Autoimmune GastritisNCT05820607
Clinical Characteristics, Lifestyle and Multi-omics Analysis in Autoimmune Gastritis
An observational study of Autoimmune Gastritis, run by Shanghai Jiao Tong University School of Medicine at 1 site in China.
Trial 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… Read more about this study
- Who is it for?
- Ages 35 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Autoimmune Gastritis
- What is being tested?
- Microbiome, metabolome, transcriptome, genome
- How many people
- 450 participants
- Where
- 1 siteChina
- Study dates
- 19 Jun 2022to Jul 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 35 to 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Chinese people
Who may be able to join
- 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.
Who cannot join
- 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.
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- 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.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Shanghai Institute of Digestive Disease
Shanghai, Shanghai Municipality, 200001
Jingyuan Fang, MD, Ph.D, +86-02153882450, fangjingyuan@sjtu.edu.cn
About this study
Official title: Clinical Characteristics, Lifestyle and Integrated Microbiome, Metabolome, Transcriptome, Genome Analysis in Autoimmune Gastritis
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.
Read the 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
- Being tested
- Microbiome, metabolome, transcriptome, genome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Microbiome, metabolome, transcriptome, genomeBiological
Fecal genome, serum metabolome, leukocyte transcriptome, gastric mucosa genome
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Biological: Microbiome, metabolome, transcriptome, genome | |
| Type B atrophic gastritis | Gastroscopy and histopathological examination showed multifocal atrophy of gastric mucosa, mainly antrum involved. Receives: 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. Receives: Biological: Microbiome, metabolome, transcriptome, genome |
What is being measured
The primary outcome is the main question the study is designed to answer.
Differences in microbiome
Differences in microbiome within or between groups will be explored by metagenomic sequencing and validated by molecular biology experiments
Measured: 1 year
Differences in metabolome
Differences in microbiome within or between groups will be explored by mass spectrometry and validated by molecular biology experiments
Measured: 1 year
Differences in transcriptome
Differences in microbiome within or between groups will be explored by transciptome sequencing and validated by molecular biology experiments
Measured: 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
Measured: 1 year
Secondary outcomes (2)
Differences in clinical outcomes
Differences 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
Measured: 1 year
Differences in lifestyle
Differences in lifestyle within or between groups acquired by food frequency questionnaire and analyzed by statistical approaches
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Apr 2023
- Study start19 Jun 2022
- Primary completionJul 2023 (estimated)
- Study completionJul 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Autoimmune GastritisStudies of the same condition, open and under way.
- More trials run by Shanghai Jiao Tong University School of MedicineThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Retrospective
- Enrolment
- 450 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shanghai Jiao Tong University School of Medicine
- Sponsor type
- University, hospital or other
- Collaborators
- Shanghai Tong Ren Hospital, Seventh Medical Center of PLA Army General Hospital, Tianjin Medical University General Hospital, The Affiliated Hospital of Qingdao University, Southern Medical University, China, The First Affiliated Hospital of Nanchang University
- Responsible party
- Principal investigator, Jing-yuan Fang, MD, Ph. D, Shanghai Jiao Tong University School of Medicine
- Investigators
- Jingyuan Fang, MD, Ph.D, Principal investigator, Shanghai Institute of Digestive Disease
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05820607
- Sponsor's protocol ID
- KY2022-134-B
- Status last verified
- Apr 2023
- First submitted
- 23 Mar 2023
- Last updated
- 19 Apr 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Characteristics, Lifestyle and Integrated Microbiome, Metabolome, Transcriptome, Genome Analysis in Autoimmune Gastritis
- ClinicalTrials.gov ID
- NCT05820607
- Acronym / sponsor ID
- KY2022-134-B
- Conditions
- Autoimmune Gastritis
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 450 participants (estimated)
- Lead sponsor
- Shanghai Jiao Tong University School of MedicineUniversity, hospital or other
- Collaborators
- Shanghai Tong Ren Hospital, Seventh Medical Center of PLA Army General Hospital, Tianjin Medical University General Hospital, The Affiliated Hospital of Qingdao University, Southern Medical University, China, The First Affiliated Hospital of Nanchang University
- Study start
- 19 Jun 2022 (actual)
- Primary completion
- Jul 2023 (estimated)
- Study completion
- Jul 2024 (estimated)
- First posted
- 19 Apr 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case-control
- Time perspective
- Retrospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Type A atrophic gastritis | – | Biological: Microbiome, metabolome, transcriptome, genomeGastroscopy 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. |
| Type B atrophic gastritis | – | Biological: Microbiome, metabolome, transcriptome, genomeGastroscopy and histopathological examination showed multifocal atrophy of gastric mucosa, mainly antrum involved. |
| Chronic non-atrophic gastritis | – | Biological: Microbiome, metabolome, transcriptome, genomeGastroscopy and histopathology showed chronic inflammation of gastric mucosa with infiltration of lymphocytes and plasma cells, and no intrinsic glandular reduction. |
Who may qualify
- Ages
- 35 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Chinese people
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (11 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Microbiome, metabolome, transcriptome, genomeFecal genome, serum metabolome, leukocyte transcriptome, gastric mucosa genome | Biological | Chronic non-atrophic gastritis, Type A atrophic gastritis, Type B atrophic gastritis |
Primary outcome
Differences in microbiome
Time frame: 1 year
Differences in microbiome within or between groups will be explored by metagenomic sequencing and validated by molecular biology experiments
Differences in metabolome
Time frame: 1 year
Differences in microbiome within or between groups will be explored by mass spectrometry and validated by molecular biology experiments
Differences in transcriptome
Time frame: 1 year
Differences in microbiome within or between groups will be explored by transciptome sequencing and validated by molecular biology experiments
Differences in genome
Time frame: 1 year
Differences in microbiome within or between groups will be explored by 16s RNA sequencing and validated by molecular biology experiments
2 secondary outcomes
Differences in clinical outcomes
Time frame: 1 year
Differences in lifestyle
Time frame: 1 year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Apr 2023.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jingyuan Fang, MD, Ph.D principal investigator
Shanghai Institute of Digestive Disease
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Autoimmune Gastritis, run by Shanghai Jiao Tong University School of Medicine at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 19 Apr 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Jingyuan Fang, MD, Ph.D (+86-02153882450, fangjingyuan@sjtu.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Differences in microbiome (time frame: 1 year). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Apr 2023.