Clinical Characteristics, Lifestyle and Multi-omics Analysis in Autoimmune Gastritis

Clinical Characteristics, Lifestyle and Integrated Microbiome, Metabolome, Transcriptome, Genome Analysis in Autoimmune Gastritis

This research will be conducted nationwide in patients with autoimmune gastritis, focusing on their clinical characteristics, possible risk factors, and multi-omics analysis. Changes in gastrointestinal microbiota, host and microbial metabolism, gene transcription and biomarkers of autoimmune gastritis will be explored to provide evidence for further precise therapy of the disease.

Study Overview

• Status: Recruiting
• Conditions: Autoimmune Gastritis
• Intervention / Treatment: Biological: Microbiome, metabolome, transcriptome, genome

Detailed Description

Autoimmune gastritis is a chronic progressive disease that may develop into gastric cancer. However, on account of its low morbidity, atypical clinical and endoscopic manifestation, demanding technique for detection of serological markers, the diagnosis and treatment of this disease remains challenging. Therefore, there's inadequate studies focusing on its pathogenesis, metabolism, gene transcription, microbiota etc. In recent years, multi-omics analysis provides clinicians with depth and breadth understandings of diseases. This research, as well, aims at enhancing clinicians' knowledge of autoimmune gastritis to reduce the occurrence of neuroendocrine tumors, gastric cancer, pernicious anemia and other complications.

• Study Type: Observational
• Enrollment (Anticipated): 450

Contacts and Locations

• Study Contact: Name: Jingyuan Fang, MD, Ph.D; Phone Number: +86-02153882450; Email: fangjingyuan@sjtu.edu.cn

Study Locations

• China
  • Shanghai
    • Shanghai, Shanghai, China, 200001
      • Recruiting
      • Shanghai Institute of Digestive Disease
      • Contact: Jingyuan Fang, MD, Ph.D; Phone Number: +86-02153882450; Email: fangjingyuan@sjtu.edu.cn

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

• Sampling Method: Non-Probability Sample

Study Population

Chinese people

Description

Inclusion Criteria:

• Aged 35-75 years.
• Type A atrophic gastritis: Underwent gastroscopy in hospitals mentioned above. Gastroscopy and histopathology showed no significant atrophy of antrum mucosa, but significant atrophy of the body or fundus mucosa, accompanied by positive blood and/or gastric fluid anti-parietal cell antibodies and/or anti-internal factor antibodies. No obvious tumor, deep ulcer, severe bile reflux, severe erosion, or active bleeding. Type B atrophic gastritis: Underwent gastroscopy in hospitals mentioned above. Gastroscopy and histopathological examination showed multifocal atrophy of gastric mucosa, mainly antrum involved. No obvious tumor, ulcer, moderate to severe bile reflux, moderate to severe erosion, multiple polyps (≥2) , or active bleeding. Chronic non-atrophic gastritis: Underwent gastroscopy in hospitals mentioned above. Gastroscopy and histopathology showed chronic inflammation of gastric mucosa with infiltration of lymphocytes and plasma cells, and no intrinsic glandular reduction. No obvious tumor, ulcer, moderate to severe bile reflux, moderate to severe erosion, multiple polyps (≥2) , or active bleeding.
• Underwent colonoscopy within the past 5 years, and no obvious abnormalities such as inflammation, polyps, tumor, or ulcer were observed.
• Have the cognitive level to understand the questionnaire and cooperate voluntarily.

Exclusion Criteria:

