Status:
COMPLETED
HEALSea Nasal Spray for Prevention of Infections in Children
Lead Sponsor:
Lallemand Pharma AG
Conditions:
Healthy Subjects
Eligibility:
All Genders
6-17 years
Phase:
PHASE2
PHASE3
Brief Summary
Healsea® Children is a class IIa medical device. This is an isotonic seawater-based nasal spray supplemented with a natural Symbiofilm™ extract (0.02%) isolated from marine bacteria. Healsea® Children...
Detailed Description
Upper respiratory tract infections (URTIs) and sino-nasal symptoms are very frequent. Human rhinovirus (more than 100 serotypes) is the most common cause, accounting up to 50% viral rhinitis episodes...
Eligibility Criteria
Inclusion
- Male/Female subjects ≥6 and \<18-year-old
- No respiratory tract infection within 15 days before trial entry and at trial entry
- Written consent obtained from parent/legal guardians
- Written assent obtained from patient
- Availability of a smartphone throughout the study and an internet connection.-
Exclusion
- Known hypersensitivity/allergy to any component of the test device,
- Subject with severe asthma, perennial allergy, cystic fibrosis, immunodeficiency or ciliary dyskinesis,
- Body temperature ≥ 37.5°
- Medical history or any current disease that is considered by the investigator as a reason for non-inclusion,
- Severe nasal septum deviation or other condition that could cause nasal obstruction such as the presence of nasal polyps,
- Antibiotic (systemic or per nasal route) or antivirals (systemic) intake within 2 weeks before screening,
- Systemic or local corticosteroids (nasal route or inhalation) within 4 weeks before screening,
- Antihistamines intake for allergy when treatment was started from less than 4 weeks before screening,
- Vaccination against flu or COVID-19 within 6 months before screening,
- Chronic decongestant use within 2 weeks before screening,
- Bacterial lysates or immunostimulants (food supplements excluded) used for prevention of infection within the 6 months before the screening,
- Prebiotics, probiotics used for prevention of infection within 6 months before the screening,
- Pregnant/Lactating female or with sexual activity without hormonal contraception, intrauterine device or barrier methods.
Key Trial Info
Start Date :
November 25 2024
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 23 2025
Estimated Enrollment :
139 Patients enrolled
Trial Details
Trial ID
NCT06582589
Start Date
November 25 2024
End Date
April 23 2025
Last Update
July 22 2025
Active Locations (8)
Enter a location and click search to find clinical trials sorted by distance.
1
Multiprofile Hospital for Active Treatment Sveti Ivan Rilski -2003 OOD
Dupnitsa, Bulgaria, 2600
2
Medical Center Plovdimed Ltd
Plovdiv, Bulgaria, 4023
3
Medical Center Iskar EOOD
Sofia, Bulgaria, 1000
4
Medical Center Polymed AD
Sofia, Bulgaria, 1303