Poplar-type Propolis Dry Extract ESIT12 : Immunomodulation Efficacy Study

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)

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.

Study Overview

• Status: Recruiting
• Conditions: Upper Respiratory Tract Infection (URTI)
• Intervention / Treatment: Dietary supplement: Placebo; Dietary supplement: Verum

• Study Type: Interventional
• Enrollment (Estimated): 350
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Julien Cases; Phone Number: +33 467 219 098; Email: jcases@fytexia.com

Study Locations

• Spain
  • Murcia, Spain
    • Recruiting
    • UCAM (Universidad Catolica San Antonio de Murcia)
    • Contact: Linda Chung

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 25 years to 69 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

Description

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)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Placebo	Dietary supplement: Placebo; Arabic gum, sucrose and silicon dioxide mix
Experimental: Verum	Dietary supplement: Verum; Propolis dry extract ESIT12 and carriers (arabic gum, sucrose and silicon dioxide mix)

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

Collaborators and Investigators

• Sponsor: Fytexia
• Investigators: Principal Investigator: Pedro Alcaraz, UCAM (Universidad Catolica San Antonio de Murcia)

Study record dates

Study Major Dates

• Study Start (Actual): December 5, 2022
• Primary Completion (Estimated): June 30, 2024
• Study Completion (Estimated): July 30, 2024

Study Registration Dates

• First Submitted: October 25, 2022
• First Submitted That Met QC Criteria: October 25, 2022
• First Posted (Actual): October 28, 2022

Study Record Updates

• Last Update Posted (Estimated): February 26, 2024
• Last Update Submitted That Met QC Criteria: February 23, 2024
• Last Verified: February 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Infections; Respiratory Tract Infections
• Other Study ID Numbers: ESIT12IES

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No