NCT06758804

Brief 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. The randomized controlled trial will compare the treatment group receiving nasal drops with a control group using saline solution.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
105

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jan 2025

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

December 20, 2024

Completed
13 days until next milestone

Study Start

First participant enrolled

January 2, 2025

Completed
4 days until next milestone

First Posted

Study publicly available on registry

January 6, 2025

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 3, 2025

Completed
12 days until next milestone

Study Completion

Last participant's last visit for all outcomes

June 15, 2025

Completed
Last Updated

June 29, 2025

Status Verified

June 1, 2025

Enrollment Period

5 months

First QC Date

December 20, 2024

Last Update Submit

June 27, 2025

Conditions

Rhinitis Acute

Outcome Measures

Primary Outcomes (1)

  • 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.

    6 days

Secondary Outcomes (3)

  • Change in Antibiotic Use

    6 days

  • Change in nasal obstruction

    6 days

  • Incidence of Treatment-Emergent Adverse Events

    6 days

Study Arms (2)

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)

Interventions

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.

Winterized Pistacia Lentiscus Oil Drops
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.

Saline Placebo Drops

Eligibility Criteria

Age2 Years - 10 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Università degli Studi dell'Insubria

Varese, Italy

Location

Related Publications (3)

  • 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.

    PMID: 16861253BACKGROUND

  • 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.

    PMID: 29114245BACKGROUND

  • 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.

    PMID: 34220777BACKGROUND

MeSH Terms

Conditions

Common Cold

Condition Hierarchy (Ancestors)

Respiratory Tract InfectionsInfectionsPicornaviridae InfectionsRNA Virus InfectionsVirus DiseasesRespiratory Tract Diseases

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor of Experimental Medicine and Clinical Biochemistry

Study Record Dates

First Submitted

December 20, 2024

First Posted

January 6, 2025

Study Start

January 2, 2025

Primary Completion

June 3, 2025

Study Completion

June 15, 2025

Last Updated

June 29, 2025

Record last verified: 2025-06

Data Sharing

IPD Sharing
Will not share

Locations

IT(1)