Probiotic Supplementation in Children Affected by Upper Respiratory Infections

Not Applicable

Active, not recruiting

• Conditions: Upper Respiratory Tract Infection
• Interventions: Dietary Supplement: Probiotic supplement; Dietary Supplement: Placebo

• Registration Number: NCT06052540
• Lead Sponsor: Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico

Brief Summary

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).

Detailed Description

Not available

Study Timeline

• Study Start: 2021-09-01
• Primary Completion: 2023-06-30
• Status Verified: 2023-09
• Study First Submitted: 2023-09-19
• Study First Submitted QC: 2023-09-19
• Study First Posted: 2023-09-25
• Last Update Submitted: 2023-09-27
• Last Update Posted: 2023-09-29
• Study Completion: 2024-06-30

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 128

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Probiotics	Probiotic supplement	Probiotic supplement: Mix of probiotic strails. Administration: 1 stick per day or 5 drops per day. Study duration for each patient: 14 days.
Placebo	Placebo	Placebo: Medium Chain Triglycerides. Administration: 1 stick per day or 5 drops per day. Study duration for each patient: 14 days.

Primary Outcome Measures

Name	Time	Method
Mean duration of fever in days by measuring body temperature	Approximatively 7 days	To assess the effects of a probiotic supplement compaerd to a placebo on mean duration and intensity of fever measured by a thermometer

Secondary Outcome Measures

Name	Time	Method
Adverse events	Approximatively 15 days	Evaluation of differences in clinical effects in subjects with or without antibiotics collected by interview
Gastrointestinal symptoms	Approximatively 7 days	Evaluation of the gastrointestinal symptoms by interview
Mean change in gut microbial composition by measuring gut microbiota characterization in fecal samples	1 year	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

Trial Locations

Locations (1)

Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico; 🇮🇹 Milano, Italy