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Could a daily probiotic shield babies from allergies?

NCT ID NCT07490587

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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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

Summary

This study tests whether a daily probiotic supplement (Bifidobacterium lactis XLTG11) can lower the chance of allergies in healthy infants under 3 years old who are at higher risk. Over 180 days, researchers will track allergy symptoms and analyze gut bacteria changes. The goal is to see if this simple intervention can support immune development and reduce allergic reactions.

What this could mean

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

Active substance
Bifidobacterium animalis subsp. lactis XLTG11 probiotic
What this could lead to
If it works, this could point toward a simple daily supplement to help prevent allergies in infants at high risk.
What could go wrong
This is an early phase 2 trial, so results are not yet proven. The probiotic may not reduce allergies, and individual responses can vary.

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 366 people

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

Started

Jan 2024

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

0 to 36 months

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: * Term infants are 37≤ gestational age \< 42 weeks, and the birth weight is between 2500g and 4000g (only applicable to 0\~12 months old) * Breastfed or mixed-fed healthy infants and young children, aged 0\~3 (inclusive) years old, gender is not limited * The allergy risk score calculated by the Infant Allergy Risk Assessment Table is ≥6(Refer to the National Center for Women and Children's Health, Chinese Center for Disease Control and Prevention: Investigation and Research on Allergy Symptoms and Risk Factors in Infants and Young Children) * Family primary guardians agree to collect fecal samples of infants and young children during this study * Have not used antibiotics in the past month * Have not used probiotics in the past three months * Family primary guardians committed not to add additional Bifidobacterium dietary supplements to infants and young children during the intervention period * The guardians of the enrolled subjects agree to participate in this interventional study and sign a written informed consent form, and are able to understand and fill in forms such as infant diaries as required * Signed informed consent and willing to follow up at the time specified in the trial Exclusion Criteria: * The mother of the infant has a history of diabetes, hepatitis B, HIV and other infectious diseases * Clinicians diagnosed with allergic diseases (including but not limited to eczema, asthma, allergic proctocolitis, allergic rhinitis, hay fever, etc.) at the time of enrollment of infants and young children * Infants and young children who are known to be allergic to the ingredients of probiotic products * In the opinion of the investigator, the subject has other reasons that make it unsuitable to participate in this clinical study

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Conditions

The condition(s) this trial relates to.

allergic disease prevention target

As listed by the trial registrant

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

Healthy children

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

  • Shanghai Sixth People's Hospital

    RECRUITING

    Pudong, Shanghai Municipality, 201306, China

  • Universiti Sains Malaysia

    NOT_YET_RECRUITING

    Pulau Pinang, Pulau Pinang, 11800, Malaysia

More trials for these conditions

Other studies related to the condition(s) this trial covers.