Breast Infection Clinical Trials

Find Breast Infection Clinical Trials Near You

OPTIMISTOptimizing Mastitis Identification and Treatment

Status: Recruiting
Location: See all (2) locations...
Study Type: Observational
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
Participation Requirements
Sex: Female
Minimum Age: 18
Maximum Age: 50
Healthy Volunteers: f
View:

• 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

Locations
Other Locations
Norway
Tromsø municipality, health centre
RECRUITING
Tromsø
UiT-The Arctic University of Norway
RECRUITING
Tromsø
Contact Information
Primary
Jorunn Pauline Cavanagh, PhD
pauline.cavanagh@uit.no
40498490
Backup
Claus Klingenberg, MD, PhD
claus.klingengerg@unn.no
91563167
Time Frame
Start Date: 2023-10-01
Estimated Completion Date: 2028-10-01
Participants
Target number of participants: 300
Treatments
Breastfeeding mothers
In this study breastfeeding mothers will be included. Samples will be collected from breast-feeding mothers experiencing mastitis Samples will be collected from breast-feeding mothers after the mastitis episode is resolved Breastfeeding mothers will be sampled at each mastitis episode, and with the final sample collected after a maximum of 12 months
Related Therapeutic Areas
Sponsors
Collaborators: The University of Western Australia, Helse Nord, Norwegian Institute of Public Health
Leads: University of Tromso

This content was sourced from clinicaltrials.gov