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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

Status
UNKNOWN
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT05820607
Enrollment
450
Registered
2023-04-19
Start date
2022-06-19
Completion date
2024-07-31
Last updated
2023-04-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Autoimmune Gastritis

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.

Interventions

BIOLOGICALMicrobiome, metabolome, transcriptome, genome

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

Sponsors

Shanghai Tong Ren Hospital
CollaboratorOTHER
Seventh Medical Center of PLA Army General Hospital
CollaboratorOTHER
Tianjin Medical University General Hospital
CollaboratorOTHER
The Affiliated Hospital of Qingdao University
CollaboratorOTHER
Southern Medical University, China
CollaboratorOTHER
The First Affiliated Hospital of Nanchang University
CollaboratorOTHER
Shanghai Jiao Tong University School of Medicine
Lead SponsorOTHER

Study design

Observational model
CASE_CONTROL
Time perspective
RETROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
35 Years to 75 Years
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. * Vegetarians or had significant changes in eating habits within the past 3 months.

Design outcomes

Primary

MeasureTime frameDescription
Differences in microbiome1 yearDifferences in microbiome within or between groups will be explored by metagenomic sequencing and validated by molecular biology experiments
Differences in metabolome1 yearDifferences in microbiome within or between groups will be explored by mass spectrometry and validated by molecular biology experiments
Differences in transcriptome1 yearDifferences in microbiome within or between groups will be explored by transciptome sequencing and validated by molecular biology experiments
Differences in genome1 yearDifferences in microbiome within or between groups will be explored by 16s RNA sequencing and validated by molecular biology experiments

Secondary

MeasureTime frameDescription
Differences in clinical outcomes1 yearDifferences 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
Differences in lifestyle1 yearDifferences in lifestyle within or between groups acquired by food frequency questionnaire and analyzed by statistical approaches

Countries

China

Contacts

Primary ContactJingyuan Fang, MD, Ph.D
fangjingyuan@sjtu.edu.cn+86-02153882450

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026