Clinical trial NCT05051215: Gut Microbiota and Nonpuerperal Mastitis
Official title: Alterations in the Gut Microbiota and Metabolite Profiles of Nonpuerperal Mastitis Patients
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Microbiota
Keywords: Gut Microbiota
Nonpuerperal mastitis
Plasma cell mastitis
Granulomatous mastitis
Metabonomics
Lead sponsor: First Affiliated Hospital of Harbin Medical University
Sponsor class: OTHER
First posted: 2021-09-21
Enrollment: 100
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: CROSS_SECTIONAL
Sampling method: PROBABILITY_SAMPLE
Study population: Study Population are aged from 18 to 65 years#which divided into 2 groups: NPM group and Control group

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.

Eligibility criteria: 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

Primary outcomes:
measure: Microbial profiling of Nonpuerperal Mastitis patients and Healthy controls
timeFrame: Baseline
Secondary outcomes:
measure: Metabolic profiling of Nonpuerperal Mastitis patients and Healthy controls
timeFrame: Baseline
Other outcomes:
measure: Serum Levels of Immune factor
timeFrame: Baseline
Locations:
city: Harbin
country: China
facility: First affiliated hospital of Harbin medical university
state: Heilongjiang
Study officials:
affiliation: First Affiliated Hospital of Harbin Medical University
name: Jing Feng
role: STUDY_DIRECTOR
References: