Optimizing Mastitis Identification and Treatment

NCT05794945 · Status: RECRUITING · Type: OBSERVATIONAL · Enrollment: 300

Last updated 2026-03-12

No results posted yet for this study

Summary

The goal of this observational study is to gain more information about the aetiology and progression of mastitis and breast inflammation, in order to develop evidence-based clinical guidelines and treatment plans, especially concerning judicious use of antibiotics.

The main questions it aims to answer are:

* Do clinical symptoms differ between inflammatory and infectious mastitis?
* What is the microbial composition in human milk, and does it change before, during, and after episodes of mastitis?
* Does the bacterial composition change due to antibiotic treatment?
* Are all mastitis episodes treated with antibiotics bacterial mastitis?
* Do mothers with recurrent mastitis have a distinct microbial composition?
* Are there immunological markers that can differentiate between bacterial and inflammatory mastitis?

Researchers will compare breastfeeding women with and without mastitis to see if the microbiological composition in milk and on the skin of the breast and breast nipple differs.

Conditions

  • Mastitis Postpartum

Sponsors & Collaborators

  • Norwegian Institute of Public Health

    collaborator OTHER_GOV
  • The University of Western Australia

    collaborator OTHER
  • Helse Nord

    collaborator INDUSTRY
  • University of Tromso

    lead OTHER

Principal Investigators

  • Jorunn Pauline Cavanagh, PhD · The Arctic university of Norway-UiT

Eligibility

Min Age
18 Years
Max Age
50 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-10-01
Primary Completion
2027-10-01
Completion
2028-10-01

Countries

  • Norway

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05794945 on ClinicalTrials.gov