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Poplar-type Propolis Dry Extract ESIT12 : Immunomodulation Efficacy Study

Primary Purpose

Upper Respiratory Tract Infection (URTI)

Status

Recruiting

Phase

Not Applicable

Locations

Spain

Study Type

Interventional

Intervention

Placebo

Verum

About this trial

This is an interventional prevention trial for Upper Respiratory Tract Infection (URTI)

Eligibility Criteria

25 Years - 69 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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)

Sites / Locations

UCAM (Universidad Catolica San Antonio de Murcia)Recruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Placebo Comparator

Experimental

Arm Label

Placebo

Verum

Arm Description

Outcomes

Primary Outcome Measures

Supplementation Efficacy on URTI incidence

The incidence of URTI developped in Verum compare to Placebo measured with the WURSS-24 symptoms questionnaire

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

Secondary Outcome Measures

Supplementation Efficacy on URTI symptoms

The comparison of symptoms score (domain 2) between placebo and verum as measured with WURSS-24 questionnaire

Supplementation Efficacy on impact of URTI on quality of life

The comparison of cold-specific functional impairments (domain 3) between placebo and verum as measured with WURSS-24 questionnaire

Supplementation Efficacy on URTI severity

The comparison of global cold severity (domain 4) between placebo and verum as measured with WURSS-24 questionnaire

Supplementation Efficacy on immunomodulation

Assessment of immunological vigor (SIV) as monitored by 4 PBMC panels Panel 1 : global activation Panel 2 : Tcells focus Panel 3 : B cells focus Panel : Neutrophils / monocytes focus

Full Information

NCT ID

NCT05598749

First Posted

October 25, 2022

Last Updated

February 17, 2023

Sponsor

Fytexia

1. Study Identification

Unique Protocol Identification Number

NCT05598749

Brief Title

Poplar-type Propolis Dry Extract ESIT12 : Immunomodulation Efficacy Study

Official Title

Evaluation of the Immunomodulation Effect of ESIT12, a Poplar-type Propolis Dry Extract and Its Efficacy in Subjects at Risk of Contracting Upper Respiratory Tract Infections (URTIs)

Study Type

Interventional

2. Study Status

Record Verification Date

February 2023

Overall Recruitment Status

Recruiting

Study Start Date

December 5, 2022 (Actual)

Primary Completion Date

May 31, 2024 (Anticipated)

Study Completion Date

June 30, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Fytexia

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Upper Respiratory Tract Infection (URTI)

7. Study Design

Primary Purpose

Prevention

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

ParticipantCare ProviderInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

350 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Placebo

Arm Type

Placebo Comparator

Arm Title

Verum

Arm Type

Experimental

Intervention Type

Dietary Supplement

Intervention Name(s)

Placebo

Intervention Description

Arabic gum, sucrose and silicon dioxide mix

Intervention Type

Dietary Supplement

Intervention Name(s)

Verum

Intervention Description

Propolis dry extract ESIT12 and carriers (arabic gum, sucrose and silicon dioxide mix)

Primary Outcome Measure Information:

Title

Supplementation Efficacy on URTI incidence

Description

The incidence of URTI developped in Verum compare to Placebo measured with the WURSS-24 symptoms questionnaire

Time Frame

12 weeks

Title

Supplementation Efficacy on number of URTI incidence

Description

The number of URTI incidence per person in Verum compare to Placebo measured with the WURSS-24 symptoms questionnaire

Time Frame

12 weeks

Secondary Outcome Measure Information:

Title

Supplementation Efficacy on URTI symptoms

Description

The comparison of symptoms score (domain 2) between placebo and verum as measured with WURSS-24 questionnaire

Time Frame

12 weeks

Title

Supplementation Efficacy on impact of URTI on quality of life

Description

The comparison of cold-specific functional impairments (domain 3) between placebo and verum as measured with WURSS-24 questionnaire

Time Frame

12 weeks

Title

Supplementation Efficacy on URTI severity

Description

The comparison of global cold severity (domain 4) between placebo and verum as measured with WURSS-24 questionnaire

Time Frame

12 weeks

Title

Supplementation Efficacy on immunomodulation

Description

Assessment of immunological vigor (SIV) as monitored by 4 PBMC panels Panel 1 : global activation Panel 2 : Tcells focus Panel 3 : B cells focus Panel : Neutrophils / monocytes focus

Time Frame

12 weeks

10. Eligibility

Sex

All

Minimum Age & Unit of Time

25 Years

Maximum Age & Unit of Time

69 Years

Accepts Healthy Volunteers

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)

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Julien Cases

Phone

+33 467 219 098

jcases@fytexia.com

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Pedro Alcaraz

Organizational Affiliation

UCAM (Universidad Catolica San Antonio de Murcia)

Official's Role

Principal Investigator

Facility Information:

Facility Name

UCAM (Universidad Catolica San Antonio de Murcia)

City

Murcia

Country

Spain

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Linda Chung

12. IPD Sharing Statement

Plan to Share IPD

Learn more about this trial

Poplar-type Propolis Dry Extract ESIT12 : Immunomodulation Efficacy Study

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