Rhinitis AcuteNCT06758804

Efficacy of Winterized Pistacia Lentiscus Oil in Reducing Purulent Bacterial Overinfection of Pediatric Rhinitis

A study testing Winterized Pistacia Lentiscus Oil Nasal Drops (Bactorinol®) and Saline Solution (0.9% NaCl) in people with Rhinitis Acute, run by Liaquat University of Medical & Health Sciences at 1 site in Italy.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

This study aims to evaluate the efficacy and safety of a medical device containing winterized Pistacia lentiscus oil in reducing symptoms of purulent bacterial overinfection in pediatric rhinitis and the need for antibiotic therapy. Read more about this study

Who is it for?: Ages 2 to 10 years
Conditions the study is for: Rhinitis Acute
What is being tested?: Winterized Pistacia Lentiscus Oil Nasal Drops (Bactorinol®) and Saline Solution (0.9% NaCl)
Type of treatment: Medical device
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 105 participants
Where: 1 siteItaly
Study dates: 2 Jan 2025to 15 Jun 2025
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 2 to 10 years
All sexes
No healthy volunteers
Child

Who may be able to join

Children aged 2 to 10 years.
Clinical symptoms of dense mucosal rhinitis/purulent mucus.
Onset of symptoms ≤ 5 days before enrollment.

Who cannot join

Onset of symptoms > 5 days before enrollment.
Presence of neurological, malformative, or immunological pathology.
Suspected or confirmed allergy to the active substance.
Use of antibiotics within 48 hours prior to enrollment.

Trial locations and contacts

1 site in 1 country.

Italy1 site

Università degli Studi dell'Insubria
Varese

Other trials in Italy

About this study

Official title: Evaluation of the Efficacy of Winterized Pistacia Lentiscus Oil in Reducing Purulent Bacterial Overinfection of Pediatric Rhinitis: A Multicenter Randomized Controlled Trial

Read the detailed description

This is a prospective, multicenter, randomized controlled trial to assess the therapeutic potential of winterized Pistacia lentiscus oil (WLO) in pediatric patients aged 2 to 10 years with purulent rhinitis. The study will investigate the reduction of rhinitis symptoms, the need for antibiotics, and secondary outcomes including nasal decongestant activity and treatment safety.

Participants will be randomized into two groups: the intervention group will receive 3 drops of WLO per nostril, three times daily for six days, while the control group will use 0.9% saline solution under the same regimen. Clinical evaluations will be conducted by medical staff and parents over six days to record symptom improvement, antibiotic use, and adverse events. The results will contribute to understanding the potential of WLO as a non-antibiotic treatment option for purulent bacterial overinfection in pediatric rhinitis.

Conditions: Rhinitis Acute
Being tested: Winterized Pistacia Lentiscus Oil Nasal Drops (Bactorinol®), Saline Solution (0.9% NaCl)
Medical subject headings: Common Cold

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Winterized Pistacia Lentiscus Oil Nasal Drops (Bactorinol®)Device
Participants will receive winterized Pistacia lentiscus oil nasal drops (Bactorinol®), administered as 3 drops per nostril, three times daily for six consecutive days.
Saline Solution (0.9% NaCl)Device
Participants will receive a saline solution (0.9% NaCl) administered as 3 drops per nostril, three times daily for six consecutive days.

Study groups in NCT06758804
Study group	Role	What they receive
Winterized Pistacia Lentiscus Oil Drops	Experimental	Not described Receives: Device: Winterized Pistacia Lentiscus Oil Nasal Drops (Bactorinol®)
Saline Placebo Drops	Placebo comparator	Not described Receives: Device: Saline Solution (0.9% NaCl)

What is being measured

The primary outcome is the main question the study is designed to answer.

