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
Sponsored by
About this trial
This is an interventional prevention trial for Upper Respiratory Tract Infection (URTI)
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)
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
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
No
Studies a U.S. FDA-regulated Device Product
No
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
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
Email
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
No
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Poplar-type Propolis Dry Extract ESIT12 : Immunomodulation Efficacy Study
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