Gut Microbiota and Nonpuerperal Mastitis

NCT05051215 — Unknown, 100 participants, First Affiliated Hospital of Harbin Medical University

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

Registry	NCT05051215
Status	Unknown
Study type	Observational
Enrollment	100 (Estimated)
Sponsor	First Affiliated Hospital of Harbin Medical University (Other)
Conditions	Microbiota
Interventions	(Other)
Dates	start 2021-08-15, primary completion 2023-08-15 (estimated), completion 2024-08-15 (estimated), first posted 2021-09-21, last updated 2021-09-21
Locations	1 site in China

-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.

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+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.

+Arms and interventions

Arm	Type	Interventions	Description
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

(Other)

+Outcome measures

Primary outcomes

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 outcomes

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 outcomes

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

Sex: Female, ages: 18 Years to 65 Years, accepts healthy volunteers

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

+Locations (1)

Facility	City	Country	Status
First affiliated hospital of Harbin medical university	Harbin, Heilongjiang	China	Recruiting

+Investigators

Jing Feng, Study director, First Affiliated Hospital of Harbin Medical University