Gut Microbiota and Nonpuerperal Mastitis

NCT05051215 | Unknown

• 1 other identifier: Jing Feng 2021-08-15
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 1

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.

Conditions

Microbiota

Keywords

Gut Microbiota; Nonpuerperal mastitis; Plasma cell mastitis; Granulomatous mastitis; Metabonomics

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Metabolic profiling of Nonpuerperal Mastitis patients and Healthy controls

  Baseline

Other Outcomes (1)

• Serum Levels of Immune factor

  Baseline

Study Arms (2)

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

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• 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

You may qualify if:

• Aged 18 to 65 years
• Patients of NPM

You may not qualify if:

• 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

Sponsors & Collaborators

• First Affiliated Hospital of Harbin Medical University: lead

Study Sites (1)

First affiliated hospital of Harbin medical university

Harbin, Heilongjiang, 150001, China

RECRUITING

Biospecimen

Retention: SAMPLES WITH DNA

microbiota DNA are extracted from human feces

MeSH Terms

Conditions

Granulomatous Mastitis

Condition Hierarchy (Ancestors)

Mastitis; Puerperal Disorders; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Study Officials

• Jing Feng

  First Affiliated Hospital of Harbin Medical University

  STUDY DIRECTOR

Central Study Contacts

Jing Feng

CONTACT

+86-0451-85552102; fengjing256@163.com

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 6, 2021
• First Posted: September 21, 2021
• Study Start: August 15, 2021
• Primary Completion: August 15, 2023
• Study Completion: August 15, 2024
• Last Updated: September 21, 2021

Record last verified: 2021-09

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)