Ignite Creation Date:
2024-05-06 @ 7:34 PM
Last Modification Date:
2024-10-26 @ 3:09 PM
Study NCT ID:
NCT06052540
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2023-09-29
First Post:
2023-09-19
Brief Title:
Probiotic Supplementation in Children Affected by Upper Respiratory Infections
Sponsor:
Fondazione IRCCS Ca Granda Ospedale Maggiore Policlinico
Organization:
Fondazione IRCCS Ca Granda Ospedale Maggiore Policlinico
Study Overview
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
Status:
ACTIVE_NOT_RECRUITING
Status Verified Date:
2023-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
PROBIOS2021
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
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
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None