Gut Microbiota and Nonpuerperal Mastitis

Sponsor
First Affiliated Hospital of Harbin Medical University (Other)
Overall Status
Recruiting
CT.gov ID
NCT05051215
Collaborator
(none)
100
1
36
2.8

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase

    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 Design

    Study Type:
    Observational
    Anticipated Enrollment :
    100 participants
    Observational Model:
    Case-Control
    Time Perspective:
    Cross-Sectional
    Official Title:
    Alterations in the Gut Microbiota and Metabolite Profiles of Nonpuerperal Mastitis Patients
    Actual Study Start Date :
    Aug 15, 2021
    Anticipated Primary Completion Date :
    Aug 15, 2023
    Anticipated Study Completion Date :
    Aug 15, 2024

    Arms and Interventions

    Arm Intervention/Treatment
    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

    Outcome Measures

    Primary Outcome Measures

    1. Microbial profiling of Nonpuerperal Mastitis patients and Healthy controls [Baseline]

      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.

    Secondary Outcome Measures

    1. Metabolic profiling of Nonpuerperal Mastitis patients and Healthy controls [Baseline]

      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

    Other Outcome Measures

    1. Serum Levels of Immune factor [Baseline]

      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

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 65 Years
    Sexes Eligible for Study:
    Female
    Accepts Healthy Volunteers:
    Yes
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 First affiliated hospital of Harbin medical university Harbin Heilongjiang China 150001

    Sponsors and Collaborators

    • First Affiliated Hospital of Harbin Medical University

    Investigators

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

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    First Affiliated Hospital of Harbin Medical University
    ClinicalTrials.gov Identifier:
    NCT05051215
    Other Study ID Numbers:
    • Jing Feng 2021-08-15
    First Posted:
    Sep 21, 2021
    Last Update Posted:
    Sep 21, 2021
    Last Verified:
    Sep 1, 2021
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by First Affiliated Hospital of Harbin Medical University
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of Sep 21, 2021