Probiotic Supplementation in Children Affected by Upper Respiratory Infections

Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico128 enrolled

Overview

The goal of this randomized non-pharmacological Intervention study is to evaluate the effects of probiotic supplements (Bifidobacterium breve M-16V, Bifidobacterium lactis HN019, Lactobacillus rhamnosus HN001) on children affected by upper respiratory tract infections. The main questions it aims to answer are: * probiotic formulation can reduce intensity and duration of fever in children affected by upper respiratory tract infections * probiotic formulation can influence the gut microbiota composition in children affected by upper respiratory tract infections Participants will be asked to take probiotic supplements or placebo for 14 days and to collect three fecal samples: before probiotic supplementation (T0), 14 days after probiotic supplementation (T1), and 12 months after the enrollment (T2).

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

TRIPLE

Enrollment

128

Conditions

Upper Respiratory Tract Infection

Interventions

Eligibility

Sex: ALLMin age: 29 DaysMax age: 4 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Access to the Emergency room with fever and upper respiratory tract infection * Age \> 28 days and ≤ 4 years * Signature of informed consent by parents or guardian Exclusion Criteria: * Presence of pathologies associated with immunosuppression or ongoing immunosuppressant treatments * Hospitalisation/hospitalisation * Diarrhea at enrollment * No signed informed consent

Outcomes

Primary Outcomes

Mean duration of fever in days by measuring body temperature

To assess the effects of a probiotic supplement compaerd to a placebo on mean duration and intensity of fever measured by a thermometer

Time frame: Approximatively 7 days

Secondary Outcomes

Mean change in gut microbial composition by measuring gut microbiota characterization in fecal samples

To assess the effects of a probiotic supplement compared to a placebo on gut microbiota characteristics at baseline, 14 days and 12 months by generation Sequencing, real-time PCR, and typing PCR

Time frame: 1 year

Gastrointestinal symptoms

Evaluation of the gastrointestinal symptoms by interview

Time frame: Approximatively 7 days

Adverse events

Evaluation of differences in clinical effects in subjects with or without antibiotics collected by interview

Time frame: Approximatively 15 days