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Probiotic may restore vaccine power in Antibiotic-Treated babies

NCT ID NCT07189390

Disease control Sponsor: South Australian Health and Medical Research Institute Source: ClinicalTrials.gov ↗

What the study statuses mean

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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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 giving a probiotic (Infloran®) to infants who received antibiotics in their first month of life can improve their immune response to routine vaccines. Antibiotics can reduce helpful gut bacteria, which may weaken vaccine protection. The trial will compare antibody levels in 360 babies who receive either the probiotic or a placebo, with follow-up through 12 months of age.

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 360 people

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

Started

May 2026

Expected to finish

Oct 2029

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

Up to 28 days

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: 1. Infants administered antibiotics in the first 28 days of life. Infants must have documented direct antibiotic exposure - defined as having received at least 36 hours of antibiotic treatment in the neonatal period (the first 28 days after birth). 2. Gestational age ≥ 35 weeks. 3. Birth weight ≥ 2500g. 4. Mother aged at least 18 years and able and willing to provide written informed consent for themselves and their infant. 5. Parent/guardian agrees to not give any other probiotics to their infant prior to vaccination at 6 weeks, including any formula that contains probiotics. 6. Infant planning to receive all nationally approved vaccines during next 6 months. Exclusion Criteria: 1. Significant medical condition in either the mother or infant that, in the opinion of a medical investigator, may interfere with the study. 2. Infant had confirmed sepsis or other serious infection in the neonatal period. 3. Infants with known congenital diseases or who are immunocompromised or considered medically at risk (MAR). 4. Infant participating in another interventional trial during the trial period.

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As listed by the trial registrant

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

Antibiotic treatment Immunisation Immunity Infant, newborn Microbiome dysbiosis

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. 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

  • Flinders Medical Centre

    NOT_YET_RECRUITING

    Adelaide, South Australia, 5042, Australia

  • Women's and Children's Hospital, Adelaide

    RECRUITING

    Adelaide, South Australia, 5006, Australia

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