Probiotic Supplementation in Children Affected by Upper Respiratory Infections (NCT06052540) | Clinical Trial Compass
UnknownNot Applicable
Probiotic Supplementation in Children Affected by Upper Respiratory Infections
Italy128 participantsStarted 2021-09-01
Plain-language 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).
Who can participate
Age range
29 Days – 4 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Mean duration of fever in days by measuring body temperature
Timeframe: Approximatively 7 days
Trial details
NCT IDNCT06052540
SponsorFondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico