease
Subjects who underwent medical treatment for COVID-19 within last 3 months
History of immune system disorder or auto-immune disorder
History of treated diabetes or treated hypertension
Evidence or history of hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, neurologic diseases, and malignancies
Cancers
Those considered unsuitable for the participation by the physician
No vaccination within 12 weeks prior to enrolling in the study
No antibiotics within 12 weeks prior to enrolling in the study
No anti-inflammatory drugs within 4 weeks prior to enrolling in the study
No steroids within 12 weeks prior to enrolling in the study
No immunological drugs within 4 weeks prior to enrolling in the study
No food/dietary supplements within 4 weeks prior to enrolling in the study
No current or recent participation in another clinical trial (within 30 days prior to screening)

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

25 Years

Maximum Age

69 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Name	Affiliation	Role
Pedro Alcaraz	UCAM (Universidad Catolica San Antonio de Murcia)	Principal Investigator

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

ID	Term
D007239	Infections
D012140	Respiratory Tract Diseases