Probiotics may shorten Kids' colds, new study tests
NCT ID NCT07498127
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 Hide 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.
Get updates
Get notified about this study
Sign up to get updates when this study changes or when new studies for URTI are added.
Genom att skicka in godkänner du våra Användarvillkor
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.
-
The places running it
2 sites in 2 countries. The list below names each one and where it is.
-
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.
-
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
More trials for these conditions
Other studies related to the condition(s) this trial covers.