Clinical trial NCT06758804: Efficacy of Winterized Pistacia Lentiscus Oil in Reducing Purulent Bacterial Overinfection of Pediatric Rhinitis
Official title: Evaluation of the Efficacy of Winterized Pistacia Lentiscus Oil in Reducing Purulent Bacterial Overinfection of Pediatric Rhinitis: A Multicenter Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Rhinitis Acute
Lead sponsor: Liaquat University of Medical & Health Sciences
Sponsor class: OTHER
Collaborators: name: Università degli Studi dell'Insubria
First posted: 2025-01-06
Enrollment: 155
Sex: ALL
Minimum age (years): 2
Maximum age (years): 10
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.

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.

Eligibility criteria: Inclusion Criteria:

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

Exclusion Criteria:

* 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.

Primary outcomes:
measure: Change in Purulent Rhinitis Symptoms
timeFrame: 6 days
Secondary outcomes:
measure: Change in Antibiotic Use
timeFrame: 6 days
measure: Change in nasal obstruction
timeFrame: 6 days
measure: Incidence of Treatment-Emergent Adverse Events
timeFrame: 6 days
Other outcomes:
Locations:
city: Varese
country: Italy
facility: Università degli Studi dell'Insubria
Study officials:
References:
citation: 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.
citation: 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.
citation: 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.