Gut Microbiota and Nonpuerperal Mastitis

NCT ID: NCT05051215

Last Updated: 2021-09-21

Basic Information

• Recruitment Status: UNKNOWN
• Total Enrollment: 100 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2021-08-15
• Study Completion Date: 2024-08-15

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.

Conditions

Microbiota

Study Design

• Observational Model Type: CASE_CONTROL
• Study Time Perspective: CROSS_SECTIONAL

Study Groups

Control group

40 healthy volunteers were included in the healthy control group

Intervention Type: OTHER

NPM group

60 patients of NPM (30 PCM and 30 GM)were included

Intervention Type: OTHER

Interventions

Intervention Type: OTHER

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

First Affiliated Hospital of Harbin Medical University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Jing Feng

Role: STUDY_DIRECTOR

First Affiliated Hospital of Harbin Medical University

Locations

First affiliated hospital of Harbin medical university

Harbin, Heilongjiang, China

Site Status: RECRUITING

Countries

China

Central Contacts

Jing Feng

Role: CONTACT

fengjing256@163.com

+86-0451-85552102

Facility Contacts

Jing Feng

Role: primary

fengjing256@163.com

+86-0451-85552102

Other Identifiers

Jing Feng 2021-08-15

Identifier Type: -

Identifier Source: org_study_id