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

Immunomodulation Clinical Trial

Official title:

Randomized, Double-blind, Placebo-controlled Clinical Trial to Evaluate the Effects of an Immune-boosting Food Supplement on the Severity and Frequency of Pediatric Respiratory Tract Infections

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT06218225
• Other study ID #: IMMUNOJR
• Status: Completed
• Phase: N/A
• Start date: October 15, 2022
• Est. completion date: April 30, 2023

Study information

• Verified date: November 2023
• Source: Azienda Ospedaliera Universitaria Policlinico "G. Martino"
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 120
• Est. completion date: April 30, 2023
• Est. primary completion date: March 31, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 3 Years to 10 Years

Eligibility

Inclusion Criteria:

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

Exclusion Criteria:

• 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.

Related Conditions & MeSH terms

• Communicable Diseases
• Immunomodulation
• Infections
• Respiratory Tract Infections
• Respiratory Tract; Infection, Upper (Acute)

Intervention

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
• 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

Locations

Country	Name	City	State
Italy	Gioacchino Calapai	Messina

Sponsors (1)

Lead Sponsor	Collaborator
Azienda Ospedaliera Universitaria Policlinico "G. Martino"

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Evaluation of the reduction in the number of Acute Respiratory Tract Infections	Evaluation of the reduction in the number of infectious events during the 4-months study duration, based on how many times each patient completed the WURSS-k questionnaire	T0 (first visit), T1 (4 months later - end of treatment)