Clinical trial

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

Name
KY2022-134-B
Description
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.
Trial arms
Trial start
2022-06-19
Estimated PCD
2023-07-01
Trial end
2024-07-01
Status
Recruiting
Treatment
Microbiome, metabolome, transcriptome, genome
Fecal genome, serum metabolome, leukocyte transcriptome, gastric mucosa genome
Arms:
Chronic non-atrophic gastritis, Type A atrophic gastritis, Type B atrophic gastritis
Size
450
Primary endpoint
Differences in microbiome
1 year
Differences in metabolome
1 year
Differences in transcriptome
1 year
Differences in genome
1 year
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.
Protocol
{'studyType': 'OBSERVATIONAL', 'patientRegistry': False, 'designInfo': {'observationalModel': 'CASE_CONTROL', 'timePerspective': 'RETROSPECTIVE'}, 'bioSpec': {'retention': 'SAMPLES_WITH_DNA', 'description': 'Blood specimen, gastric mucosa biopsy tissue specimen and feces specimen'}, 'enrollmentInfo': {'count': 450, 'type': 'ESTIMATED'}}
Updated at
2023-04-19

1 organization

1 product

1 indication

Product
Microbiome