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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05051215
Other study ID # Jing Feng 2021-08-15
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date August 15, 2021
Est. completion date August 15, 2024

Study information

Verified date September 2021
Source First Affiliated Hospital of Harbin Medical University
Contact Jing Feng
Phone +86-0451-85552102
Email fengjing256@163.com
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Recruiting
Enrollment 100
Est. completion date August 15, 2024
Est. primary completion date August 15, 2023
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Female
Age group 18 Years to 65 Years
Eligibility 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

Study Design


Related Conditions & MeSH terms


Locations

Country Name City State
China First affiliated hospital of Harbin medical university Harbin Heilongjiang

Sponsors (1)

Lead Sponsor Collaborator
First Affiliated Hospital of Harbin Medical University

Country where clinical trial is conducted

China, 

Outcome

Type Measure Description Time frame Safety issue
Other 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
Primary 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
Secondary 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
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