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Effect of an Immune-boosting Food Supplement on the Severity and Frequency of Pediatric Respiratory Tract Infections

NCT06218225 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 120

Last updated 2024-02-01

No results posted yet for this study

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.

Conditions

  • Immunomodulation
  • Respiratory Tract; Infection, Upper (Acute)

Interventions

DIETARY_SUPPLEMENT

Verum

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

DIETARY_SUPPLEMENT

Placebo

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

Sponsors & Collaborators

  • Azienda Ospedaliera Universitaria Policlinico "G. Martino"

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
3 Years
Max Age
10 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2022-10-15
Primary Completion
2023-03-31
Completion
2023-04-30

Countries

  • Italy

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06218225 on ClinicalTrials.gov