Friendly bacteria in a nasal spray might tame Kids' allergies

NCT ID NCT03449836

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Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

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Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Sep 01, 2026 · Last updated Sep 02, 2026 · Updated 1 time

Summary

This trial tests whether a nasal spray containing two probiotic bacteria strains can reduce allergy symptoms in children aged 6 to 12 with allergic rhinoconjunctivitis, a condition that causes sneezing, a runny nose, and itchy eyes. Researchers will compare the probiotic spray against a standard steroid nasal spray and a placebo. They will measure symptom scores and sleep quality to see if the probiotic offers a safe, non-drug option for managing allergies.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
A nasal spray containing two probiotic bacteria strains (Streptococcus salivarius 24SMBc and Streptococcus oralis 89a)
What this could lead to
If it works, this could offer a new, drug-free way to manage allergy symptoms in children and improve their sleep and daily life.
What could go wrong
This is a small trial, and the probiotic may not outperform standard treatments or placebo. The study also measures symptoms and sleep quality, which can vary widely.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 3

Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.

Participants

60 people

The number who actually took part.

Started

Mar 2018

Finished

Dec 2018

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

6 to 12 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * children aged 6-12 months with allergic rhinoconjunctivitis Exclusion Criteria: * concomitant presence of chronic pathologies, * malformations of the respiratory tract and facial cranium, * tumors, * neurological diseases, * metabolic pathologies, * cystic fibrosis, * immunodeficiencies, * history of epistaxis, * alteration of coagulation factors, * history of apnea, * ciliary dyskinesia, * treatment with topical drugs nasal steroids and / or oral anti-histaminics or antibiotic treatment in the 3 months prior to enrollment.

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Conditions

The condition(s) this trial relates to.

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Contacts and locations

Locations

  • University of Naples Federico II

    Naples, Italy

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