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

Primary Purpose

Upper Respiratory Tract Infection

Status
Active
Phase
Not Applicable
Locations
Italy
Study Type
Interventional
Intervention
Probiotic supplement
Placebo
Sponsored by
Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Upper Respiratory Tract Infection focused on measuring probiotic, children, respiratory infection

Eligibility Criteria

29 Days - 4 Years (Child)All SexesDoes not accept 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

Sites / Locations

  • Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

Probiotics

Placebo

Arm Description

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

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

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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
Gastrointestinal symptoms
Evaluation of the gastrointestinal symptoms by interview
Adverse events
Evaluation of differences in clinical effects in subjects with or without antibiotics collected by interview

Full Information

First Posted
September 19, 2023
Last Updated
September 27, 2023
Sponsor
Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico
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1. Study Identification

Unique Protocol Identification Number
NCT06052540
Brief Title
Probiotic Supplementation in Children Affected by Upper Respiratory Infections
Acronym
PROBIOS2021
Official Title
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
Study Type
Interventional

2. Study Status

Record Verification Date
September 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
September 1, 2021 (Actual)
Primary Completion Date
June 30, 2023 (Actual)
Study Completion Date
June 30, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Upper Respiratory Tract Infection
Keywords
probiotic, children, respiratory infection

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
128 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Probiotics
Arm Type
Active Comparator
Arm Description
Probiotic supplement: Mix of probiotic strails. Administration: 1 stick per day or 5 drops per day. Study duration for each patient: 14 days.
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Placebo: Medium Chain Triglycerides. Administration: 1 stick per day or 5 drops per day. Study duration for each patient: 14 days.
Intervention Type
Dietary Supplement
Intervention Name(s)
Probiotic supplement
Other Intervention Name(s)
Ofmom SynterAct BIMBI
Intervention Description
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
Intervention Name(s)
Placebo
Intervention Description
Drops: Medium Chain Triglycerides, vegetal oil, E471, and maltodextrin Stick: Maltodextrin.
Primary Outcome Measure Information:
Title
Mean duration of fever in days by measuring body temperature
Description
To assess the effects of a probiotic supplement compaerd to a placebo on mean duration and intensity of fever measured by a thermometer
Time Frame
Approximatively 7 days
Secondary Outcome Measure Information:
Title
Mean change in gut microbial composition by measuring gut microbiota characterization in fecal samples
Description
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
Time Frame
1 year
Title
Gastrointestinal symptoms
Description
Evaluation of the gastrointestinal symptoms by interview
Time Frame
Approximatively 7 days
Title
Adverse events
Description
Evaluation of differences in clinical effects in subjects with or without antibiotics collected by interview
Time Frame
Approximatively 15 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
29 Days
Maximum Age & Unit of Time
4 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Carlo V Agostoni, Prof
Organizational Affiliation
Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico, Milano, Italy
Official's Role
Principal Investigator
Facility Information:
Facility Name
Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico
City
Milano
ZIP/Postal Code
20122
Country
Italy

12. IPD Sharing Statement

Learn more about this trial

Probiotic Supplementation in Children Affected by Upper Respiratory Infections

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