Actively Recruiting
Assessing the Prevalence and Epidemiological Characteristics of Small Intestinal Bacterial Overgrowth (SIBO) in Patients With Autoimmune Gastritis(AIG) Through Hydrogen and Methane Breath Testing(HMBT).
Led by RenJi Hospital · Updated on 2025-04-27
220
Participants Needed
1
Research Sites
77 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Evaluate the prevalence of small intestinal bacterial overgrowth in patients with autoimmune gastritis (AIG) through hydrogen and methane breath testing, and determine whether there are differences in the positive rates of hydrogen and methane breath testing among the AIG group, the acid suppression group, and the control group.
CONDITIONS
Official Title
Assessing the Prevalence and Epidemiological Characteristics of Small Intestinal Bacterial Overgrowth (SIBO) in Patients With Autoimmune Gastritis(AIG) Through Hydrogen and Methane Breath Testing(HMBT).
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 18 to 65 years, any gender
- Diagnosed with autoimmune gastritis confirmed by gastroscopy or histology and serological tests (AIG group)
- No inflammatory bowel disease, malignant tumors, or bowel obstruction based on colonoscopy or intestinal CT
- At least 2 weeks without proton pump inhibitors or potassium-competitive acid blockers (AIG and control groups)
- Able to complete hydrogen and methane breath tests and questionnaires independently or with assistance
- Able to provide informed consent
- Need long-term acid inhibitor treatment (PPI more than 8 weeks or P-CAB more than 4 weeks) for gastroesophageal reflux or other reasons (acid suppression group)
- Gastroscopy within 1 year showing no or mild gastric mucosal atrophy (acid suppression and control groups)
You will not qualify if you...
- Active gastrointestinal ulcers found by endoscopy
- History of malignant tumors in the digestive system or inflammatory bowel disease
- Past pseudo or mechanical bowel obstruction
- Previous gastrointestinal resection surgery
- Appendectomy or cholecystectomy within 1 year
- History of gastrointestinal perforation, bleeding, cholangitis, or pancreatitis within 1 year
- Current gastrointestinal infections such as Helicobacter pylori or acute infectious enteritis
- History of type I diabetes or primary hypothyroidism (normal thyroid function allowed)
- Diagnosed lactose malabsorption, lactose intolerance, or pancreatic exocrine dysfunction
- Antibiotic use within 4 weeks
- Endoscopic examination within 2 weeks
- Use of gastrointestinal motility drugs, probiotics, or laxatives within 1 week
- Consumption of fermentable foods (e.g., yogurt, kimchi, soy sauce, oats, beer) the day before testing
- Not fasting for 8 hours before testing
- Smoking or vigorous exercise 2 hours before or during testing
- Respiratory diseases or inability to fast/drink leading to inability to complete breath tests
- Pregnancy, breastfeeding, poor compliance, or other conditions requiring exclusion
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Shanghai Institute of Digestive Disease
Shanghai, Shanghai Municipality, China, 200001
Actively Recruiting
Research Team
Y
Ying-xuan Chen Ying-xuan Chen, MD, Ph.D
CONTACT
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
3
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