Evaluating small intestinal bacterial overgrowth in autoimmune gastritis patients using breath tests

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).

This study is testing if people with autoimmune gastritis have more small intestinal bacterial overgrowth by using breath tests and comparing their results to others on acid suppression therapy and a control group.

Quick facts

• Study type: Observational
• Enrollment: 220 (estimated)
• Ages: 18 Years to 65 Years
• Sex: All
• Sponsor: RenJi Hospital (Academic / other)
• Locations: 1 site (Shanghai, Shanghai Municipality)
• Trial ID: NCT06946706 on ClinicalTrials.gov

What this trial studies

This observational study aims to assess the prevalence of small intestinal bacterial overgrowth (SIBO) in patients diagnosed with autoimmune gastritis (AIG) through hydrogen and methane breath testing. It will compare the positive rates of these breath tests among the AIG group, a group undergoing acid suppression therapy, and a control group. The study will include patients aged 18-65 who meet specific diagnostic criteria and have not taken certain medications prior to testing. The findings could provide insights into the relationship between SIBO and autoimmune gastritis.

Who should consider this trial

Good fit: Ideal candidates include adults aged 18-65 diagnosed with autoimmune gastritis or those requiring long-term acid suppression therapy.

Not a fit: Patients with inflammatory bowel disease, malignant tumors, or those who have had recent gastrointestinal surgeries may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could enhance understanding of SIBO in autoimmune gastritis, potentially leading to improved management strategies for affected patients.

How similar studies have performed: While the specific approach of this study may be novel, similar studies have indicated a potential link between SIBO and various gastrointestinal conditions, suggesting a promising area of investigation.

Eligibility criteria

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.

Where this trial is running

Shanghai, Shanghai Municipality

• Shanghai Institute of Digestive Disease — Shanghai, Shanghai Municipality, China (Recruiting)

Study contacts

• Study coordinator: Ying-xuan Chen Ying-xuan Chen, MD, Ph.D

Conditions Autoimmune Gastritis; small intestinal bacterial overgrowth; hydrogen and methane breath testing