Change in Purulent Rhinitis Symptoms
Evaluate the change in symptoms of purulent rhinitis, such as nasal congestion and mucosal discharge, in the experimental group compared to the control group.
Measured: 6 days

Secondary outcomes (3)

Change in Antibiotic Use
Measure the percentage of participants experiencing a change in antibiotic therapy requirements in the experimental group compared to the control group.
Measured: 6 days
Change in nasal obstruction
Change in the nasal obstruction measured via a 10-point Visual Analog Scale.
Measured: 6 days
Incidence of Treatment-Emergent Adverse Events
Record the number and type of treatment-emergent adverse events (TEAEs) related to the use of the intervention.
Measured: 6 days

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

2 Jan 202515 Jun 2025

First posted6 Jan 2025
Study start2 Jan 2025
Primary completion3 Jun 2025
Study completion15 Jun 2025

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (3)Papers the sponsor has linked to this study.
Other trials for Rhinitis AcuteStudies 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: Supportive care
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Enrolment: 105 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT06758804
Sponsor's protocol ID: 116_22.11.2024_BACTORINOL_Siti
Status last verified: Jun 2025
First submitted: 20 Dec 2024
Last updated: 29 Jun 2025
Results posted: No
Data monitoring committee: Yes
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No

Publications

Arroll B, Kenealy T. Are antibiotics effective for acute purulent rhinitis? Systematic review and meta-analysis of placebo controlled randomised trials. BMJ. 2006 Aug 5;333(7562):279. doi: 10.1136/bmj.38891.681215.AE. Epub 2006 Jul 21.
PubMed 16861253
Orru G, Demontis C, Mameli A, Tuveri E, Coni P, Pichiri G, Coghe F, Rosa A, Rossi P, D'hallewin G. The Selective Interaction of Pistacia lentiscus Oil vs. Human Streptococci, an Old Functional Food Revisited with New Tools. Front Microbiol. 2017 Oct 24;8:2067. doi: 10.3389/fmicb.2017.02067. eCollection 2017.
PubMed 29114245
Di Pierro F, Sagheddu V, Galletti S, Forti M, Elli M, Bertuccioli A, Gaeta S. Antibacterial Activity of a Fractionated Pistacia lentiscus Oil Against Pharyngeal and Ear Pathogens, Alone or in Combination With Antibiotics. Front Microbiol. 2021 Jun 17;12:686942. doi: 10.3389/fmicb.2021.686942. eCollection 2021.
PubMed 34220777

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Effect of Immune X on Common Cold Incidence in Healthy Adults
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Not yet recruitingPhase 3
A Study to Evaluate DEP114 for the Treatment of Acute Exacerbation of Persistent Allergic Rhinitis in Children Aged 6 to Under 12 Years
Persistent Allergic Rhinitis

All Rhinitis Acute trials

Study at a glance

From the registry record, last updated by the sponsor on 29 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Evaluation of the Efficacy of Winterized Pistacia Lentiscus Oil in Reducing Purulent Bacterial Overinfection of Pediatric Rhinitis: A Multicenter Randomized Controlled Trial
ClinicalTrials.gov ID: NCT06758804
Acronym / sponsor ID: 116_22.11.2024_BACTORINOL_Siti
Conditions: Rhinitis Acute
Study type: Interventional
Recruitment status: Completed
Enrolment: 105 participants (actual)
Lead sponsor: Liaquat University of Medical & Health SciencesUniversity, hospital or other
Collaborators: Università degli Studi dell'Insubria
Study start: 2 Jan 2025 (actual)
Primary completion: 3 Jun 2025 (actual)
Study completion: 15 Jun 2025 (actual)
First posted: 6 Jan 2025 (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.

Detailed description

Study design

Primary purpose: Supportive care
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 2

Arm	Type	Receives
Winterized Pistacia Lentiscus Oil Drops	Experimental	Device: Winterized Pistacia Lentiscus Oil Nasal Drops (Bactorinol®)
Saline Placebo Drops	Placebo comparator	Device: Saline Solution (0.9% NaCl)

Who may qualify

Ages: 2 to 10 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Child

Key inclusion criteria (3 listed)

Children aged 2 to 10 years.
Clinical symptoms of dense mucosal rhinitis/purulent mucus.
Onset of symptoms ≤ 5 days before enrollment.

