Optimizing Mastitis Identification and Treatment (OPTIMIST)

University of Tromso (UiT)

Status: Enrolling

Conditions: Mastitis Postpartum

Study type: Observational

Funder types: Other; Industry

Identifiers

NCT05794945

2023/578416 (REK)

Details and patient eligibility

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.

Full description

Mastitis (breast inflammation) is experienced by up to one-fifth of all breastfeeding mothers. Mastitis is a painful condition and a leading cause of early weaning, an undesired outcome with potentially negative implications for both mother and baby. Empirical evidence explaining the aetiology of mastitis is lacking; thus the definitions and treatment of mastitis is conflicting. The recent mechanobiological model proposes that the mechanical forces of lactation, especially at the onset of milk production, can cause damage to the mammary tissue, which induces an inflammatory response. Concurrently a growing amount of evidence shows that bacteria previously written off as contaminants have a role in mastitis which has been overlooked. The dynamics between the mechanobiological model and bacterial colonization have not yet been investigated. To fill this knowledge gap, researchers will conduct a longitudinal study collecting milk samples and questionnaires during the breastfeeding period with a particular emphasis on mastitis. Milk and skin swab samples will be used for culture dependent and culture independent assessment of the microbial composition in mastitis, and will be compared to the composition found in mothers without mastitis.

The main objective of this clinical study is to gather empirical data to provide an evidence-based update to the clinical guidelines for mastitis diagnosis and care. This will provide a foundation for improving the treatment and prevention of mastitis, with better outcomes for mothers and newborns.

Enrollment: 500 estimated patients

Sex: Female

Ages: 18 to 45 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• 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

Exclusion criteria

• No exclusion criteria

Trial design

500 participants in 1 patient group

Breastfeeding mothers

Description:

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