NCT06052540

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).

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
128

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Sep 2021

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2021

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2023

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

September 19, 2023

Completed
6 days until next milestone

First Posted

Study publicly available on registry

September 25, 2023

Completed
9 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2024

Completed
Last Updated

September 29, 2023

Status Verified

September 1, 2023

Enrollment Period

1.8 years

First QC Date

September 19, 2023

Last Update Submit

September 27, 2023

Conditions

Upper Respiratory Tract Infection

Keywords

probioticchildrenrespiratory infection

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (3)

  • Mean change in gut microbial composition by measuring gut microbiota characterization in fecal samples

    1 year

  • Gastrointestinal symptoms

    Approximatively 7 days

  • Adverse events

    Approximatively 15 days

Study Arms (2)

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.

Dietary Supplement: Probiotic supplement

Placebo

PLACEBO COMPARATOR

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

Dietary Supplement: Placebo

Interventions

Probiotic supplementDIETARY_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.

Also known as: Ofmom SynterAct BIMBI
Probiotics
PlaceboDIETARY_SUPPLEMENT

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

Placebo

Eligibility Criteria

Age29 Days - 4 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • 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

You may not qualify if:

  • Presence of pathologies associated with immunosuppression or ongoing immunosuppressant treatments
  • Hospitalisation/hospitalisation
  • Diarrhea at enrollment
  • No signed informed consent

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico

Milan, 20122, Italy

Location

Related Publications (1)

  • 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.

    PMID: 40085083DERIVED

MeSH Terms

Conditions

Respiratory Tract Infections

Condition Hierarchy (Ancestors)

InfectionsRespiratory Tract Diseases

Study Officials

  • Carlo V Agostoni, Prof

    Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico, Milano, Italy

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Researcher

Study Record Dates

First Submitted

September 19, 2023

First Posted

September 25, 2023

Study Start

September 1, 2021

Primary Completion

June 30, 2023

Study Completion

June 30, 2024

Last Updated

September 29, 2023

Record last verified: 2023-09

Locations

IT(1)