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Could probiotics cut Kids' colds? new trial tests antrrix in 120 children

NCT ID NCT07297966

Disease control Sponsor: Min-Tze LIONG Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
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
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 Results may not be published yet.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

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 24, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This study tests whether a daily probiotic supplement (Antrrix) can reduce the frequency and severity of respiratory infections in children under 6 who get sick often. Over 8 weeks, 120 kids will receive either the probiotic or a placebo. Researchers will track symptoms and quality of life, and also analyze gut bacteria to understand how the probiotic might work.

What this could mean

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

Active substance
Antrrix probiotics (Lactobacillus rhamnosus CRL1505 and Bifidobacterium brevis M-16V)
What this could lead to
If it works, this could point toward a simple probiotic supplement to help young children have fewer and less severe respiratory infections.
What could go wrong
This is an early phase 2 trial with only 120 children, so results may not apply to all kids. Probiotics may not work for everyone, and the study is too small to confirm safety or effectiveness.

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 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

About 120 people

The number the study aims to enrol. It can still change while the study runs.

Started

May 2025

Expected to finish

Jun 2026

An estimate. End dates often move.

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

1 day to 6 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: * Age \< 6 years, gender not limited; * Meets the clinical diagnostic criteria for recurrent respiratory tract infections (Clinical Diagnosis and Treatment Pathway for Recurrent Respiratory Tract Infections in Children (2022 Edition) 10 ); * Parents or other legal guardians of the child fully understand the trial and voluntarily sign informed consent forms before the start of any research procedure; * Willing to discontinue the use of other probiotics during the trial; * Agree to the collection of fecal biological samples during this trial. Exclusion Criteria: * Those deemed by the investigator to have poor compliance or be unsuitable for participation; * Allergic to the investigational product and its components; * Allergic to respiratory tract infection drugs and their components; * Respiratory infections caused by underlying diseases such as primary immunodeficiency diseases, acquired immunodeficiency syndrome (ADRS), congenital airway malformations, congenital heart disease, gastroesophageal reflux disease (GERD), and pulmonary dysplasia; * Patients with severe malnutrition, rickets, and severe primary diseases of the heart, brain, liver, kidney, and hematopoietic systems; * Use probiotic preparations, antibiotics, immunostimulants, or immunosuppressants 4 weeks before participating in the experiment.

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Conditions

The condition(s) this trial relates to.

respiratory tract infectious disorder

As listed by the trial registrant

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

Recurrent respiratory tract infections

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    2 sites in 2 countries. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Universiti Sains Malaysia

    NOT_YET_RECRUITING

    George Town, Pulau Pinang, 11800, Malaysia

  • Xinyi City People's Hospital

    RECRUITING

    Xingyi, Guangdong, China

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