Probiotic Supplementation in Children Affected by Upper Respiratory Infections (PROBIOS2021)

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

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 Overview

• Status: Active, not recruiting
• Conditions: Upper Respiratory Tract Infection
• Intervention / Treatment: Dietary supplement: Probiotic supplement; Dietary supplement: Placebo

• Study Type: Interventional
• Enrollment (Actual): 128
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Italy
  • Milano, Italy, 20122
    • Fondazione IRCCS CA' Granda Ospedale Maggiore Policlinico

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Probiotics; Probiotic supplement: Mix of probiotic strails. Administration: 1 stick per day or 5 drops per day. Study duration for each patient: 14 days.	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.; Other Names: Ofmom SynterAct BIMBI
Placebo Comparator: Placebo; Placebo: Medium Chain Triglycerides. Administration: 1 stick per day or 5 drops per day. Study duration for each patient: 14 days.	Dietary supplement: Placebo; Drops: Medium Chain Triglycerides, vegetal oil, E471, and maltodextrin; Stick: Maltodextrin.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Gastrointestinal symptoms	Evaluation of the gastrointestinal symptoms by interview	Approximatively 7 days
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
Adverse events	Evaluation of differences in clinical effects in subjects with or without antibiotics collected by interview	Approximatively 15 days

Collaborators and Investigators

• Sponsor: Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico
• Investigators: Principal Investigator: Carlo V Agostoni, Prof, Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico, Milano, Italy

Study record dates

Study Major Dates

• Study Start (Actual): September 1, 2021
• Primary Completion (Actual): June 30, 2023
• Study Completion (Estimated): June 30, 2024

Study Registration Dates

• First Submitted: September 19, 2023
• First Submitted That Met QC Criteria: September 19, 2023
• First Posted (Actual): September 25, 2023

Study Record Updates

• Last Update Posted (Actual): September 29, 2023
• Last Update Submitted That Met QC Criteria: September 27, 2023
• Last Verified: September 1, 2023

More Information

Terms related to this study

• Keywords: children; probiotic; respiratory infection
• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Infections; Respiratory Tract Infections
• Other Study ID Numbers: 726_2021bis

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No