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

NCT06218225 | Completed

• 1 other identifier: IMMUNOJR
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 1

Brief 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)

Outcome Measures

Primary Outcomes (1)

• Evaluation of the reduction in the severity of symptoms related to Acute Respiratory Tract Infections

  Evaluation of the reduction of illness-specific symptoms during an ARI by means of validated 15-items questionnaire (WURSS-k)

  For each infectious event, it should be filled in on the first day of symptoms, on the third day of symptoms, and if symptoms persist, it should also be filled in on the seventh day of symptoms.

Secondary Outcomes (1)

• Evaluation of the reduction in the number of Acute Respiratory Tract Infections

  T0 (first visit), T1 (4 months later - end of treatment)

Study Arms (2)

Verum

EXPERIMENTAL

Partecipants received a food supplement with the innovative IMMUREMEDY®-B complex and Lactobacillus rhamnosus CRL1505.

Dietary Supplement: Verum

Placebo

PLACEBO COMPARATOR

Partecipants received a food supplement in the same primary packaging of the verum, but without active substances

Dietary Supplement: Placebo

Interventions

Verum DIETARY_SUPPLEMENT

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

Verum

Placebo DIETARY_SUPPLEMENT

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

Placebo

Eligibility Criteria

• Age: 3 Years - 10 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• Both sexes children aged 3-10 years, with a number of respiratory tract infectious events in the previous year greater than 4.

You may not qualify if:

• Acute upper respiratory tract or other infection within 7 days prior to enrollment, cystic fibrosis, immunodeficiency syndromes, abnormalities respiratory tract anatomy, use of immunostimulant drugs or immunosuppressants in the previous 4 weeks.

Sponsors & Collaborators

• Azienda Ospedaliera Universitaria Policlinico "G. Martino": lead

Study Sites (1)

Gioacchino Calapai

Messina, 98125, Italy

Location

MeSH Terms

Conditions

Infections

Interventions

calcium D-pantothenate, L-cysteine drug combination

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, CARE PROVIDER
• Masking Details: Different batch code assigned to products, same labeling
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Randomized double blind verum vs placebo

Study Record Dates

• First Submitted: January 12, 2024
• First Posted: January 23, 2024
• Study Start: October 15, 2022
• Primary Completion: March 31, 2023
• Study Completion: April 30, 2023
• Last Updated: February 1, 2024

Record last verified: 2023-11

Locations

IT (1)