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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:
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).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Probiotics | Active Comparator | 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 Comparator | Placebo: Medium Chain Triglycerides. Administration: 1 stick per day or 5 drops per day. Study duration for each patient: 14 days. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Probiotic supplement | Dietary Supplement |
|
| 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 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Carlo V Agostoni, Prof | Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico, Milano, Italy | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico | Milan | 20122 | Italy |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 40085083 | Derived | Bettocchi S, Comotti A, Elli M, De Cosmi V, Berti C, Alberti I, Mazzocchi A, Rosazza C, Agostoni C, Milani GP. Probiotics and Fever Duration in Children With Upper Respiratory Tract Infections: A Randomized Clinical Trial. JAMA Netw Open. 2025 Mar 3;8(3):e250669. doi: 10.1001/jamanetworkopen.2025.0669. |
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| ID | Term |
|---|---|
| D012141 | Respiratory Tract Infections |
| ID | Term |
|---|---|
| D007239 | Infections |
| D012140 | Respiratory Tract Diseases |
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|
|
| Placebo | Dietary Supplement |
|
|
| 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 |