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NCT Number: NCT05598749

Poplar-type Propolis Dry Extract ESIT12 : Immunomodulation Efficacy Study

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.

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Key information

Conditions

Upper Respiratory Tract Infection (URTI) Infections Respiratory Tract Diseases Respiratory Tract Infections

Age range

25 year–69 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

UCAM (Universidad Catolica San Antonio de Murcia)

Murcia, Spain

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Placebo

Dietary Supplement

Arabic gum, sucrose and silicon dioxide mix

Verum

Dietary Supplement

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

Primary outcomes

  1. Supplementation Efficacy on URTI incidence

    Time frame: 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

    Time frame: 12 weeks

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

Secondary outcomes

  1. Supplementation Efficacy on URTI symptoms

    Time frame: 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

    Time frame: 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

    Time frame: 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

    Time frame: 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

Sponsors and collaborators

Lead sponsor

Fytexia

Industry

Registry information

Official study 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)

Important dates

Study start
2022
Primary completion
2024
Study completion
2024
First posted
Oct 28, 2022
Registry last updated
Sep 25, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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