Gut Microbiota and Nonpuerperal Mastitis

Microbiota Clinical Trial

Official title:

Alterations in the Gut Microbiota and Metabolite Profiles of Nonpuerperal Mastitis Patients

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05051215
• Other study ID #: Jing Feng 2021-08-15
• Status: Recruiting
• 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
• 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

Related Conditions & MeSH terms

• Mastitis
• Microbiota

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