Gut Microbiota and Nonpuerperal Mastitis
Study Details
Study Description
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.
Condition or Disease | Intervention/Treatment | Phase |
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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.
Study Design
Arms and Interventions
Arm | Intervention/Treatment |
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Control group 40 healthy volunteers were included in the healthy control group |
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NPM group 60 patients of NPM (30 PCM and 30 GM)were included |
Outcome Measures
Primary Outcome Measures
- Microbial profiling of Nonpuerperal Mastitis patients and Healthy controls [Baseline]
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.
Secondary Outcome Measures
- Metabolic profiling of Nonpuerperal Mastitis patients and Healthy controls [Baseline]
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
Other Outcome Measures
- Serum Levels of Immune factor [Baseline]
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
Eligibility Criteria
Criteria
Inclusion Criteria:
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Aged 18 to 65 years
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Patients of NPM
Exclusion Criteria:
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Pregnancy
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Lactation
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Cigarette smoking
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Alcohol addiction
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Hypertension
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Diabetes mellitus
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Lipid dysregulation
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BMI > 27 <18.5
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Recent (< 1 months prior) use of antibiotics, probiotics, prebiotics, synbiotic, hormonal medication, laxatives, proton pump inhibitors, insulin sensitizers or Chinese herbal medicine
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History of disease with an autoimmune component, such as multiple sclerosis(MS), rheumatoid arthritis, irritable bowel disease(IBS), or irritable bowel syndrome(IBD)
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History of malignancy or any gastrointestinal tract surgery
Contacts and Locations
Locations
Site | City | State | Country | Postal Code | |
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1 | First affiliated hospital of Harbin medical university | Harbin | Heilongjiang | China | 150001 |
Sponsors and Collaborators
- First Affiliated Hospital of Harbin Medical University
Investigators
- Study Director: Jing Feng, First Affiliated Hospital of Harbin Medical University
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- Jing Feng 2021-08-15