Probiotic Supplementation in Children Affected by Upper Respiratory Infections

Study Overview
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Brief Summary
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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).

Official Title
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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

Conditions
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Upper Respiratory Tract Infection

Intervention / Treatment
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* Dietary Supplement: Probiotic supplement
* Dietary Supplement: Placebo


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 29 Days
Maximum Age: 4 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Probiotics<br>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<br>* 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.<br>* Other names: Ofmom SynterAct BIMBI;|
| Placebo Comparator: Placebo<br>Placebo: Medium Chain Triglycerides. Administration: 1 stick per day or 5 drops per day. Study duration for each patient: 14 days. | Dietary Supplement: Placebo<br>* Drops: Medium Chain Triglycerides, vegetal oil, E471, and maltodextrin Stick: Maltodextrin.<br>|

What is the study measuring?
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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 |
| --- | --- | --- |
| 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 | 
| Gastrointestinal symptoms | Evaluation of the gastrointestinal symptoms by interview | Approximatively 7 days | 
| Adverse events | Evaluation of differences in clinical effects in subjects with or without antibiotics collected by interview | Approximatively 15 days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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probiotic, children, respiratory infection