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Can gentle touch replace antibiotics for recurrent mastitis?

NCT ID NCT05132426

Disease control Sponsor: Western University of Health Sciences 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
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 Results may not be published yet.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 This study
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This status has not been confirmed recently, so it may be out of date.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 Aug 18, 2026 · Last updated Aug 19, 2026 · Updated 1 time

Summary

This trial tests whether osteopathic manipulative treatment (OMT) — a hands-on therapy using gentle tissue release — can treat recurrent mastitis without antibiotics and help prevent future episodes. Participants are women aged 18–50 with more than two episodes of lactational mastitis in the same breast within six months. The study compares OMT to a sham control, tracking recurrence rates, quality of life, and breastfeeding continuation.

What this could mean

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

Active substance
Osteopathic manipulative treatment (OMT), a hands-on therapy involving gentle tissue release techniques on the chest, neck, and breast area.
What this could lead to
If effective, OMT could offer a non-antibiotic option to treat recurrent mastitis and reduce future flare-ups, supporting continued breastfeeding.
What could go wrong
This is an early, small trial, and results may not confirm benefit. OMT is generally gentle, but risks include discomfort or lack of effect, and it may not replace antibiotics for severe infections.

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.

Started

Oct 2021

Finished

Dec 2022

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

18 to 50 years

Sex

Female participants only

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

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: * Between the ages of 18 and 50 years old. * Signed an informed consent form. * Clinical diagnosis of recurrent mastitis: more than 2 episodes of lactational mastitis in the same breast in a 6-month time period. * Evidence of somatic dysfunction upon undergoing an osteopathic structural exam. Exclusion Criteria: * Mammary abscesses. * Health problems related to pregnancy. * Inability to receive OMT due to open wounds, fractures, anuresis, necrotizing fasciitis, congestive heart failure, or unstable cardiac conditions. * Less than 18 years of age or more than 50 years of age.

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Conditions

The condition(s) this trial relates to.

mastitis

As listed by the trial registrant

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

Mastitis

Contacts and locations

Locations

  • Western University of Health Sciences

    Pomona, California, 91766, United States