Key exclusion criteria (4 listed)

Onset of symptoms > 5 days before enrollment.
Presence of neurological, malformative, or immunological pathology.
Suspected or confirmed allergy to the active substance.
Use of antibiotics within 48 hours prior to enrollment.

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
Winterized Pistacia Lentiscus Oil Nasal Drops (Bactorinol®)Participants will receive winterized Pistacia lentiscus oil nasal drops (Bactorinol®), administered as 3 drops per nostril, three times daily for six consecutive days.	Device	Winterized Pistacia Lentiscus Oil Drops
Saline Solution (0.9% NaCl)Participants will receive a saline solution (0.9% NaCl) administered as 3 drops per nostril, three times daily for six consecutive days.	Device	Saline Placebo Drops

Primary outcome

Change in Purulent Rhinitis Symptoms
Time frame: 6 days
Evaluate the change in symptoms of purulent rhinitis, such as nasal congestion and mucosal discharge, in the experimental group compared to the control group.

3 secondary outcomes

Change in Antibiotic Use
Time frame: 6 days
Change in nasal obstruction
Time frame: 6 days
Incidence of Treatment-Emergent Adverse Events
Time frame: 6 days

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 29 Jun 2025.
Background: PubMed 16861253Arroll B, Kenealy T. Are antibiotics effective for acute purulent rhinitis? Systematic review and meta-analysis of placebo controlled randomised trials. BMJ. 2006 Aug 5;333(7562):279. doi: 10.1136/bmj.38891.681215.AE. Epub 2006 Jul 21.
Background: PubMed 29114245Orru G, Demontis C, Mameli A, Tuveri E, Coni P, Pichiri G, Coghe F, Rosa A, Rossi P, D'hallewin G. The Selective Interaction of Pistacia lentiscus Oil vs. Human Streptococci, an Old Functional Food Revisited with New Tools. Front Microbiol. 2017 Oct 24;8:2067. doi: 10.3389/fmicb.2017.02067. eCollection 2017.
Background: PubMed 34220777Di Pierro F, Sagheddu V, Galletti S, Forti M, Elli M, Bertuccioli A, Gaeta S. Antibacterial Activity of a Fractionated Pistacia lentiscus Oil Against Pharyngeal and Ear Pathogens, Alone or in Combination With Antibiotics. Front Microbiol. 2021 Jun 17;12:686942. doi: 10.3389/fmicb.2021.686942. eCollection 2021.
Individual participant dataSharing planned: No

Related trials for Rhinitis Acute

Recruiting
Probiotic Trial for URTI Prevention in Healthy Adults
Upper Respiratory Tract Infections
Not yet recruiting
Enhanced Telemedicine in Primary Care for Acute Respiratory Tract Infections Study
Acute Respiratory Tract Infection, Ear Infection
Not yet recruitingObservational study
Post-market Clinical Follow-up Study of an Isotonic Saline Solution for the Relief of Nasal Congestion in Infants and Toddlers
Nasal Congestion, Common Cold
Recruiting
Effect of Immune X on Common Cold Incidence in Healthy Adults
Common Cold, Upper Respiratory Tract Infection (URTI)
Not yet recruitingPhase 3
A Study to Evaluate DEP114 for the Treatment of Acute Exacerbation of Persistent Allergic Rhinitis in Children Aged 6 to Under 12 Years
Persistent Allergic Rhinitis

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.

The record lists no contact. Use the official record to reach the sponsor.

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

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 3 inclusion and 4 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 29 Jun 2025. 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 Italy. 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?

Change in Purulent Rhinitis Symptoms (time frame: 6 days). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06758804, which also lists 3 linked publications.

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 29 Jun 2025.