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Breast milk from donors may help Antibiotic-Exposed Newborns' gut health

NCT ID NCT05815433

Knowledge-focused Sponsor: University of Calgary Source: ClinicalTrials.gov ↗

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
Running, but no longer taking on new participants.
Completed This study
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 pilot study looked at whether giving donor human milk instead of formula to full-term babies whose mothers received antibiotics during labor could improve their gut bacteria and health. The study included 105 infants born vaginally at full term. Researchers compared the babies' gut microbiomes, sleep, growth, and their mothers' well-being between the two feeding groups.

What this could mean

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

Active substance
donor human milk
What this could lead to
If donor milk is shown to improve gut bacteria balance and health in antibiotic-exposed infants, it could support broader use of donor milk over formula for these babies.
What could go wrong
This is a small pilot study with only 105 participants, so results may not be conclusive. The study is completed but not yet published, and findings may not apply to all infants or settings.

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

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

105 people

The number who actually took part.

Started

Sep 2023

Finished

Dec 2025

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

37 weeks and older

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: * Gestation greater than 37 weeks (full-term) * Completion of antibiotic protocol for GBS during labour * Vaginal delivery * Intending on breastfeeding * Consent for infant to receive DHM * Working understanding (proficient in reading and understanding) English * Mother has provided signed and dated informed consent and authorization to use protected health information, as required by national and local regulations. * In the investigator's opinion, the subject mother understands and can comply with protocol requirements, instructions, and protocol-stated restrictions, and is likely to complete the study as planned. Exclusion Criteria: * Diagnosed with clinically significant major congenital malformation that will interfere with breastfeeding or growth * No intention to breastfeed * Receiving extended courses of antibiotics (beyond that of the IAP in labour)

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Conditions

The condition(s) this trial relates to.

Breast Feeding infectious disease postpartum depression

As listed by the trial registrant

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

Microbial colonization

Contacts and locations

Locations

  • Rockyview General Hospital

    Calgary, Alberta, T2V 1P9, Canada

More trials for these conditions

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