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). (HMBT、SIBO、AIG)

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).

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.

Study Overview

• Status: Recruiting
• Conditions: Autoimmune Gastritis
• Intervention / Treatment: Diagnostic test: hydrogen and methane breath testing

• Study Type: Observational
• Enrollment (Estimated): 220

Contacts and Locations

• Study Contact: Name: Ying-xuan Chen Ying-xuan Chen, MD, Ph.D; Phone Number: +86-02158729363; Email: Yingxuanchen71@126.com

Study Locations

• China
  • Shanghai
    • Shanghai, Shanghai, China, 200001
      • Recruiting
      • Shanghai Institute of Digestive Disease
      • Contact: Ying-xuan Chen Ying-xuan Chen, MD, Ph.D; Phone Number: +862158729363; Email: Yingxuanchen71@126.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: N/A

• Sampling Method: Non-Probability Sample

Study Population

Chinese people

Description

Inclusion Criteria:

• Inclusion criteria for the AIG group:

  1. Age range: 18-65 years old, without gender limitation;
  2. Patients diagnosed with AIG: Previous gastroscopy (or) histological findings consistent with AIG, and serological tests support the diagnosis of AIG;
  3. Previous colonoscopy or intestinal CT have ruled out inflammatory bowel disease, malignant tumors, history of pseudo and mechanical bowel obstruction, and there is currently no evidence to support these diseases;
  4. At least 2 weeks without taking PPI/P-CAB;
  5. Possessing the ability to independently or with the assistance of medical staff, complete hydrogen and methane breath tests and related questionnaire scoring;
  6. Capable of completing the signing of informed consent forms as required.

Inclusion criteria for the acid suppression group:

1. Age: 18-65 years old, without gender limitation;
2. Patients who are non-AIG and need long-term acid inhibitor (PPI more than 8 weeks or P-CAB more than 4 weeks) due to gastroesophageal reflux and other reasons;
3. Patients with a 1-year history of gastroscopy, with no degree of microscopic atrophy, or with mild gastric mucosal atrophy (C-I and C-II according to the Kimura-Takemoto classification);
4. Previous colonoscopy or intestinal CT have ruled out inflammatory bowel disease, malignant tumors, history of pseudo and mechanical bowel obstruction, and there is currently no evidence to support these diseases;
5. Possessing the ability to independently or with the assistance of medical staff, complete hydrogen and methane breath tests and related questionnaire scoring;
6. Capable of completing the signing of informed consent forms as required.

Inclusion criteria for the control group:

1. Age: 18-65 years old, without gender limitation;
2. Patients with a 1-year history of gastroscopy, with no degree of microscopic atrophy, or with mild gastric mucosal atrophy (C-I and C-II according to the Kimura-Takemoto classification);

4) Previous colonoscopy or intestinal CT have ruled out inflammatory bowel disease, malignant tumors, history of pseudo and mechanical bowel obstruction, and there is currently no evidence to support these diseases; 4) At least 2 weeks without taking PPI/P-CAB; 5) Possessing the ability to independently or with the assistance of medical staff, complete hydrogen and methane breath tests and related questionnaire scoring; 6) Capable of completing the signing of informed consent forms as required.

Exclusion Criteria:

• 1)Gastrointestinal endoscopy suggests patients with active gastrointestinal ulcers; 2)History of malignant tumors of the digestive system (not limited to the digestive tract), inflammatory bowel disease, and pseudo or mechanical bowel obstruction in the past; 3)Previous gastrointestinal resection surgery;appendectomy and cholecystectomy within 1 year; 4)History of gastrointestinal perforation, gastrointestinal bleeding, cholangitis, and acute or chronic pancreatitis within one year; 5)Evidence suggests current gastrointestinal infections (Helicobacter pylori, acute infectious enteritis); 6)History of type I diabetes and primary hypothyroidism (the patients with normal thyroid function can be included); 7)Diagnosed lactose malabsorption, lactose intolerance, and pancreatic exocrine dysfunction; 8)History of antibiotic use within four weeks; 9)History of endoscopic examination within two weeks; 10)History of taking gastrointestinal motility promoting drugs, probiotics, and laxatives within one week; 11)On the day before the test, consume fermentable foods such as yogurt, kimchi, soy sauce, oats, beer, etc; 12)Eight hours prior to testing, without fasting; 13)Smoking and vigorous exercise two hours before and during the testing period; 14)Difficulty in exhaling due to respiratory system diseases, or inability to fast or drink for extended periods of time, resulting in inability to complete hydrogen and methane breath tests; 15)Pregnant, lactating women, or those with poor overall compliance, or other situations that researchers consider necessary to exclude.

