Probiotic Supplementation in Children Affected by Upper Respiratory Infections

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

128 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-09-01

Study Completion Date

2024-06-30

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).

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Detailed Description

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Conditions

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Upper Respiratory Tract Infection

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

Study Groups

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Probiotics

Probiotic supplement: Mix of probiotic strails. Administration: 1 stick per day or 5 drops per day. Study duration for each patient: 14 days.

Group Type ACTIVE_COMPARATOR

Probiotic supplement

Intervention Type DIETARY_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

Placebo: Medium Chain Triglycerides. Administration: 1 stick per day or 5 drops per day. Study duration for each patient: 14 days.

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DIETARY_SUPPLEMENT

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

Interventions

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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.

Intervention Type DIETARY_SUPPLEMENT

Placebo

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

Intervention Type DIETARY_SUPPLEMENT

Other Intervention Names

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Ofmom SynterAct BIMBI

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

Minimum Eligible Age

29 Days

Maximum Eligible Age

4 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No