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Probiotics may shorten Kids' colds, new study tests

NCT ID NCT07498127

What the study statuses mean

This study's is highlighted.

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 This study
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 27, 2026 · Last updated Jun 27, 2026

Summary

This study tests whether a mix of two probiotics (Lactobacillus rhamnosus and Bifidobacterium breve) can reduce the severity and duration of cold symptoms in children aged 3 months to 6 years. 120 children with mild to moderate upper respiratory infections will receive either the probiotics or a placebo for 14 days. Researchers will track symptoms, quality of life, and gut health to see if the probiotics help.

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

Feb 2026

Expected to finish

Dec 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

3 months 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: * Children aged 3 months to 6 years, regardless of sex. * Meet the clinical diagnostic criteria for upper respiratory tract infection, including but not limited to cough, rhinorrhea, nasal congestion, sore throat, and fever. * Assessed by a clinician as having mild or moderate URTI, not requiring antibiotics or other systemic prescription medications, and suitable for observation and/or symptomatic management. * Willing to discontinue other probiotics or supplements during the study period, except for the study product provided by the investigators. * Agree to complete questionnaires and provide fecal biological samples during the study period. * The child's parent(s) or legal guardian(s) are fully informed about the trial and voluntarily sign the written informed consent form before any study procedures begin. Exclusion Criteria: * Severe URTI as judged by the clinician, or symptoms severe enough to require antibiotics, corticosteroids, nebulized steroids/bronchodilators, or other systemic prescription medications, including suspected or confirmed bacterial infections such as bacterial tonsillitis, bacterial sinusitis, or acute suppurative otitis media. * Acute lower respiratory tract infections, such as acute bronchitis, acute laryngitis/laryngospasm, or pneumonia. * Respiratory tract infections secondary to underlying diseases, including primary immunodeficiency, acquired immunodeficiency syndrome, congenital airway malformation, congenital heart disease, gastroesophageal reflux, or abnormal lung development. * Severe malnutrition. * Severe chronic diseases, including severe asthma or other chronic respiratory diseases, chronic hepatitis or other liver diseases affecting liver function, renal insufficiency or other severe kidney diseases, neurological diseases such as epilepsy or neurodevelopmental disorders, and major genetic diseases such as chromosomal abnormalities or monogenic disorders. * History of epilepsy or febrile convulsions. * Planned vaccination during the trial period. * Severe infection, severe trauma, or history of medium-to-major surgery within the past month, as judged by the investigator. * Participation in other clinical intervention studies involving drugs, dietary supplements, probiotics, or prebiotics within the past 3 months. * Known allergy to any component of the probiotic product. * Any other condition that, in the opinion of the investigator, makes the participant unsuitable for this clinical study.

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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.

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

    The full official record for this study. This one lists no contact details, but it is the first place any would appear.

    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

  • Shanghai Sixth People's Hospital

    Xuhui, Shanghai Municipality, 201306, China

  • Universiti Sains Malaysia

    Pulau Pinang, Pulau Pinang, 11800, Malaysia

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