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Clinical Characteristics, Lifestyle and Multi-omics Analysis in Autoimmune Gastritis | Clinical Trials | Clareo Health

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

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

NCT05820607•Shanghai Jiao Tong University School of Medicine

View on ClinicalTrials.gov

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.

Eligibility

Age

35 - 75 years

Sex

ALL

Healthy Volunteers

Yes

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.
+1 more criteria

Locations (1)

Shanghai Institute of Digestive Disease

Shanghai, Shanghai Municipality, China

Key Dates

Start Date

June 19, 2022

Primary Completion Date

July 1, 2023

Completion Date

July 1, 2024

Last Updated

April 19, 2023

Enrollment

450

ESTIMATED participants

Conditions

Autoimmune Gastritis

Interventions

Microbiome, metabolome, transcriptome, genome

BIOLOGICAL

Contacts

Jingyuan Fang, MD, Ph.D

CONTACT

+86-02153882450 fangjingyuan@sjtu.edu.cn

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: April 19, 2023Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

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