Poplar-type Propolis Dry Extract ESIT12 : Immunomodulation Efficacy Study

Last updated: September 23, 2024
Sponsor: Fytexia
Overall Status: Completed

Phase

N/A

Condition

Respiratory Syncytial Virus (Rsv) Infection

Treatment

Placebo

Verum

Clinical Study ID

NCT05598749
ESIT12IES
  • Ages 25-69
  • All Genders
  • Accepts Healthy Volunteers

Study 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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • inactive or minimally active according to the IPAQ short form questionnaire

  • BMI 18,5-29,9

Exclusion

Exclusion Criteria:

  • Pregnant women, breastfeeding women, women positive at Beta-HCG serology test andwho 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 priorto screening)

Study Design

Total Participants: 309
Treatment Group(s): 2
Primary Treatment: Placebo
Phase:
Study Start date:
December 05, 2022
Estimated Completion Date:
July 03, 2024

Connect with a study center

  • UCAM (Universidad Catolica San Antonio de Murcia)

    Murcia,
    Spain

    Site Not Available

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