Effect of an Immune-boosting Food Supplement on the Severity and Frequency of Pediatric Respiratory Tract Infections
Condition: Immunomodulation; Respiratory Tract; Infection, Upper (Acute)
MeSH terms: Infections; Communicable Diseases; Respiratory Tract Infections
Study type: Interventional

Summary: 
      The goal of this clinical trial is to evaluate the efficacy of the product in developing
      immune reinforcement that results in decreased susceptibility to respiratory infections of
      viral origin in children aged 3 to 10 years with a number of respiratory tract infectious
      events in the previous year greater than 4. The main questions it aims to answer are:

        -  Has the number of infectious events been reduced from last year?

        -  Does the severity of symptoms decrease with the use of the product?

      Participants will be treated for 4 months. Treatment efficacy will be evaluated by:

        -  2 scheduled visits with the investigating pediatrician (T0 - enrollment and start of
           treatment; T1- end of treatment).

        -  Verification of progress during the study by scheduled telephone meetings.

        -  The use of a diary where the patient or parent/caregiver will report all events (even
           mild) affecting the respiratory tract, taking care to fully complete the Wisconsin Upper
           Respiratory Symptom Survey for kids (WURSS-k) questionnaire.
    

Detailed description: 
      The immune system is a complex network consisting of organs, tissues, cells and the
      substances they produce. It has the function of protecting the body from external agents
      (including infectious agents) by activating three different types of response: the innate
      response, the adaptive response, and the mechanical or chemical response. The innate and
      adaptive response are activated together, one modulating the other. The innate or natural
      response represents a first line of defense. The adaptive or specific response is a slower
      but more powerful and targeted defensive response and enables the creation of immunological
      memory.

      In the pediatric setting in the early months, and in the later first years of life, where the
      "immunological memory" has not yet strengthened, infectious events such as fever, flu, colds,
      throat discomfort, cough, respiratory infections, sore throat, various respiratory tract
      ailments, gastrointestinal diseases or related only to the intestinal tract occur frequently.
      It will take time for it to strengthen, and for the little one to be immune to a bacterial
      infection, but there are remedies to help. A healthy lifestyle, physical activity and a
      balanced diet that allows the right amount of protein, vitamins and minerals can strengthen
      the immune system. In some cases, where healthy diet and lifestyle needed support, the use of
      natural substances with immune-stimulating action proves useful.

      The tested product is a dietary supplement specifically designed to modulate immune defenses
      in children. It contains the innovative IMMUREMEDY®-B complex and Lactobacillus rhamnosus
      CRL1505. Zinc and vitamins B6, B12, C, and D contribute to normal immune system function.
      Elderberry and acerola support the body's natural defenses. Lactobacillus rhamnosus CRL1505
      is a probiotic that promotes the balance of the flora intestinal flora. Several clinical
      studies have shown that it can reduce the incidence of pediatric infections, including
      respiratory tract infections.

      The goal of this clinical trial is to evaluate the efficacy of the product in developing
      immune reinforcement that results in decreased susceptibility to respiratory infections of
      viral origin in children aged 3 to 10 years with a number of respiratory tract infectious
      events in the previous year greater than 4.

      Treatment consists of taking one single-dose bottle daily for a total of 4 months as follows:

      1st cycle - 30 days use of study product or placebo Cycle 2 - first 15 days washout,
      remaining 15 days use of study product or placebo Cycle 3 - first 15 days washout, remaining
      15 days use of study product or placebo 4th cycle - 30-day washout Numerosity and severity of
      infectious events will be assessed during meetings with the pediatrician and through a diary
      where the patient or parent/caregiver will report all events (even mild) affecting the
      respiratory tract, taking care to fully complete the Wisconsin Upper Respiratory Symptom
      Survey for kids (WURSS-k) questionnaire.
    

Intervention name(s): Verum; Placebo
Intervention type(s): Dietary Supplement; Dietary Supplement
Intervention description(s): 1st cycle - 30 days continuous use Cycle 2 - first 15 days washout, remaining 15 days use of study product Cycle 3 - first 15 days washout, remaining 15 days use of study product 4th cycle - 30-day washout; 1st cycle - 30 days continuous use Cycle 2 - first 15 days washout, remaining 15 days use of placebo Cycle 3 - first 15 days washout, remaining 15 days use of placebo 4th cycle - 30-day washout
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Randomized double blind verum vs placebo
Masking: Double (Participant, Care Provider)
Primary purpose: Treatment