Clinical trial NCT05794945: Optimizing Mastitis Identification and Treatment
Official title: OPTIMISTOptimizing Mastitis Identification and Treatment
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Mastitis Postpartum
Keywords: Breast inflammation
Clinical mastitis
Sub-clinical mastitis
Lead sponsor: University of Tromso
Sponsor class: OTHER
Collaborators: name: Norwegian Institute of Public Health
name: The University of Western Australia
name: Helse Nord
First posted: 2023-04-03
Enrollment: 500
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Pregnant mothers aged \> 18 years planning to give birth at University Hospital Noth Norway (UNN), with the intention to breastfeed and with an address in Tromsø municipality.

Brief 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.

Detailed 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.

Eligibility criteria: 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

Primary outcomes:
measure: Determination of the microbial composition in human milk from mothers without mastitis by MALDTI-TOF and Illumina sequencing
timeFrame: 18 months
measure: Determination of the microbial composition in human milk from mothers at onset of mastitis by MALDTI-TOF and Illumina sequencing
timeFrame: 18 months
measure: Assessment of the microbial composition on nipples of mothers without mastitis
timeFrame: 18 months
measure: Assessment of the microbial composition on nipples of mothers with mastitis
timeFrame: 18 months
measure: The concentration of immunological markers in milk from mothers without mastitis
timeFrame: 18 months
measure: The concentration of immunological markers in milk from mothers with mastitis
timeFrame: 18 months
measure: Mapping of mastitis symptoms by detailed Questionnaires
timeFrame: 18 months
Secondary outcomes:
Other outcomes:
Locations:
city: Tromsø
country: Norway
facility: Tromsø municipality, health centre
state: Troms
city: Tromsø
country: Norway
facility: UiT-The Arctic University of Norway
Study officials:
affiliation: The Arctic university of Norway-UiT
name: Jorunn Pauline Cavanagh, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Wilson E, Woodd SL, Benova L. Incidence of and Risk Factors for Lactational Mastitis: A Systematic Review. J Hum Lact. 2020 Nov;36(4):673-686. doi: 10.1177/0890334420907898. Epub 2020 Apr 14.
citation: Mitchell KB, Johnson HM, Rodriguez JM, Eglash A, Scherzinger C, Zakarija-Grkovic I, Cash KW, Berens P, Miller B; Academy of Breastfeeding Medicine. Academy of Breastfeeding Medicine Clinical Protocol #36: The Mastitis Spectrum, Revised 2022. Breastfeed Med. 2022 May;17(5):360-376. doi: 10.1089/bfm.2022.29207.kbm.
citation: Grzeskowiak LE, Saha MR, Ingman WV, Nordeng H, Ystrom E, Amir LH. Incidence, antibiotic treatment and outcomes of lactational mastitis: Findings from The Norwegian Mother, Father and Child Cohort Study (MoBa). Paediatr Perinat Epidemiol. 2022 Mar;36(2):254-263. doi: 10.1111/ppe.12824. Epub 2021 Nov 28.
citation: Castro I, Garcia-Carral C, Furst A, Khwajazada S, Garcia J, Arroyo R, Ruiz L, Rodriguez JM, Bode L, Fernandez L. Interactions between human milk oligosaccharides, microbiota and immune factors in milk of women with and without mastitis. Sci Rep. 2022 Jan 25;12(1):1367. doi: 10.1038/s41598-022-05250-7.