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

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT06052540

Acronym

PROBIOS2021

Enrollment

128

Registered

2023-09-25

Start date

2021-09-01

Completion date

2024-06-30

Last updated

2023-09-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Upper Respiratory Tract Infection

Keywords

probiotic, children, respiratory infection

Brief 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).

Interventions

DIETARY_SUPPLEMENTProbiotic 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_SUPPLEMENTPlacebo

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

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

TRIPLE (Subject, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

29 Days to 4 Years

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame	Description
Mean duration of fever in days by measuring body temperature	Approximatively 7 days	To assess the effects of a probiotic supplement compaerd to a placebo on mean duration and intensity of fever measured by a thermometer

Secondary

Measure	Time frame	Description
Mean change in gut microbial composition by measuring gut microbiota characterization in fecal samples	1 year	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
Gastrointestinal symptoms	Approximatively 7 days	Evaluation of the gastrointestinal symptoms by interview
Adverse events	Approximatively 15 days	Evaluation of differences in clinical effects in subjects with or without antibiotics collected by interview

Countries

Italy

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026