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Mastitis PostpartumOPTIMISTNCT05794945

Optimizing Mastitis Identification and Treatment

An observational study of Mastitis Postpartum, run by University of Tromso at 2 sites in Norway.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 to 50 years, women only
Conditions the study is for
Mastitis Postpartum
How many people
300 participants
Where
2 sitesNorway
Study dates
1 Oct 2023to 1 Oct 2028
Phase
Observational
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 50 years
  • Women only
  • No healthy volunteers
  • Adult

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.

Who may be able to join

  • 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

Who cannot join

  • No exclusion criteria

Trial locations and contacts

2 sites in 1 country. Contact the study team or a site near you to ask about taking part.

Jorunn Pauline Cavanagh, PhD contact

40498490 ext. 47

pauline.cavanagh@uit.no

Claus Klingenberg, MD, PhD contact

91563167 ext. 47

claus.klingengerg@unn.no

Norway2 sites, 2 recruiting
  • Tromsø municipality, health centre

    Tromsø, Troms, 9019

    Recruiting
  • UiT-The Arctic University of Norway

    Tromsø, 9019

    Pauline Cavanagh, PhD, pauline.cavanagh@uit.no

    Beate Fossum Løland, MD,PhD

    Recruiting

Other trials in Norway

About this study

Official title: OPTIMISTOptimizing Mastitis Identification and Treatment

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:

Read more
  • 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.

Read the 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.

Keywords
Breast inflammation, Clinical mastitis, Sub-clinical mastitis
Medical subject headings
Mastitis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Study groups in NCT05794945
Study groupRoleWhat they receive
Breastfeeding mothersIn 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

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Determination of the microbial composition in human milk from mothers without mastitis by MALDTI-TOF and Illumina sequencing

    In order to investigate if there is a particular microbial composition of the human milk that leads to mastitis, the microbial composition in human milk from mothers without mastitis will be assessed. The investigators will collect milk samples from all enrolled mothers at day 6-7 after birth. Milk samples will be stored at -20 until further processing.

    Mothers who develop mastitis will be further sampled as described in outcome 2. Samples will be analyzed using culture dependent and culture independent methods. Following culturing of the milk samples, colonies will be analysed by Matrix-assisted laser desorption/ionization-time of flight (MALDI-TOF) to identify bacterial species. DNA will be isolated from the same milk sample.16S rRNA amplicon sequencing of DNA from milk samples will be performed using the Illumina technology, in order to get an overview of the total bacterial composition.

    Measured: 18 months

  2. Determination of the microbial composition in human milk from mothers at onset of mastitis by MALDTI-TOF and Illumina sequencing

    The investigators will investigate if the microbial composition in human milk changes at onset of mastitis. By analysing possible changes in microbial composition the investigators will assess if the mastitis symptoms are caused by microorganisms, or if the symptoms of mastitis are inflammatory. Milk samples will be collected by the mother at onset of mastitis, 24 hours after onset of symptoms and after resolution of symptoms. If the mastitis episode is treated with antibiotics, a new sample will be taken 24 hours after cessation of antibiotic treatment. Milk samples will be stored at -20 until further processing. Samples will be analyzed using culture dependent, and culture independent methods. Following culturing of the samples, colonies will be analysed by MALDI-TOF to identify bacterial species. 16S rRNA amplicon sequencing of DNA from milk samples will be performed using the Illumina technology, in order to get an overview of the total bacterial composition.

    Measured: 18 months

  3. Assessment of the microbial composition on nipples of mothers without mastitis

    It is no agreement on if mastitis causing bacteria originate from the breast nipple, or if they are part of the milk microbiome. We will sample the breast nipples in order to investigate if microorganisms colonizing the breast skin enter the mammary glands, and potentially cause mastitis. A skin swab of the nipple (both breasts) will be taken at day 6-7 after birth. Following culturing of the swab, bacterial colonies will be analysed by MALDI-TOF to identify bacterial species. The skin swabs will be collected at the same timepoints as collection of milk samples.

    Measured: 18 months

  4. Assessment of the microbial composition on nipples of mothers with mastitis

    It is no agreement on if mastitis causing bacteria originate from breast nipple, or if they are part of the milk microbiome. We will sample the breast nipples in order to investigate if microorganisms colonizing the breast skin enter the mammary glands, and potentially cause mastitis.

    When the mother experiences symptoms of mastitis the mother will collect a skin swab sample. Following culturing of the swab, bacterial colonies will be analysed by MALDI-TOF to identify bacterial species. The skin swabs will be collected at the same timepoints as collection of milk samples.The microbial composition on nipples of mothers with mastitis will also be compared to the nipple microflora of mothers without mastitis in order to see if there is a correlation between particular skin colonizing bacteria that cause mastitis.

    Measured: 18 months

  5. The concentration of immunological markers in milk from mothers without mastitis

    A milk sample will be collected at day 6-7 after birth, and the concentration of immunological markers will be assessed in the milk of mothers without mastitis. The concentration (pg/ml) of 8 immune factors, including innate immune factors (IL6, IFNγ, TNFα), acquired immune factors (IL2, IL4, IL10), chemokines (IL8), and growth factor (GMCSF), will be determined by magnetic bead-based multi- plex immunoassays, using a Bioplex 200 instrument (Bio-Rad, Hercules, CA, USA).

    Measured: 18 months

  6. The concentration of immunological markers in milk from mothers with mastitis

    In order to determine if there is an increase in the immunological markers present in milk from mothers with mastitis, milk samples will be collected at onset of mastitis symptoms and 24 hours after cessation of symptoms. If the mother requires antibiotic treatment , samples will be collected at onset of treatment and 24 hours after cessation of antibiotic treatment. The concentration (pg/ml) of 8 immune factors, including innate immune factors (IL6, IFNγ, TNFα), acquired immune factors (IL2, IL4, IL10), chemokines (IL8), and growth factor (GMCSF), will be determined by magnetic bead-based multi- plex immunoassays, using a Bioplex 200 instrument (Bio-Rad, Hercules, CA, USA).The investigators will assess if the concentration of immunological markers differs in bacterial mastitis and inflammatory mastitis.

    Measured: 18 months

  7. Mapping of mastitis symptoms by detailed Questionnaires

    The mothers will be asked to fill in a detailed questionnaire regarding breastfeeding practice and symptoms of mastitis.

    The questionnaire will accompany the collection of milk samples as described in outcome 1and 2.

    Measured: 18 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted3 Apr 2023
  2. Study start1 Oct 2023
  3. Primary completion1 Oct 2027 (estimated)
  4. Study completion1 Oct 2028 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
300 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05794945
Sponsor's protocol ID
2023/578416 (REK)
Other IDs
2023
Acronym
OPTIMIST
Status last verified
Mar 2026
First submitted
24 Feb 2023
Last updated
12 Mar 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes: Researchers will share questionnaires, Informed consent forms and protocol, after data is published.

Publications

  • 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.

    PubMed 32286139
  • 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.

    PubMed 35576513
  • 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.

    PubMed 34841537
  • 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.

    PubMed 35079053

Questions about this trial

What is this clinical trial studying?

An observational study of Mastitis Postpartum, run by University of Tromso at 2 sites in Norway.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 12 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in Norway. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Jorunn Pauline Cavanagh, PhD (40498490 ext. 47, pauline.cavanagh@uit.no), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Determination of the microbial composition in human milk from mothers without mastitis by MALDTI-TOF and Illumina sequencing (time frame: 18 months). The study lists 7 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05794945, which also lists 4 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Mar 2026.

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