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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Control group | 40 healthy volunteers were included in the healthy control group | ||
| NPM group | 60 patients of NPM (30 PCM and 30 GM)were included |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Other |
|
| Measure | Description | Time Frame |
|---|---|---|
| Microbial profiling of Nonpuerperal Mastitis patients and Healthy controls | 16S 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. | Baseline |
| Measure | Description | Time Frame |
|---|---|---|
| Metabolic profiling of Nonpuerperal Mastitis patients and Healthy controls | Fecal 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 | Baseline |
| Measure | Description | Time Frame |
|---|---|---|
| Serum Levels of Immune factor | Elisa 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 | Baseline |
Inclusion Criteria:
Exclusion Criteria:
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Study Population are aged from 18 to 65 years#which divided into 2 groups: NPM group and Control group
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Jing Feng | Contact | +86-0451-85552102 | fengjing256@163.com |
| Name | Affiliation | Role |
|---|---|---|
| Jing Feng | First Affiliated Hospital of Harbin Medical University | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| First affiliated hospital of Harbin medical university | Recruiting | Harbin | Heilongjiang | 150001 | China |
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| ID | Term |
|---|---|
| D058890 | Granulomatous Mastitis |
| ID | Term |
|---|---|
| D008413 | Mastitis |
| D011644 | Puerperal Disorders |
| D011248 | Pregnancy Complications |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
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microbiota DNA are extracted from human feces
| D000091642 | Urogenital Diseases |
| D001941 | Breast Diseases |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |