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

NCT ID: NCT05820607

Last Updated: 2023-04-19

Basic Information

• Recruitment Status: UNKNOWN
• Total Enrollment: 450 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2022-06-19
• Study Completion Date: 2024-07-31

Brief Summary

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.

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.

Conditions

Autoimmune Gastritis

Study Design

• Observational Model Type: CASE_CONTROL
• Study Time Perspective: RETROSPECTIVE

Study Groups

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.

Microbiome, metabolome, transcriptome, genome

Intervention Type: BIOLOGICAL

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.

Microbiome, metabolome, transcriptome, genome

Intervention Type: BIOLOGICAL

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.

Microbiome, metabolome, transcriptome, genome

Intervention Type: BIOLOGICAL

Fecal genome, serum metabolome, leukocyte transcriptome, gastric mucosa genome

Interventions

Microbiome, metabolome, transcriptome, genome

Fecal genome, serum metabolome, leukocyte transcriptome, gastric mucosa genome

Intervention Type: BIOLOGICAL

Eligibility Criteria

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.

• Minimum Eligible Age: 35 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Shanghai Tong Ren Hospital

OTHER

Sponsor Role: collaborator

Seventh Medical Center of PLA Army General Hospital

OTHER

Sponsor Role: collaborator

Tianjin Medical University General Hospital

OTHER

Sponsor Role: collaborator

The Affiliated Hospital of Qingdao University

OTHER

Sponsor Role: collaborator

Southern Medical University, China

OTHER

Sponsor Role: collaborator

The First Affiliated Hospital of Nanchang University

OTHER

Sponsor Role: collaborator

Shanghai Jiao Tong University School of Medicine

OTHER

Sponsor Role: lead

Responsible Party

Jing-yuan Fang, MD, Ph. D

Director of Department of Gastroenterology of Renji Hospital

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Jingyuan Fang, MD, Ph.D

Role: PRINCIPAL_INVESTIGATOR

Shanghai Institute of Digestive Disease

Locations

Shanghai Institute of Digestive Disease

Shanghai, Shanghai Municipality, China

Site Status: RECRUITING

Countries

China

Central Contacts

Jingyuan Fang, MD, Ph.D

Role: CONTACT

fangjingyuan@sjtu.edu.cn

+86-02153882450

Facility Contacts

Jingyuan Fang, MD, Ph.D

Role: primary

fangjingyuan@sjtu.edu.cn

+86-02153882450

Other Identifiers

KY2022-134-B

Identifier Type: -

Identifier Source: org_study_id