• Aged <35 years or>75 years.
• Histopathology indicated dysplasia.
• Long-term use of PPIs or H2-blockers for more than 3 months in the past 1 year. With a history of Helicobacter pylori eradication within the past 2 months.
• Use of antibiotics, nonsteroidal anti-inflammatory drugs, probiotics, steroids, or immunosuppressants for more than 2 weeks within the past 2 months.
• Severe constipation or diarrhea within the past 3 months, or notable changes in bowel habits within the past 3 months.
• History of tumor, organ transplantation, or severe parasitic disease, other diseases of digestive system (such as inflammatory bowel disease, cirrhosis, pancreatitis, etc.), or serious infection.
• History of severe trauma, major operation, extensive burn, cerebral vascular accident, severe organ failure (cardiac, hepatic, renal insufficiency, etc.), shock or sepsis within the past 6 months.
• History of gastrointestinal surgery.
• History of gastrointestinal bleeding, ileus, perforation.
• Chronic metabolic, infectious, or endocrine diseases (such as hypertension, diabetes, hyperlipidemia, hyperuricemia, hyperpurine) that are not well controlled, whether or not treated with medications.
• Vegetarians or had significant changes in eating habits within the past 3 months.

Study Plan

How is the study designed?

Number of groups / cohorts

3

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Type A atrophic gastritis; Gastroscopy and histopathology showed no significant atrophy of antrum mucosa, but significant atrophy of the body or fundus mucosa, accompanied by positive blood and/or gastric fluid anti-parietal cell antibodies and/or anti-internal factor antibodies.	Biological: Microbiome, metabolome, transcriptome, genome; Fecal genome, serum metabolome, leukocyte transcriptome, gastric mucosa genome
Type B atrophic gastritis; Gastroscopy and histopathological examination showed multifocal atrophy of gastric mucosa, mainly antrum involved.	Biological: Microbiome, metabolome, transcriptome, genome; Fecal genome, serum metabolome, leukocyte transcriptome, gastric mucosa genome
Chronic non-atrophic gastritis; Gastroscopy and histopathology showed chronic inflammation of gastric mucosa with infiltration of lymphocytes and plasma cells, and no intrinsic glandular reduction.	Biological: Microbiome, metabolome, transcriptome, genome; Fecal genome, serum metabolome, leukocyte transcriptome, gastric mucosa genome

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Differences in microbiome	Differences in microbiome within or between groups will be explored by metagenomic sequencing and validated by molecular biology experiments	1 year
Differences in metabolome	Differences in microbiome within or between groups will be explored by mass spectrometry and validated by molecular biology experiments	1 year
Differences in transcriptome	Differences in microbiome within or between groups will be explored by transciptome sequencing and validated by molecular biology experiments	1 year
Differences in genome	Differences in microbiome within or between groups will be explored by 16s RNA sequencing and validated by molecular biology experiments	1 year

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Differences in clinical outcomes	Differences in clinical outcomes of Group 1, whether subjects have complications, such as folic acid or vitamin B12 deficiency (folic acid<3.1ug/L, vitamin B12<180pg/ml), anemia ( male Hb<130g/L, female Hb<115g/L), hyperplastic polyp, pseudopolyp, pyloric adenoma, type 1 neuroendocrine tumor or gastric cancer (pathologically confirmed), all these complications will be reported separately	1 year
Differences in lifestyle	Differences in lifestyle within or between groups acquired by food frequency questionnaire and analyzed by statistical approaches	1 year

Collaborators and Investigators

• Sponsor: Shanghai Jiao Tong University School of Medicine
• Collaborators: The First Affiliated Hospital of Nanchang University; The Affiliated Hospital of Qingdao University; Shanghai Tong Ren Hospital; Tianjin Medical University General Hospital; Southern Medical University, China; Seventh Medical Center of PLA Army General Hospital
• Investigators: Principal Investigator: Jingyuan Fang, MD, Ph.D, Shanghai Institute of Digestive Disease

Study record dates

Study Major Dates

• Study Start (Actual): June 19, 2022
• Primary Completion (Anticipated): July 1, 2023
• Study Completion (Anticipated): July 1, 2024

Study Registration Dates

• First Submitted: March 23, 2023
• First Submitted That Met QC Criteria: April 17, 2023
• First Posted (Actual): April 19, 2023

Study Record Updates

• Last Update Posted (Actual): April 19, 2023
• Last Update Submitted That Met QC Criteria: April 17, 2023
• Last Verified: April 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Gastrointestinal Diseases; Stomach Diseases; Gastroenteritis; Gastritis
• Other Study ID Numbers: KY2022-134-B

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