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Probiotic powder could keep kids Cold-Free this winter

NCT ID NCT07154992

Prevention Sponsor: Bioithas SL 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 25, 2026 · Last updated Jun 26, 2026 · Updated 1 time

Summary

This study tests whether a daily probiotic supplement (Lacticaseibacillus rhamnosus CRL1505) can prevent upper respiratory infections like colds and flu in healthy children aged 3 to 12. Over 268 kids will take either the probiotic or a placebo for 12 weeks, then be followed for another 16 weeks. Researchers will compare how many children get sick and how often.

What this could mean

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

Active substance
Lacticaseibacillus rhamnosus CRL1505 probiotic
What this could lead to
If it works, this could offer a simple, safe way to reduce colds and flu in children.
What could go wrong
This is a small, early-stage trial. The probiotic may not reduce infections more than a placebo, and results may not apply to all children.

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

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

About 268 people

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

Started

Dec 2024

Expected to finish

Apr 2027

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

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

Ages

3 to 12 years

Sex

Anyone

Healthy volunteers

Accepted

You do not need to have the condition being studied to take part.

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: * Healthy children aged 3 to 12 years. * Signed Informed Consent by the parents Exclusion Criteria: * Chronic pathological conditions, such as chronic respiratory diseases (asthma, chronic bronchitis, etc.), chronic heart diseases, chronic neurological diseases (psychomotor impairment, etc.), chronic liver diseases, chronic kidney diseases, chronic gastrointestinal diseases, hematological disorders, etc., or any other disease or condition that the investigator considers to significantly affect the health of the participating child. * Metabolic disorders, such as diabetes mellitus, obesity, etc. * Immunodeficiency, including HIV infection, chronic corticosteroid treatment, etc. * Nasal polyps, nasal ulcers, or other conditions that may cause nasal obstruction. * Regular use of medications or dietary supplements that may influence the study outcomes (immunosuppressants/immunostimulants, including echinacea supplements, analgesics, anti-inflammatory drugs, antitussives/expectorants, flu preparations, decongestants, antibiotics, antihistamines, probiotics, etc.) within the 4 weeks prior to the start of the clinical trial.

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Conditions

The condition(s) this trial relates to.

respiratory tract infectious disorder prevention target

As listed by the trial registrant

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

Prevention Upper respiratory tract infection

How to take part

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

  1. The places running it

    1 site. 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

  • MiBioPath Research Group (UCAM)

    RECRUITING

    Murcia, Spain

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