Condition category
Respiratory
Date applied
21/03/2020
Date assigned
27/03/2020
Last edited
05/08/2020
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Background and study aim
The effects of cold and flu on the mouth, throat, and windpipe (upper respiratory tract infections) are very common and are one of the most frequent causes of the doctor's consultation.
Propolis (also known as bee resin) is the generic name used to identify a natural, resinous substance collected by bees (Apis mellifera) from buds and exudates of different plant species consisting of resin (50%), waxes (30%), essential oils (10%), pollen (5%), and other compounds including minerals and organic compounds. Propolis exerts a number of biological properties such as anti-inflammatory and antimicrobial activity. Propolis also has an effect on the respiratory system, as such, it can significantly reduce the number and nocturnal asthma attacks severity. It is able to improve lung function and reduce inflammation defence mechanisms. European propolis hydroalcoholic extract with a high content of polyphenols will be used in the present clinical study to treat mild upper respiratory tract infection.

Who can participate?
Individuals affected by the first symptoms of mild uncomplicated upper respiratory tract infections, aged 18 - 77 years old (updated 05/08/2020, previously: 18 - 65 years old.)

What does the study involve?
Participants are randomly allocated into two experimental groups: placebo and propolis. Treatment: administration (2-4 times/day) of propolis or placebo spray for five days.
Participants will be assessed at day three and day five and referred to further treatment if their condition requires it. After 15 days there will be a final assessment.

What are the possible benefits and risks of participating?
Participants taking part in this study should have a benefit on the first symptoms of mild uncomplicated upper respiratory tract infections, including a reduction in the incidence of drug treatment and a reduction in the incidence of the emergence of antibiotic-resistant pathogenic strains. There are no known risks to participants taking part in this study, considering the traditional use of propolis for the maintenance of the oral cavity and upper respiratory tract health.

Where is the study run from?
U.C.C.P (Center for primary care), Benevento (Italy)

When is the study starting and how long is it expected to run for?
December 2019 to January 2020

Who is funding the study?
B Natural (Italy)

Who is the main contact?
Prof. Maria Daglia (scientific), maria.daglia@unina.it
Dr Cristina Esposito (public), cristina.esposito@unina.it

Trial website

Contact information

Type

Scientific

Primary contact

Prof Maria Daglia

ORCID ID

http://orcid.org/0000-0002-4870-7713

Contact details

Università degli Studi di Napoli Federico II
Domenico Montesano street
49
Naples
80131
Italy
+39 3331703492
maria.daglia@unina.it

Type

Public

Additional contact

Dr Cristina Esposito

ORCID ID

Contact details

Università degli Studi di Napoli Federico II
Domenico Montesano street
49
Naples
80131
Italy
+39 (0)81678644
cristina.esposito@unina.it

Additional identifiers

EudraCT number

Nil known

ClinicalTrials.gov number

Nil known

Protocol/serial number

PROURTI0119

Study information

Scientific title

Study of the effect of European propolis hydro-alcoholic extract chemically characterized with high polyphenols content (SPRAY PROPOLIS URTI) on the first symptoms of mild uncomplicated upper respiratory tract infections: a double-blinded, placebo-controlled, parallel-group, single-center study

Acronym

DPRO

Study hypothesis

The clinical study purpose is to test the propolis extract capacity:
1. To reduce the first common symptoms occurring during mild uncomplicated URTIs and therefore the pharmacological treatment incidence (use of anti-inflammatory and/or antibiotic and/or antitussive drugs)
2. To reduce antibiotic-resistant pathogenic strains incidence at the end of the follow-up, in the subjects in which URTIs is caused by bacteria

Ethics approval

Approved 18/12/2019, ASL Benevento Ethics Committee (Via Oderisio, n1, 82100, Benevento, Italy; +39 (0)824308419; comitatoetico@aslbenevento1.it), ref: 152869

Study design

Interventional double-blind placebo-controlled randomized parallel single-centre trial

Primary study design

Interventional

Secondary study design

Randomised parallel trial

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

Not available in web format, please use the contact details below to request a patient information sheet

Condition

Uncomplicated mild upper respiratory tract infections

Intervention

Participants are randomly allocated into two experimental groups: placebo and propolis.

t0 (i.e. before the treatment start). Patients with symptoms reflecting a mild uncomplicated upper respiratory tract infection which meet the inclusion criteria are examined for the symptom assessment. The patient is expected to perform the oropharyngeal swab (followed by antibiogram if positive).

Treatment: administration (2-4 times/day) of propolis oral spray or placebo spray for 5 days.

