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Breast milk secrets: Mom's health shapes Baby's gut and metabolism

NCT ID NCT05111990

Knowledge-focused Sponsor: University of Aarhus 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 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 looks at how a mother's health affects the makeup of her breast milk and how that, in turn, influences her baby's metabolism and gut bacteria. Researchers are collecting milk, blood, and urine samples from 168 mothers and their infants in Denmark. The goal is to better understand these connections, which could lead to improved breastfeeding guidance in the future.

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 successful, this could help us understand how a mother's health influences her breast milk and her baby's development, potentially guiding future nutrition recommendations.
What could go wrong
This is an observational study, not a treatment trial. It aims to gather knowledge, not test a therapy, so there is no direct benefit to participants. Results may not lead to immediate changes in practice.

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

168 people

The number who actually took part.

Started

Jun 2019

Expected to finish

Apr 2028

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

Residence in Aarhus area is necessary and Aarhus University Hospital has to be the place of giving birth. This is due to samples being collected by midwifes during labor and when study personnel collect samples in study participants' homes.

Ages

Children (under 18), adults (18 to 64) and older adults (65 and over)

Sex

Female participants only

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 related to mother: * Residing in Aarhus area * Above 18 years of age * BMI above 18.5 kg/m2 * Intention to breastfeed the first four to six months following birth * Be able to communicate in Danish Exclusion Criteria related to mother: * Smoking * Multiple gestation * Suffering from the following chronic diseases that demands medical treatment: diabetes mellitus, celiac disease, inflammatory bowel disease (Chrohn's disease or ulcerosa colitis) * Taking medicaments for irritable bowel syndrome * Taking medicine for metabolic disorders * Taking medicine for psychological disorders * Have had gastric bypass surgery * Planned caesarean section * Received antibiotics after week 12 in their pregnancy * Utilizing significant amount of infant formula following birth Inclusion Criteria related to infant: * Infants born after gestational age 37 weeks * Infants with a birth weight between 2500 g and 5000 g Exclusion Criteria related to infant: • Inborn errors of metabolism

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Conditions

The condition(s) this trial relates to.

Breast Milk Expression

As listed by the trial registrant

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

Breast milk collection Human milk microbiome Human milk/breastfeeding Infant gut microbiome

Contacts and locations

Locations

  • Aarhus University

    Aarhus, 8200, Denmark

More trials for these conditions

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