Symbiofilm Trial in Allergic Kids (SYMBIOFILM-TAK)
Condition: Common Cold; Allergy
MeSH terms: Common Cold
Study type: Observational

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.
    

Detailed description: 
      Healsea® Children is a seawater-based nasal spray supplemented with a natural Symbiofilm®
      extract (0.02%) isolated from marine bacteria. Symbiofilm® is an exopolymeric composition
      with emulsifying properties, in vitro antibiofilm activity and detachment properties against
      various bacterial pathogens involved in respiratory tract infections. Symbiofilm® has no
      bacteriostatic nor bactericidal activities. Healsea® Children is indicated in the cleaning
      and moistening of nasal mucosa during common cold and rhinitis.

      The common cold is an acute viral infection of the upper respiratory tract, involving, to
      variable degrees, sneezing, nasal congestion and discharge (rhinorrhea), sore throat, cough,
      low-grade fever, headache, and malaise (1). It can be caused by members of several families
      of viruses; the most common are rhinoviruses. Acute viral rhinitis is generally
      self-limiting. In children where the illness is not self-limiting and extends beyond 7-10
      days, many agree that a bacterial infection is likely (1). Bacterial over infections and
      progression to a chronic state are favoured by the formation of biofilms, which facilitate
      bacterial growth and persistence as well as reducing antibiotic efficacy (2-3).

      Allergic diseases may play a particular role in promoting the respiratory infection
      recurrences (4). The physiological immune response is impaired in allergic subjects and
      allergic inflammation favours predisposition to respiratory infections. Subjects with
      allergic disorders may have functional defect of type 1 immune response that is relevant in
      fighting infections (5-6).

      Allergic rhinitis (AR) may affect up to 40% of the paediatric population. Nasal symptoms are
      caused by exposure to an allergen to which a patient is sensitized.

      AR is characterized by typical nasal symptoms and immunoglobulin E (IgE) -mediated
      inflammation. The allergic inflammatory process releases many cytokines and other
      proinflammatory proteins. Inflammation caused by nasal allergy leads to obstruction, fluid
      accumulation and acute disease. If these diseases are unsuccessfully treated, a chronic state
      of inflammation, obstruction, and infection develops that can cause mucosal damage and,
      ultimately, chronic disease (7).

      For these reasons, the paediatric IgE-dependent allergic population that is more prone to
      common cold represents a suitable target for Healsea® Children (8-9).

      During this prospective post-market clinical investigation, IgE-dependent allergic children
      with early symptoms of infectious rhinitis will be followed, children being treated with
      Healsea® Children on top of common cold conventional therapies or with conventional therapies
      only (excluded nasal irrigation).

      Conventional therapies for non-complicated infectious rhinitis are symptomatic but are not
      without side effects. For example, decongestant use can increase blood pressure,
      antihistamine intake is associated with drowsiness.

      Healsea® Children represents an interesting alternative that can not only improve acute
      infectious rhinitis symptomatology but could also limit the complication and progression to
      chronic state.

      This non interventional post-market clinical investigation aimed to confirm the benefit of
      Healsea® Children in a real life setting in children with perennial allergy.
    

Intervention name(s): Healsea® Children; Conventional therapies for common cold
Intervention type(s): Device; Other
Intervention description(s): Children will be administered Healsea Children , one puff (1-2 sec) in each nostril twice a day for 10 days on top of conventional therapies, as needed; Children will receive conventional therapies for common cold, nasal irrigation excluded (antipyretics, mucolytics, decongestants, antitussives, systemic and topical corticosteroids, antibiotics)
Other intervention name(s): Conventional therapies for common cold
Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        The study population comprises children 6 to10 years old with perennial allergy and early
        symptoms of common cold.

        The recruitment will be competitive in both group, exposed to Healsea® Children or not
        exposed to Healsea® Children. However, when 100 patients will be recruited in one group,
        the recruitment will be stopped in this group but will continue in the other group until
        100 patients to be enrolled.
      
Keywords: Infectious rhinitis, nasal irrigation, perennial allergy