Upper Respiratory Tract Infection (URTI)NCT07835100
Probiotics for Sustained Health
A study testing Probiotic in people with Upper Respiratory Tract Infection (URTI), run by BioGaia AB at 2 sites in Italy.
Trial summary
This randomized, double-blind, placebo-controlled pilot study will evaluate the effect of a probiotic supplement on upper respiratory tract infections (URTIs) in children aged 4-18 years with a history of recurrent URTIs. Participants will be randomized to receive either probiotic drops or placebo drops. Read more about this study
- Who is it for?
- Ages 4 to 18 yearsHealthy volunteers can take part
- Conditions the study is for
- Upper Respiratory Tract Infection (URTI)
- What is being tested?
- Probiotic
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 70 participants
- Where
- 2 sitesItaly
- Study dates
- 25 Sep 2026to 30 Apr 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 4 to 18 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- Age 4 to18 years
- Male or female
- Healthy (no known chronic disease)
- At least 3 episodes of Upper Respiratory Tract Infection (pharyngitis and or tonsillitis, cold, rhinitis, sinusitis) in the previous year
- Written informed consent signed by both parents or caregivers
Who cannot join
- Use of antibiotics or probiotic products 2 weeks prior inclusion in the study
- Use of two or more consecutive months on antibiotics for respiratory infections on the last year
- Participation in another clinical trial
- Parents or caregivers unable to read, understand and follow the instructions
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Italy2 sites
AOU Università degli Studi della Campania "Luigi Vanvitelli"
Naples, 80138
Michele Miraglia del Giudice, MD, +390815665922, michele.miragliadelgiudice@unicampania.it
Università di Pisa
Pisa, 56126
Peroni Diego, +390502212111, diego.peroni@unipi.it
About this study
Official title: A Pilot Study; a Randomized Double-blind Placebo-controlled Study to Investigate a Probiotic Supplement on Symptoms of Upper Respiratory Tract Infections
This randomized, double-blind, placebo-controlled pilot study will evaluate the effect of a probiotic supplement on upper respiratory tract infections (URTIs) in children aged 4-18 years with a history of recurrent URTIs. Participants will be randomized to receive either probiotic drops or placebo drops. The primary objective is to assess the effect of the probiotic on the frequency of URTI episodes during the study period. Secondary objectives include evaluation of respiratory symptoms, medication use, healthcare visits, school absenteeism, recovery of the administered probiotic, and safety.
- Conditions
- Upper Respiratory Tract Infection (URTI)
- Being tested
- Probiotic, Placebo
- Keywords
- Probiotics, Upper Respiratory Tract Infection (URTI)
- 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.
ProbioticOther
Probiotic drops
PlaceboOther
Placebo drops
| Study group | Role | What they receive |
|---|---|---|
| Probiotic | Active comparator | Probiotic oil drops formulation. Administration twice daily. Receives: Other: Probiotic |
| Placebo | Placebo comparator | Placebo oil drops formulation. Administration twice daily. Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of episodes
Number of episodes presenting with three out of four of the following symptoms for three consecutive days: Fever, sore throat, nasal congestion or runny nose.
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Sep 2026
- Study start25 Sep 2026 (estimated)
- Primary completion30 Apr 2028 (estimated)
- Study completion30 Apr 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Upper Respiratory Tract Infection (URTI)Studies of the same condition, open and under way.
- 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 70 participants (estimated)
Sponsor and investigators
- Lead sponsor
- BioGaia AB
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07835100
- Sponsor's protocol ID
- CSUB0203
- Status last verified
- Sep 2026
- First submitted
- 17 Sep 2026
- Last updated
- 24 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Pilot Study; a Randomized Double-blind Placebo-controlled Study to Investigate a Probiotic Supplement on Symptoms of Upper Respiratory Tract Infections
- ClinicalTrials.gov ID
- NCT07835100
- Acronym / sponsor ID
- CSUB0203
- Conditions
- Upper Respiratory Tract Infection (URTI)
- Keywords
- Probiotics, Upper Respiratory Tract Infection (URTI)
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 70 participants (estimated)
- Lead sponsor
- BioGaia ABIndustry (pharma, biotech, devices)
- Study start
- 25 Sep 2026 (estimated)
- Primary completion
- 30 Apr 2028 (estimated)
- Study completion
- 30 Apr 2028 (estimated)
- First posted
- 22 Sep 2026 (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.
This randomized, double-blind, placebo-controlled pilot study will evaluate the effect of a probiotic supplement on upper respiratory tract infections (URTIs) in children aged 4-18 years with a history of recurrent URTIs. Participants will be randomized to receive either probiotic drops or placebo drops. The primary objective is to assess the effect of the probiotic on the frequency of URTI episodes during the study period. Secondary objectives include evaluation of respiratory symptoms, medication use, healthcare visits, school absenteeism, recovery of the administered probiotic, and safety.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Probiotic | Active comparator | Other: ProbioticProbiotic oil drops formulation. Administration twice daily. |
| Placebo | Placebo comparator | Other: PlaceboPlacebo oil drops formulation. Administration twice daily. |
Who may qualify
- Ages
- 4 to 18 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (5 listed)
- Age 4 to18 years
- Male or female
- Healthy (no known chronic disease)
- At least 3 episodes of Upper Respiratory Tract Infection (pharyngitis and or tonsillitis, cold, rhinitis, sinusitis) in the previous year
- Written informed consent signed by both parents or caregivers
Key exclusion criteria (4 listed)
- Use of antibiotics or probiotic products 2 weeks prior inclusion in the study
- Use of two or more consecutive months on antibiotics for respiratory infections on the last year
- Participation in another clinical trial
- Parents or caregivers unable to read, understand and follow the instructions
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 |
|---|---|---|
| ProbioticProbiotic drops | Other | Probiotic |
| PlaceboPlacebo drops | Other | Placebo |
Primary outcome
Number of episodes
Time frame: 3 months
Number of episodes presenting with three out of four of the following symptoms for three consecutive days: Fever, sore throat, nasal congestion or runny nose.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Sep 2026.
- Individual participant dataSharing planned: No
Related trials for Upper Respiratory Tract Infection (URTI)
Recruiting
RSV Burden in Outpatient and Hospital Settings
RSV Infection, Children, Only
RecruitingObservational study
POS-ARI-ER Observational Study of Acute Respiratory Infections
Acute Respiratory Infection, Acute Respiratory Tract Infection
Not yet recruiting
Vocxi Breath Analyzer Study in Pediatric Respiratory Infection
Acute Respiratory Illness, Viral Respiratory Infection
Not yet recruiting
Enhanced Telemedicine in Primary Care for Acute Respiratory Tract Infections Study
Acute Respiratory Tract Infection, Ear Infection
Not yet recruitingObservational study
Early Identification of Pathogens in Children With Respiratory Tract Infection by Mechanical Ventilation Using mNGS
VAP - Ventilator Associated Pneumonia
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.
AOU Università degli Studi della Campania "Luigi Vanvitelli"
Naples, Italy
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Probiotic in people with Upper Respiratory Tract Infection (URTI), run by BioGaia AB at 2 sites 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 5 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: opening soon, as of the sponsor's last update on 24 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of episodes (time frame: 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 24 Sep 2026.