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

NCT05820607 | Unknown

• 1 other identifier: KY2022-134-B
• Study Type: observational
• Target: 450
• Locations: 1 country
• Sites: 1

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.

Conditions

Autoimmune Gastritis

Outcome Measures

Primary Outcomes (4)

• 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 Outcomes (2)

• Differences in clinical outcomes

  1 year

• Differences in lifestyle

  1 year

Study Arms (3)

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

Type B atrophic gastritis

Gastroscopy and histopathological examination showed multifocal atrophy of gastric mucosa, mainly antrum involved.

Biological: Microbiome, metabolome, transcriptome, 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

Interventions

Microbiome, metabolome, transcriptome, genome BIOLOGICAL

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

Chronic non-atrophic gastritis; Type A atrophic gastritis; Type B atrophic gastritis

Eligibility Criteria

• Age: 35 Years - 75 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Chinese people

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Shanghai Jiao Tong University School of Medicine: lead
• Shanghai Tong Ren Hospital: collaborator
• Seventh Medical Center of PLA Army General Hospital: collaborator
• Tianjin Medical University General Hospital: collaborator
• The Affiliated Hospital of Qingdao University: collaborator
• Southern Medical University, China: collaborator
• The First Affiliated Hospital of Nanchang University: collaborator

Study Sites (1)

Shanghai Institute of Digestive Disease

Shanghai, Shanghai Municipality, 200001, China

RECRUITING

Biospecimen

Retention: SAMPLES WITH DNA

Blood specimen, gastric mucosa biopsy tissue specimen and feces specimen

MeSH Terms

Interventions

Microbiota; Metabolome; Transcriptome; Genome

Intervention Hierarchy (Ancestors)

Microbiological Phenomena; Biota; Biodiversity; Ecosystem; Environment; Ecological and Environmental Phenomena; Biological Phenomena; Environment and Public Health; Metabolism; Transcription, Genetic; Biochemical Phenomena; Chemical Phenomena; Gene Expression; Genetic Phenomena; Genetic Structures

Study Officials

• Jingyuan Fang, MD, Ph.D

  Shanghai Institute of Digestive Disease

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Jingyuan Fang, MD, Ph.D

CONTACT

+86-02153882450; fangjingyuan@sjtu.edu.cn

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director of Department of Gastroenterology of Renji Hospital

Study Record Dates

• First Submitted: March 23, 2023
• First Posted: April 19, 2023
• Study Start: June 19, 2022
• Primary Completion: July 1, 2023
• Study Completion: July 1, 2024
• Last Updated: April 19, 2023

Record last verified: 2023-04

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)