NCT06052540

Probiotic Supplementation in Children Affected by Upper Respiratory Infections

Effetto Della Supplementazione di Una Miscela di Ceppi Probiotici (Bifidobacterium Breve M-16V, Bifidobacterium Lactis HN019, Lactobacillus Rhamnosus HN001) in Bambini Febbrili Con Infezioni Delle Alte Vie Respiratorie

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 128 (actual)
• Sponsor: Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico · Academic / Other
• Sex: All
• Age: 29 Days – 4 Years
• Healthy volunteers: Not accepted

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).

Conditions

• Upper Respiratory Tract Infection

Interventions

Type	Name	Description
DIETARY_SUPPLEMENT	Probiotic supplement	* Stick: Bifidobacterium breve M-16V, Bifidobacterium lactis HN019, Lactobacillus rhamnosus HN001 + Maltodestrins * Drops: Bifidobacterium breve M-16V, Bifidobacterium lactis HN019, Lactobacillus rhamnosus HN001 + Medium chain triglycerides, vegetable fats, emulsifier, and maltodextrin.
DIETARY_SUPPLEMENT	Placebo	* Drops: Medium Chain Triglycerides, vegetal oil, E471, and maltodextrin * Stick: Maltodextrin.

Timeline

• Start date: 2021-09-01
• Primary completion: 2023-06-30
• Completion: 2024-06-30
• First posted: 2023-09-25
• Last updated: 2023-09-29

Locations

1 site across 1 country: Italy