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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). | Clinical Trials | Clareo Health

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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).

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).

NCT06946706•RenJi Hospital

View on ClinicalTrials.gov

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.

Eligibility

Age

18 - 65 years

Sex

ALL

Healthy Volunteers

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 more criteria

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.

Locations (1)

Shanghai Institute of Digestive Disease

Shanghai, Shanghai Municipality, China

Key Dates

Start Date

January 6, 2025

Primary Completion Date

December 31, 2025

Completion Date

June 30, 2026

Last Updated

April 27, 2025

Enrollment

220

ESTIMATED participants

Conditions

Autoimmune Gastritis

Interventions

hydrogen and methane breath testing

DIAGNOSTIC_TEST

Contacts

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

CONTACT

+86-02158729363 Yingxuanchen71@126.com

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: April 27, 2025Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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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).

Inclusion Criteria

Exclusion Criteria

Safety and Efficacy Study of Betaine Hydrochloride in Treating Hypergastrinemia in Patients With Autoimmune Gastritis

UC Davis Cohort of Pre-Malignant and Malignant Gastro-Intestinal DisEases Study

Clinical Characteristics, Lifestyle and Multi-omics Analysis in Autoimmune Gastritis