Poplar-type Propolis Dry Extract ESIT12 : Immunomodulation Efficacy Study

• Sponsor: Fytexia (Industry)
• Overall Status: Not yet recruiting
• CT.gov ID: NCT05598749
• Collaborator: (none)
• Enrollment: 350
• Arms: 2
• Anticipated Duration (Months): 8

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Upper Respiratory Tract Infection (URTI)	Dietary Supplement: Placebo; Dietary Supplement: Verum	N/A

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 350 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
• Primary Purpose: Prevention
• 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)
• Anticipated Study Start Date: Oct 31, 2022
• Anticipated Primary Completion Date: Jun 30, 2023
• Anticipated Study Completion Date: Jun 30, 2023

Arms and Interventions

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)

Outcome Measures

Primary Outcome Measures

1. Supplementation Efficacy on URTI incidence [12 weeks]

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

2. Supplementation Efficacy on number of URTI incidence [12 weeks]

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

Secondary Outcome Measures

1. Supplementation Efficacy on URTI symptoms [12 weeks]

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

2. Supplementation Efficacy on impact of URTI on quality of life [12 weeks]

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

3. Supplementation Efficacy on URTI severity [12 weeks]

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

4. Supplementation Efficacy on immunomodulation [12 weeks]

   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

Eligibility Criteria

Criteria

• Ages Eligible for Study: 25 Years to 69 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

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)

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

• Fytexia

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Fytexia
• ClinicalTrials.gov Identifier: NCT05598749
• Other Study ID Numbers: ESIT12IES
• First Posted: Oct 28, 2022
• Last Update Posted: Nov 7, 2022
• Last Verified: Nov 1, 2022

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Infections; Respiratory Tract Infections

Study Results

No Results Posted as of Nov 7, 2022