Study Plan

How is the study designed?

Number of groups / cohorts

3

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
the AIG group; Patients diagnosed with AIG: Previous gastroscopy (or) histological findings consistent with AIG, and serological tests support the diagnosis of AIG	Diagnostic test: hydrogen and methane breath testing; The hydrogen and methane breath testingt(HMBT) is a non-invasive method based on gas analysis of gut microbiota metabolomics.Normal human metabolic processes do not produce methane and hydrogen, and all methane and hydrogen in exhaled breath come from metabolites produced during the fermentation of substrates by gut microbiota. About 14-21% of the gas can diffuse through the intestinal mucosa to the bloodstream, circulate through the bloodstream to the alveoli, and be exhaled through gas exchange.Based on substrate properties, separate and measure methane and hydrogen concentrations from exhaled breath for non-invasive, convenient, and accurate diagnosis of microbial imbalance/small intestine bacterial overgrowth (SIBO)
the acid suppression group; Patients who are non-AIG and need long-term acid inhibitor (PPI more than 8 weeks or P-CAB more than 4 weeks) due to gastroesophageal reflux and other reasons	Diagnostic test: hydrogen and methane breath testing; The hydrogen and methane breath testingt(HMBT) is a non-invasive method based on gas analysis of gut microbiota metabolomics.Normal human metabolic processes do not produce methane and hydrogen, and all methane and hydrogen in exhaled breath come from metabolites produced during the fermentation of substrates by gut microbiota. About 14-21% of the gas can diffuse through the intestinal mucosa to the bloodstream, circulate through the bloodstream to the alveoli, and be exhaled through gas exchange.Based on substrate properties, separate and measure methane and hydrogen concentrations from exhaled breath for non-invasive, convenient, and accurate diagnosis of microbial imbalance/small intestine bacterial overgrowth (SIBO)
the control group; Patients with a 1-year history of gastroscopy, with no degree of microscopic atrophy, or with mild gastric mucosal atrophy (C-I and C-II according to the Kimura-Takemoto classification) and at least 2 weeks without taking PPI/P-CAB	Diagnostic test: hydrogen and methane breath testing; The hydrogen and methane breath testingt(HMBT) is a non-invasive method based on gas analysis of gut microbiota metabolomics.Normal human metabolic processes do not produce methane and hydrogen, and all methane and hydrogen in exhaled breath come from metabolites produced during the fermentation of substrates by gut microbiota. About 14-21% of the gas can diffuse through the intestinal mucosa to the bloodstream, circulate through the bloodstream to the alveoli, and be exhaled through gas exchange.Based on substrate properties, separate and measure methane and hydrogen concentrations from exhaled breath for non-invasive, convenient, and accurate diagnosis of microbial imbalance/small intestine bacterial overgrowth (SIBO)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
hydrogen and methane breath testing	1 year

Collaborators and Investigators

• Sponsor: RenJi Hospital

Study record dates

Study Major Dates

• Study Start (Actual): January 6, 2025
• Primary Completion (Estimated): December 31, 2025
• Study Completion (Estimated): June 30, 2026

Study Registration Dates

• First Submitted: April 19, 2025
• First Submitted That Met QC Criteria: April 19, 2025
• First Posted (Actual): April 27, 2025

Study Record Updates

• Last Update Posted (Actual): April 27, 2025
• Last Update Submitted That Met QC Criteria: April 19, 2025
• Last Verified: April 1, 2025

More Information

Terms related to this study

• Keywords: small intestinal bacterial overgrowth(SIBO); hydrogen and methane breath testing(HMBT)
• Additional Relevant MeSH Terms: Digestive System Diseases; Gastrointestinal Diseases; Stomach Diseases; Gastroenteritis; Gastritis
• Other Study ID Numbers: LY2024-318-A

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No