Poplar-type Propolis Dry Extract ESIT12 : Immunomodulation Efficacy Study

NCT05598749 | Completed

• 1 other identifier: ESIT12IES
• Study Type: interventional
• Target: 309
• Locations: 1 country
• Sites: 1

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.

Conditions

Upper Respiratory Tract Infection (URTI)

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (4)

• Supplementation Efficacy on URTI symptoms

  12 weeks

• Supplementation Efficacy on impact of URTI on quality of life

  12 weeks

• Supplementation Efficacy on URTI severity

  12 weeks

• Supplementation Efficacy on immunomodulation

  12 weeks

Study Arms (2)

Placebo

PLACEBO COMPARATOR

Dietary Supplement: Placebo

Verum

EXPERIMENTAL

Dietary Supplement: Verum

Interventions

Placebo DIETARY_SUPPLEMENT

Arabic gum, sucrose and silicon dioxide mix

Placebo

Verum DIETARY_SUPPLEMENT

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

Verum

Eligibility Criteria

• Age: 25 Years - 69 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• inactive or minimally active according to the IPAQ short form questionnaire
• BMI 18,5-29,9

You may not qualify if:

• 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

Sponsors & Collaborators

• Fytexia: lead

Study Sites (1)

UCAM (Universidad Catolica San Antonio de Murcia)

Murcia, Spain

Location

MeSH Terms

Conditions

Respiratory Tract Infections

Interventions

calcium D-pantothenate, L-cysteine drug combination

Condition Hierarchy (Ancestors)

Infections; Respiratory Tract Diseases

Study Officials

• Pedro Alcaraz

  UCAM (Universidad Catolica San Antonio de Murcia)

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 25, 2022
• First Posted: October 28, 2022
• Study Start: December 5, 2022
• Primary Completion: July 3, 2024
• Study Completion: July 3, 2024
• Last Updated: September 25, 2024

Record last verified: 2024-09

Data Sharing

• IPD Sharing: Will not share

Locations

ES (1)