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).

NCT ID: NCT06946706

Last Updated: 2025-04-27

Basic Information

• Recruitment Status: RECRUITING
• Total Enrollment: 220 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2025-01-06
• Study Completion Date: 2026-06-30

Brief Summary

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

Autoimmune Gastritis

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

the AIG group

Patients diagnosed with AIG: Previous gastroscopy (or) histological findings consistent with AIG, and serological tests support the diagnosis of AIG

hydrogen and methane breath testing

Intervention Type: DIAGNOSTIC_TEST

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

hydrogen and methane breath testing

Intervention Type: DIAGNOSTIC_TEST

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

hydrogen and methane breath testing

Intervention Type: DIAGNOSTIC_TEST

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)

Interventions

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)

Intervention Type: DIAGNOSTIC_TEST

Eligibility Criteria

Inclusion Criteria

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.

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.

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

RenJi Hospital

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Shanghai Institute of Digestive Disease

Shanghai, Shanghai Municipality, China

Site Status: RECRUITING

Countries

China

Central Contacts

Ying-xuan Chen Ying-xuan Chen, MD, Ph.D

Role: CONTACT

Yingxuanchen71@126.com

+86-02158729363

Facility Contacts

Ying-xuan Chen Ying-xuan Chen, MD, Ph.D

Role: primary

Yingxuanchen71@126.com

+862158729363

Other Identifiers

LY2024-318-A

Identifier Type: -

Identifier Source: org_study_id