Actively Recruiting

Age: 18Years - 50Years
FEMALE
NCT05794945

Optimizing Mastitis Identification and Treatment

Led by University of Tromso · Updated on 2026-03-12

300

Participants Needed

2

Research Sites

261 weeks

Total Duration

On this page

Sponsors

U

University of Tromso

Lead Sponsor

N

Norwegian Institute of Public Health

Collaborating Sponsor

AI-Summary

What this Trial Is About

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

Official Title

Optimizing Mastitis Identification and Treatment

Who Can Participate

Age: 18Years - 50Years
FEMALE

Eligibility Criteria

Eligible

You may qualify if you...

  • Pregnant mothers aged > 18
  • Ability to understand information in Norwegian or English
  • Willingness to complete study questionnaires
  • Willingness to provide biological samples
Not Eligible

You will not qualify if you...

History of severe allergic reactions to study medication Currently pregnant or breastfeeding Recent participation in another clinical trial within the last 30 days Presence of uncontrolled medical conditions that could affect safety

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Trial Site Locations

Total: 2 locations

1

Tromsø municipality, health centre

Tromsø, Troms, Norway, 9019

Actively Recruiting

2

UiT-The Arctic University of Norway

Tromsø, Norway, 9019

Actively Recruiting

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Research Team

J

Jorunn Pauline Cavanagh, PhD

CONTACT

C

Claus Klingenberg, MD, PhD

CONTACT

How is the study designed?

Study Type

OBSERVATIONAL

Masking

N/A

Allocation

N/A

Model

N/A

Primary Purpose

N/A

Number of Arms

1

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