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
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