Gut Microbiota and Nonpuerperal Mastitis

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

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.

Study Overview

• Status: Recruiting
• Conditions: Microbiota
• Intervention / Treatment: Other

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 Type: Observational
• Enrollment (Anticipated): 100

Contacts and Locations

• Study Contact: Name: Jing Feng; Phone Number: +86-0451-85552102; Email: fengjing256@163.com

Study Locations

• China
  • Heilongjiang
    • Harbin, Heilongjiang, China, 150001
      • Recruiting
      • First Affiliated Hospital of Harbin Medical University
      • Contact: Jing Feng; Phone Number: +86-0451-85552102; Email: fengjing256@163.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: Female

• 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

Description

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 Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort
Control group; 40 healthy volunteers were included in the healthy control group
NPM group; 60 patients of NPM (30 PCM and 30 GM)were included

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: First Affiliated Hospital of Harbin Medical University
• Investigators: Study Director: Jing Feng, First Affiliated Hospital of Harbin Medical University

Study record dates

Study Major Dates

• Study Start (Actual): August 15, 2021
• Primary Completion (Anticipated): August 15, 2023
• Study Completion (Anticipated): August 15, 2024

Study Registration Dates

• First Submitted: September 6, 2021
• First Submitted That Met QC Criteria: September 9, 2021
• First Posted (Actual): September 21, 2021

Study Record Updates

• Last Update Posted (Actual): September 21, 2021
• Last Update Submitted That Met QC Criteria: September 9, 2021
• Last Verified: September 1, 2021

More Information

Terms related to this study

• Keywords: Gut Microbiota; Metabonomics; Nonpuerperal mastitis; Plasma cell mastitis; Granulomatous mastitis
• Additional Relevant MeSH Terms: Skin Diseases; Breast Diseases; Pregnancy Complications; Puerperal Disorders; Mastitis
• Other Study ID Numbers: Jing Feng 2021-08-15

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No