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NCT06582589: HEALSPIC
HEALSea Nasal Spray for Prevention of Infections in Children
Phase 2, PHASE3 trial testing Healsea Children in Healthy Subjects in 139 participants. Completed in 23 April 2025.
23 April 2025
Quick facts
| Lead sponsor | Lallemand Pharma AG |
|---|---|
| Phase | Phase 2, PHASE3 |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | none |
| Primary purpose | prevention |
| Enrollment | 139 |
| Start date | 25 November 2024 |
| Primary completion | 23 April 2025 |
| Estimated completion | 23 April 2025 |
| Sites | 8 locations across Bulgaria |
Drugs / interventions tested
- Healsea Children
Conditions studied
- Healthy Subjects — all drugs for Healthy Subjects →
Sponsor
Lallemand Pharma AG — full company profile →
Who can join
Adults 6 to 17, any sex, with Healthy Subjects. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
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 is indicated in children above 6 years to clean and moisten the nose during colds. Symbiofilm™, which is not a medicinal product is able to protect the nasal mucosa from viruses' entrance by forming a protective barrier on the nasal mucosa. By targeting the nose as entry points for viruses, we hypothesise that Healsea® Children used regularly during the respiratory virus season may prevent upper respiratory tracts infections such as cold or flu with nasal symptoms. The main objective of this premarket clinical investigation is thus to assess the efficacy of Healsea® Children to prevent upper respiratory tract infections with nasal symptoms in healthy children during 3 treatment periods of 28 days interspersed by 2 wash-out periods of 10 days when compared to children not taking Healsea® Children. 138 children will be randomised in the study, 64 in the Healsea® Children group and 64 in the non-treated group. The subjects (or their parents) will be asked to report the upper respiratory tract infections with nasal symptoms and complication they may have during the study to the physician in charge of the study conduct. Two study visits and 3 telephone calls are scheduled. The subjects will also complete an electronic diary to report nasal symptoms and adverse event other than upper respiratory tracts infections.
Publications & conference data
No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.
Verify or expand the search:
- PubMed search for NCT06582589
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
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Other Lallemand Pharma AG trials
Trials by the same sponsor.
- NCT06613906 — Prevention With Healsea in Adults Against Respiratory Infection Study · NA · completed
- NCT06649032 — Survey of Incidence of Respiratory Tract Infections · completed
- NCT05819203 — BАbykids Spray In Common Cold · NA · completed
- NCT05819190 — Testing the Efficacy in Adults With Cold of HEalsea Rescue* · NA · completed
- NCT05015530 — Impact of Symbiofilm On Nasal Microbiota · completed
Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT06582589 (US National Library of Medicine, public domain)
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Lallemand Pharma AG
- Last refreshed: 22 July 2025
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT06582589.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing