RecruitingNCT05794945

Optimizing Mastitis Identification and Treatment

OPTIMISTOptimizing Mastitis Identification and Treatment


Sponsor

University of Tromso

Enrollment

300 participants

Start Date

Oct 1, 2023

Study Type

OBSERVATIONAL

Conditions

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.


Eligibility

Sex: FEMALEMin Age: 18 YearsMax Age: 50 Years

Inclusion Criteria4

  • Pregnant mothers aged > 18
  • mothers must understand information given in Norwegian or English
  • participants must be willing to complete study questionnaires
  • participants must be willing to and provide biological samples

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Locations(2)

Tromsø municipality, health centre

Tromsø, Troms, Norway

UiT-The Arctic University of Norway

Tromsø, Norway

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NCT05794945