Probiotic Supplementation in Children Affected by Upper Respiratory Infections

Upper Respiratory Tract Infection Clinical Trial

— PROBIOS2021  

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT06052540
• Other study ID #: 726_2021bis
• Status: Active, not recruiting
• Phase: N/A
• Start date: September 1, 2021
• Est. completion date: June 30, 2024

Study information

• Verified date: September 2023
• Source: Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 128
• Est. completion date: June 30, 2024
• Est. primary completion date: June 30, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 29 Days to 4 Years

Eligibility

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

Related Conditions & MeSH terms

• Infections
• Respiratory Tract Infections
• Upper Respiratory Tract Infection

Intervention

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.
• Placebo
Drops: Medium Chain Triglycerides, vegetal oil, E471, and maltodextrin Stick: Maltodextrin.

Locations

Country	Name	City	State
Italy	Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico	Milano

Sponsors (1)

Lead Sponsor	Collaborator
Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Approximatively 7 days
Secondary	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	1 year
Secondary	Gastrointestinal symptoms	Evaluation of the gastrointestinal symptoms by interview	Approximatively 7 days
Secondary	Adverse events	Evaluation of differences in clinical effects in subjects with or without antibiotics collected by interview	Approximatively 15 days