Upper Respiratory Tract InfectionPROBIOS2021NCT06052540
Probiotic Supplementation in Children Affected by Upper Respiratory Infections
A study testing Probiotic supplement in people with Upper Respiratory Tract Infection, run by Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico at 1 site in Italy.
Trial 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. Read more about this study
- Who is it for?
- Ages 29 days to 4 years
- Conditions the study is for
- Upper Respiratory Tract Infection
- What is being tested?
- Probiotic supplement
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 128 participants
- Where
- 1 siteItaly
- Study dates
- 1 Sep 2021to 30 Jun 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 29 days to 4 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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
Who cannot join
- Presence of pathologies associated with immunosuppression or ongoing immunosuppressant treatments
- Hospitalisation/hospitalisation
- Diarrhea at enrollment
- No signed informed consent
Trial locations and contacts
1 site in 1 country.
Italy1 site
Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico
Milan, 20122
About this study
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
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:
Read more
- 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).
- Conditions
- Upper Respiratory Tract Infection
- Being tested
- Probiotic supplement, Placebo
- Keywords
- probiotic, children, respiratory infection
- Medical subject headings
- Respiratory Tract Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Probiotic supplementDietary supplement
Also called Ofmom SynterAct BIMBI
- 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.
PlaceboDietary supplement
- Drops: Medium Chain Triglycerides, vegetal oil, E471, and maltodextrin
- Stick: Maltodextrin.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Dietary Supplement: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: Approximatively 7 days
Secondary outcomes (3)
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
Measured: 1 year
Gastrointestinal symptoms
Evaluation of the gastrointestinal symptoms by interview
Measured: Approximatively 7 days
Adverse events
Evaluation of differences in clinical effects in subjects with or without antibiotics collected by interview
Measured: Approximatively 15 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Sep 2023
- Study start1 Sep 2021
- Primary completion30 Jun 2023
- Study completion30 Jun 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Upper Respiratory Tract InfectionStudies of the same condition, open and under way.
- More trials run by Fondazione IRCCS Ca' Granda, Ospedale Maggiore PoliclinicoThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 128 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Cristiana Berti, Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico
- Investigators
- Carlo V Agostoni, Prof, Principal investigator, Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico, Milano, Italy
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06052540
- Sponsor's protocol ID
- 726_2021bis
- Acronym
- PROBIOS2021
- Status last verified
- Sep 2023
- First submitted
- 19 Sep 2023
- Last updated
- 29 Sep 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 40085083
Study at a glance
From the registry record, last updated by the sponsor on 29 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT06052540
- Acronym / sponsor ID
- PROBIOS2021 / 726_2021bis
- Conditions
- Upper Respiratory Tract Infection
- Keywords
- probiotic, children, respiratory infection
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 128 participants (actual)
- Lead sponsor
- Fondazione IRCCS Ca' Granda, Ospedale Maggiore PoliclinicoUniversity, hospital or other
- Study start
- 1 Sep 2021 (actual)
- Primary completion
- 30 Jun 2023 (actual)
- Study completion
- 30 Jun 2024 (estimated)
- First posted
- 25 Sep 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Probiotics | Active comparator | Dietary Supplement: Probiotic supplementProbiotic supplement: Mix of probiotic strails. Administration: 1 stick per day or 5 drops per day. Study duration for each patient: 14 days. |
| Placebo | Placebo comparator | Dietary Supplement: PlaceboPlacebo: Medium Chain Triglycerides. Administration: 1 stick per day or 5 drops per day. Study duration for each patient: 14 days. |
Who may qualify
- Ages
- 29 days to 4 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (4 listed)
- Presence of pathologies associated with immunosuppression or ongoing immunosuppressant treatments
- Hospitalisation/hospitalisation
- Diarrhea at enrollment
- No signed informed consent
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Probiotic supplementAlso: Ofmom SynterAct BIMBI* 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. | Dietary supplement | Probiotics |
| Placebo* Drops: Medium Chain Triglycerides, vegetal oil, E471, and maltodextrin * Stick: Maltodextrin. | Dietary supplement | Placebo |
Primary outcome
Mean duration of fever in days by measuring body temperature
Time frame: 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
3 secondary outcomes
Mean change in gut microbial composition by measuring gut microbiota characterization in fecal samples
Time frame: 1 year
Gastrointestinal symptoms
Time frame: Approximatively 7 days
Adverse events
Time frame: Approximatively 15 days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Sep 2023.
- Derived from this study: PubMed 40085083Bettocchi 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Carlo V Agostoni, Prof principal investigator
Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico, Milano, Italy
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Probiotic supplement in people with Upper Respiratory Tract Infection, run by Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 29 Sep 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Mean duration of fever in days by measuring body temperature (time frame: Approximatively 7 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06052540, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Sep 2023.