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).

Status: Recruiting
Location: See location...
Intervention Type: Diagnostic test
Study Type: Observational
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
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 65
View:

• Inclusion criteria for the AIG group:

∙ Age range: 18-65 years old, without gender limitation;

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

‣ 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;

‣ At least 2 weeks without taking PPI/P-CAB;

‣ Possessing the ability to independently or with the assistance of medical staff, complete hydrogen and methane breath tests and related questionnaire scoring;

‣ Capable of completing the signing of informed consent forms as required.

⁃ Age: 18-65 years old, without gender limitation;

⁃ 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;

⁃ 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);

⁃ 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;

⁃ Possessing the ability to independently or with the assistance of medical staff, complete hydrogen and methane breath tests and related questionnaire scoring;

⁃ Capable of completing the signing of informed consent forms as required.

⁃ Age: 18-65 years old, without gender limitation;

⁃ 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.

Locations
Other Locations
China
Shanghai Institute of Digestive Disease
RECRUITING
Shanghai
Contact Information
Primary
Ying-xuan Chen Ying-xuan Chen, MD, Ph.D
Yingxuanchen71@126.com
+86-02158729363
Time Frame
Start Date: 2025-01-06
Estimated Completion Date: 2026-06-30
Participants
Target number of participants: 220
Treatments
the AIG group
Patients diagnosed with AIG: Previous gastroscopy (or) histological findings consistent with AIG, and serological tests support the diagnosis of AIG
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
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
Sponsors
Leads: RenJi Hospital

This content was sourced from clinicaltrials.gov