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Antibiotics in infancy could weaken vaccine protection, study suggests

NCT ID NCT06079606

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
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 This study
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 follows 200 healthy infants in Iceland to see if antibiotics given early in life change how well their bodies respond to routine vaccines, including the rotavirus vaccine. Researchers will measure antibodies in saliva and blood, and also analyze stool samples to check the gut microbiome. The goal is to understand whether antibiotics might interfere with vaccine effectiveness.

What this could mean

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

What this could lead to
If this study finds a link, it could help doctors understand how antibiotics might weaken vaccine protection in infants, leading to better vaccination strategies.
What could go wrong
This is an observational study, not a treatment trial. It can show a connection but cannot prove cause and effect. Results may not apply to all populations.

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.

Participants

About 200 people

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

Started

Sep 2022

Expected to finish

Dec 2027

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.

Who is studied

* Group A: In total 50 term children born in Iceland during the time period 2022-2023, delivered with elective caesarean section (their mothers received intra-operative antibiotics). * Group B: In total 50 term children born in Iceland during the time period 2022-2023, delivered vaginally and their mothers received intra-partum antibiotics. * Group C: In total 50 term children born in Iceland during the time period 2022-2023, delivered vaginally and received systemic antibiotics during the first week of life for at least 48 hours. * Control group (Group D): In total 50 term children born in Iceland during the time period 2022-2023, delivered vaginally and received no systemic antibiotics at the time of recruitment.

Ages

Up to 6 weeks

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: * All term children born in Iceland from 2022-2023 Exclusion Criteria: * Children born with emergency caesarean section * Children born before 36 weeks of gestation * Children diagnosed with primary or secondary immunodeficiency * Use of immunosuppressive drugs at recruitment or during the follow up period (excluding inhaled corticosteroids and short term oral corticosteroids (\<3 consecutive days). * Children with chromosomal, genetic or other congenital diseases or abnormalities * Children with severe, chronic diseases or disabilities * Informed consent not signed by parents

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As listed by the trial registrant

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

Contacts and locations

Locations

  • Landspitali University Hospital

    Reykjavik, 101, Iceland

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