Optimizing Mastitis Identification and Treatment

Recruiting now

Conditions studied: Mastitis Postpartum

In brief

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.

Key facts

Study ID

NCT05794945

Run by

University of Tromso

People needed

300

Starts

2023-10-01

Expected to finish

2028-10-01

Last updated by the study team

2026-03-12

Who can join

Age: 18 and older, up to 50. Sex: female. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• No exclusion criteria

Where it is running

• Tromsø municipality, health centre — Tromsø, Troms, Norway (enrolling)
• UiT-The Arctic University of Norway — Tromsø, Norway (enrolling)

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.