N/A
N=186
Symbiofilm Trial in Allergic Kids (SYMBIOFILM-TAK)
Common Cold · Allergy
Bottom Line
View on ClinicalTrials.gov: NCT05034328 ↗Enrolled (actual)
186
Serious AEs
0.0%
Results posted
Jan 2025
Primary outcome: Primary: AUC (Area Under Curve) of the Wisconsin Upper Respiratory Symptoms Survey for Kids (WURSS-K) During the 10-day Treatment Period — 36.56; 55.54 scores on WURSS-K scale* days — p=<0.05
Study Design & Population
- Study type
- Observational
- Phase
- N/A
- Interventions
- Healsea® Children (Device); Conventional therapies for common cold (Other)
- Age
- Pediatric · 6+ yrs
- Sex
- All
- Sponsor
- Lallemand Pharma AG
- Primary completion
- Nov 2022
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY AUC (Area Under Curve) of the Wisconsin Upper Respiratory Symptoms Survey for Kids (WURSS-K) During the 10-day Treatment Period |
36.56; 55.54 | <0.05 sig |
| SECONDARY Number of Days With Runny Nose |
7.4; 9.4 | 0.7026 |
| SECONDARY Number of Days With Stuffy Nose |
6.8; 8.6 | 0.6322 |
| SECONDARY Number of Days With Sneezing |
6.1; 5.9 | 0.9598 |
| SECONDARY Number of Days With Sore Throat |
3.9; 5.2 | 0.1016 |
| SECONDARY Number of Days With Cough |
6.1; 7.1 | 0.3954 |
| SECONDARY Number of Days With "Feeling Tired" |
4.8; 6.4 | 1.218 |
| SECONDARY Respiratory Complication Requiring Antibiotic Prescription After the10-day Treatment Period |
1; 2 | >0.05 |
| SECONDARY Number of Participants With Use of Concomitant Treatments |
53; 66 | 0.0010 sig |
Summary
Healsea® Children is a seawater-based nasal spray supplemented with a natural Symbiofilm® extract (0.02%) isolated from marine bacteria. Symbiofilm has antibiofilm activity against various bacterial pathogens involved in respiratory tract infections.Healsea® Children is indicated in the cleaning and moistening of nasal mucosa during common cold and rhinitis for children above 6 years.
This non interventional post-market clinical investigation aimed to confirm the benefit of Healsea® Children in real life setting in children with perennial allergy who are more prone to common cold.
Eligibility Criteria
Inclusion Criteria
- Male/Female subjects ≥6 and ≤10-year-old
- AsIgE (Allergy specific IgE) ≥ class 2 (RAST) or positive prick test for at least one perennial allergen
- Acute infectious rhinitis/rhinosinusitis for ≤48h before trial entry
- Patient presenting with fever ≥ 37.5 °C at screening
- Symptoms of headache, muscle ache, chilliness, sore throat, blocked nose, runny nose, cough, sneezing with a total score ≤9 (according to a physician-rated symptom score; scale: 0 to 3 [0: no symptom to 3: severe intensity])
- At least one of these symptoms: sore throat, runny nose or blocked nose (i.e., with a score ≥1)
- Written consent obtained from parent/legal guardians
- Written assent obtained from patient
Exclusion Criteria
- Known hypersensitivity/allergy to any component of the test device
- Medical history 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
- History of nasal or sinus surgery that in the opinion of the investigator may influence symptom scores
- Antibiotic intake within 2 weeks before screening
- Systemic corticosteroids within 4 weeks before screening
- Antihistamines intake for allergy when treatment was started from less than 4 weeks
- Bacterial lysate intake within 6 months before screening
- Chronic decongestant use
- Recent (within the previous 2 days) intake of a common cold medicine that in the opinion of the investigator may influence symptom score at screening (NSAID, nasal decongestants, cough medicines)
Data sourced from ClinicalTrials.gov (NCT05034328). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.