Clincosm LogoSign in Get a demo

PROBIOS2021: Probiotic Supplementation in Children Affected by Upper Respiratory Infections

Sponsor
Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico (Other)
Overall Status
Active, not recruiting
CT.gov ID
NCT06052540
Collaborator
(none)
128
Enrollment
1
Location
2
Arms
33.9
Anticipated Duration (Months)
3.8
Patients Per Site Per Month

Study Details

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).

Condition or Disease Intervention/Treatment Phase
  • Dietary Supplement: Probiotic supplement
  • Dietary Supplement: Placebo
 N/A

Study Design

Study Type:
Interventional
Actual Enrollment :
128 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose:
Treatment
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
Actual Study Start Date :
Sep 1, 2021
Actual Primary Completion Date :
Jun 30, 2023
Anticipated Study Completion Date :
Jun 30, 2024

Arms and Interventions

Arm Intervention/Treatment
Active Comparator: Probiotics

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
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.
Other Names:
  • Ofmom SynterAct BIMBI

    		•
    Placebo Comparator: Placebo

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

    Dietary Supplement: Placebo
    Drops: Medium Chain Triglycerides, vegetal oil, E471, and maltodextrin Stick: Maltodextrin.

    Outcome Measures

    Primary Outcome Measures

    1. 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 Outcome Measures

    1. 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

    2. Gastrointestinal symptoms [Approximatively 7 days]

      Evaluation of the gastrointestinal symptoms by interview

    3. Adverse events [Approximatively 15 days]

      Evaluation of differences in clinical effects in subjects with or without antibiotics collected by interview

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    29 Days to 4 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico Milano Italy 20122

    Sponsors and Collaborators

    • Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico

    Investigators

    • Principal Investigator: Carlo V Agostoni, Prof, Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico, Milano, Italy

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Cristiana Berti, Researcher, Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico
    ClinicalTrials.gov Identifier:
    NCT06052540
    Other Study ID Numbers:
    • 726_2021bis
    First Posted:
    Sep 25, 2023
    Last Update Posted:
    Sep 29, 2023
    Last Verified:
    Sep 1, 2023
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by Cristiana Berti, Researcher, Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico
    probiotic
    children
    respiratory infection
    Additional relevant MeSH terms:
    Infections
    Respiratory Tract Infections

    Study Results

    No Results Posted as of Sep 29, 2023