If after 3 days of treatment with propolis or placebo at t1 (3 days after the follow-up visit) fever appears the patient has to be submitted to a visit to evaluate the type of therapeutic treatment to be administered.

If after 5 days of treatment with propolis or placebo at t2 (after 5 days from the start of treatment ie at the end of the treatment) the symptoms and/or fever appears the patient has to be submitted to a visit to evaluate the type of therapeutic treatment administered (the subject is excluded from the clinical trial).

Follow up: t3 monitoring (15 days after the end of propolis or placebo treatment).

The randomization sequence will be generated by a statistician using STATA 16 software (Stata Statistical Software: Release 16. College Station, TX: StataCorp LLC), and subjects (compliant to the inclusion and exclusion criteria) will be assigned to each of the two treatment groups (propoli and placebo) randomly and unpredictably by simple randomization (1:1 allocation ratio). The randomization code will consist of a three-digit number as indicated in the respective Case Report Form (CRF).

Intervention type

Supplement

Phase

Drug names

Primary outcome measure

The presence of sore throat, muffled dysphonia and swelling and redness of throat measured by the physician at baseline (t0), t1(after 3 days), t2 (after 5 days)

Secondary outcome measures

Bacteria susceptibility test performed at t0 (enrollment time) and t3 (after 15 days).

The Kirby-Bauer method was used to determine susceptibility to antibiotics of the bacteria occurring in the biological material taken from throat swab. The medium used is Mueller-Hinton agar. To prepare the inoculum, 4-5 colonies grown on the primary isolation medium, are suspended in 4-5 ml of Tryptic Soy Broth (enrichment broth), incubating for 2-6 hours.
1. A bacterial suspension adjusted at 0,5 MacFarland standard (see Clinical Laboratory Standards Institute document) is inoculated with a sterile swab on MH agar surface.
2. Antimicrobial-impregnated disks were placed on agar surface, using a sterile tweezers.
3. Plates were incubated at 37°C for 24 hours.
4. Tests were evaluated by diameter alone inhibition around disks.
Reading an antibiogram:
Resistant bacterium: 1 - 9 mm halo
Bacterium with intermediate resistance: 10 - 18 mm halo
Sensitive bacterium: 19 - 30 mm halo

Overall trial start date

02/09/2019

Overall trial end date

20/01/2020

Reason abandoned (if study stopped)

Eligibility

Participant inclusion criteria

Current inclusion criteria as of 05/08/2020:
1. Aged 18 - 77 years of age
2. Affected by the first symptoms of mild uncomplicated upper respiratory tract infections

Previous inclusion criteria:
1. Aged 18 - 65 years of age
2. Affected by the first symptoms of mild uncomplicated upper respiratory tract infections

Participant type

Healthy volunteer

Age group

Adult

Gender

Both

Target number of participants

122

Participant exclusion criteria

1. Individuals with allergies, which could be confused with those with irritation upper airway, object of study
2. Immunocompromised subjects
3. Subjects under immunological therapy
4. Subjects who received antibiotic therapy within 72 hours prior to enrollment
5. Pregnant women
6. Breastfeeding women
7. All patients with overt malignant neoplasia, recent cardio-cerebro-vascular diseases (within 90 days prior to enrollment), with severe middle renal; insufficiency (ascertained with creatinine clearance), and non-autonomous
8. All subjects who according to the doctors are not eligible to participate in the study in question

Recruitment start date

19/12/2019

Recruitment end date

31/12/2019

Locations

Countries of recruitment

Italy

Trial participating centre

UCCP (Center for primary care)
Via Manzoni, 19
San Giorgio del Sannio
82100
Italy

Sponsor information

Organisation

B Natural

Sponsor details

Via Gran Sasso
33
Corbetta (MI)
20011
Italy
+39 (0)249470332
bnatural@bnatural.it

Sponsor type

Industry

Website

https://bnatural.it/

Funders

Funder type

Industry

Funder name

B Natural

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Planned publication in a high-impact peer-review journal.

IPD sharing statement:
Data of individual patients will be available upon request of patient permission.

Intention to publish date

15/04/2020

Participant level data

Available on request

Basic results (scientific)

Publication list

Publication citations

Additional files

Editorial Notes

05/08/2020: The following changes were made to the trial record: 1. The inclusion criteria were changed. 2. The plain English summary was updated to reflect these changes. 27/03/2020: Uploaded protocol (not peer reviewed) as an additional file. 26/03/2020: Trial’s existence confirmed by Università degli Studi di Napoli Federico II.