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Gut Microbiota and Nonpuerperal Mastitis

Alterations in the Gut Microbiota and Metabolite Profiles of Nonpuerperal Mastitis Patients

Status
UNKNOWN
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT05051215
Enrollment
100
Registered
2021-09-21
Start date
2021-08-15
Completion date
2024-08-15
Last updated
2021-09-21

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Microbiota

Keywords

Gut Microbiota, Nonpuerperal mastitis, Plasma cell mastitis, Granulomatous mastitis, Metabonomics

Brief summary

Nonpuerperal mastitis (NPM), mainly including Plasma cell mastitis (PCM) and Granulomatous mastitis (GM), which clinical presentation is an accessible and painful breast mass accompanied by skin redness and swelling, nipple retraction and fistula formation . Much progress has been made in exploring the etiology and pathogenesis of NPM, while the exact etiology remains unknown, NPM is thought to arise from interactions between genetic susceptibility factors, epigenetic effects, and various environmental factors. While microbiota as an environment factor to some inflammatory and autoimmune diseases accept widespread attention, if gut microbiota also as a risk factor for NPM, it is worthy to be considered.

Detailed description

NPM is common in young women of reproductive age with a history of lactation and childbearing . The main clinical presentation is an accessible and painful breast mass accompanied by skin redness and swelling, nipple retraction and fistula formation . The imaging of NPM is not specific, with NPM mimicking breast cancer in imaging . NPM etiology is associated with several factors, such as autoimmunity, bacterial infections , estrogen and progesterone imbalance , and hyperprolactinemia . In recent years, NPM has become a common benign breast disease, especially in the Mediterranean region and developing countries in Asia, such as China . Currently, the associations between bacterial infections and NPM are among the important issues attracting research interest. This study tried to reveal the roles of gut microbiota in NPM. Further understanding of the roles of gut microbiota in this disease may lead to the development of methods for personalized therapy.

Interventions

None listed

Sponsors

First Affiliated Hospital of Harbin Medical University
Lead SponsorOTHER

Study design

Observational model
CASE_CONTROL
Time perspective
CROSS_SECTIONAL

Eligibility

Sex/Gender
FEMALE
Age
18 Years to 65 Years
Healthy volunteers
Yes

Inclusion criteria

* Aged 18 to 65 years * Patients of NPM

Exclusion criteria

* Pregnancy * Lactation * Cigarette smoking * Alcohol addiction * Hypertension * Diabetes mellitus * Lipid dysregulation * BMI \> 27 \<18.5 * Recent (\< 1 months prior) use of antibiotics, probiotics, prebiotics, synbiotic, hormonal medication, laxatives, proton pump inhibitors, insulin sensitizers or Chinese herbal medicine * History of disease with an autoimmune component, such as multiple sclerosis(MS), rheumatoid arthritis, irritable bowel disease(IBS), or irritable bowel syndrome(IBD) * History of malignancy or any gastrointestinal tract surgery

Design outcomes

Primary

MeasureTime frameDescription
Microbial profiling of Nonpuerperal Mastitis patients and Healthy controlsBaseline16S ribosomal ribonucleic acid(rRNA) gene sequencing technique and illumina MiSeq platform were applied to investigate the difference of gut microbiota richness, diversity and composition between NPM and Healthy controls,and revealing the special gut microbiota profiling data of NPM.

Secondary

MeasureTime frameDescription
Metabolic profiling of Nonpuerperal Mastitis patients and Healthy controlsBaselineFecal samples were prepared for Ultra-performance liquid chromatography quadrupole time of-flight tandem mass spectrometry (UPLC-Q-TOF/MS) to investigate the difference metabolites and metabolic pathway between NPM and Healthy controls

Other

MeasureTime frameDescription
Serum Levels of Immune factorBaselineElisa technique was applied to detect the levels of serum Immune factor (IL-2/IL-4/IL-6/IL-17/IL-10/Lipopolysaccharide) in NPM patients and Healthy controls

Countries

China

Contacts

Primary ContactJing Feng
fengjing256@163.com+86-0451-85552102

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026