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Breast milk secrets: stress and sleep may change What's in it

NCT ID NCT06393296

Knowledge-focused Sponsor: Mayo Clinic 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Aug 13, 2026 · Updated 2 times

Summary

This Mayo Clinic study looks at how a mother's stress, mood, sleep, and diet might affect levels of melatonin and an immune protein called sIgA in her breast milk. Researchers will follow 120 new mothers who are breastfeeding. The goal is to better understand these connections, not to test a treatment.

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 study could help identify lifestyle factors that improve breast milk composition, potentially guiding future recommendations for breastfeeding mothers.
What could go wrong
This is an observational study, not a treatment trial. It cannot prove cause and effect, and results may not apply to all mothers or lead to immediate changes in care.

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

88 people

The number who actually took part.

Started

Apr 2024

Finished

Jun 2026

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

New mothers receiving care at Mayo Clinic Health System in Eau Claire, Wisconsin.

Ages

18 years and older

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: * Possess a refrigerator with a freezer or a standalone freezer for sample storage at home. * Ability to be contacted by telephone. * Having internet access at home. * Being in the immediate (0-14 days) postpartum period. * Currently breastfeeding or planning to breastfeed, regardless of the type. Exclusion criteria: * Newborns with congenital malformations. * Newborns with birth weights less than 2,500g or greater than 4,000g. * Gestational age less than 37 completed weeks or greater than 42 completed weeks. * Mothers hospitalized in an intensive care unit (ICU). * Newborns hospitalized in the neonatal intensive care unit (NICU) or special care nursery (SCN). * Mothers using sleep aids (e.g., Benadryl, Unisom, Melatonin, Valerian). * Mothers currently being treated for pharmacologically treated mood and sleep disorders. * Mothers with acute infections longer than 7 days postpartum. Mothers will be withdrawn from study if antibiotics are taken between 7 and 14 days postpartum.

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Conditions

The condition(s) this trial relates to.

Breast Feeding

As listed by the trial registrant

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

Breastfeeding

Contacts and locations

Locations

  • Mayo Clinic Health System - Eau Claire

    Eau Claire, Wisconsin, 54703, United States

More trials for these conditions

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