Upper Respiratory Tract Infection (URTI)NCT05598749
Poplar-type Propolis Dry Extract ESIT12 : Immunomodulation Efficacy Study
A study testing Verum in people with Upper Respiratory Tract Infection (URTI), run by Fytexia at 1 site in Spain.
Trial 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. Read more about this study
- Who is it for?
- Ages 25 to 69 yearsHealthy volunteers can take part
- Conditions the study is for
- Upper Respiratory Tract Infection (URTI)
- What is being tested?
- Verum
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 309 participants
- Where
- 1 siteSpain
- Study dates
- 5 Dec 2022to 3 Jul 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 25 to 69 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- inactive or minimally active according to the IPAQ short form questionnaire
- BMI 18,5-29,9
Who cannot join
- 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
Show all 18Show fewer
- 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)
Trial locations and contacts
1 site in 1 country.
About this 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)
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)
- Being tested
- Placebo, Verum
- Medical subject headings
- Respiratory Tract Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PlaceboDietary supplement
Arabic gum, sucrose and silicon dioxide mix
VerumDietary supplement
Propolis dry extract ESIT12 and carriers (arabic gum, sucrose and silicon dioxide mix)
| Study group | Role | What they receive |
|---|---|---|
| Placebo | Placebo comparator | Not described Receives: Dietary Supplement: Placebo |
| Verum | Experimental | Not described Receives: Dietary Supplement: Verum |
What is being measured
The primary outcome is the main question the study is designed to answer.
Supplementation Efficacy on URTI incidence
The incidence of URTI developped in Verum compare to Placebo measured with the WURSS-24 symptoms questionnaire
Measured: 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
Measured: 12 weeks
Secondary outcomes (4)
Supplementation Efficacy on URTI symptoms
The comparison of symptoms score (domain 2) between placebo and verum as measured with WURSS-24 questionnaire
Measured: 12 weeks
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
Measured: 12 weeks
Supplementation Efficacy on URTI severity
The comparison of global cold severity (domain 4) between placebo and verum as measured with WURSS-24 questionnaire
Measured: 12 weeks
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
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Oct 2022
- Study start5 Dec 2022
- Primary completion3 Jul 2024
- Study completion3 Jul 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Upper Respiratory Tract Infection (URTI)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 309 participants (actual)
Sponsor and investigators
- Lead sponsor
- Fytexia
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Pedro Alcaraz, Principal investigator, UCAM (Universidad Catolica San Antonio de Murcia)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05598749
- Sponsor's protocol ID
- ESIT12IES
- Status last verified
- Sep 2024
- First submitted
- 25 Oct 2022
- Last updated
- 25 Sep 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Sep 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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)
- ClinicalTrials.gov ID
- NCT05598749
- Acronym / sponsor ID
- ESIT12IES
- Conditions
- Upper Respiratory Tract Infection (URTI)
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 309 participants (actual)
- Lead sponsor
- FytexiaIndustry (pharma, biotech, devices)
- Study start
- 5 Dec 2022 (actual)
- Primary completion
- 3 Jul 2024 (actual)
- Study completion
- 3 Jul 2024 (actual)
- First posted
- 28 Oct 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Placebo | Placebo comparator | Dietary Supplement: Placebo |
| Verum | Experimental | Dietary Supplement: Verum |
Who may qualify
- Ages
- 25 to 69 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- inactive or minimally active according to the IPAQ short form questionnaire
- BMI 18,5-29,9
Key exclusion criteria (18 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PlaceboArabic gum, sucrose and silicon dioxide mix | Dietary supplement | Placebo |
| VerumPropolis dry extract ESIT12 and carriers (arabic gum, sucrose and silicon dioxide mix) | Dietary supplement | Verum |
Primary outcome
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
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
4 secondary outcomes
Supplementation Efficacy on URTI symptoms
Time frame: 12 weeks
Supplementation Efficacy on impact of URTI on quality of life
Time frame: 12 weeks
Supplementation Efficacy on URTI severity
Time frame: 12 weeks
Supplementation Efficacy on immunomodulation
Time frame: 12 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Sep 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Pedro Alcaraz principal investigator
UCAM (Universidad Catolica San Antonio de Murcia)
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Verum in people with Upper Respiratory Tract Infection (URTI), run by Fytexia at 1 site in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 18 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 25 Sep 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Supplementation Efficacy on URTI incidence (time frame: 12 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Sep 2024; AzTrials last refreshed its copy on 29 Oct 2026.