Poplar-type Propolis Dry Extract ESIT12 : Immunomodulation Efficacy Study

Study Overview
=================
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.

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)

Conditions
-----------------
Upper Respiratory Tract Infection (URTI)

Intervention / Treatment
-----------------
* Dietary Supplement: Placebo
* Dietary Supplement: Verum


Participation Criteria
=================
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)

Ages Eligible for Study
-----------------
Minimum Age: 25 Years
Maximum Age: 69 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: Placebo<br> | Dietary Supplement: Placebo<br>* Arabic gum, sucrose and silicon dioxide mix<br>|
| Experimental: Verum<br> | Dietary Supplement: Verum<br>* Propolis dry extract ESIT12 and carriers (arabic gum, sucrose and silicon dioxide mix)<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | 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 Outcome Measures

| Outcome Measure | 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 | The comparison of cold-specific functional impairments (domain 3) between placebo and verum as measured with WURSS-24 questionnaire | 12 weeks | 
| Supplementation Efficacy on URTI severity | The comparison of global cold severity (domain 4) between placebo and verum as measured with WURSS-24 questionnaire | 12 weeks | 
| 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 | 12 weeks |