Measurement and Analysis of Gas Composition in Digestive Tract

Study Overview
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Brief Summary
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The purpose of this study is to detect the concentration of various gases，including hydrogen, methane, hydrogen sulfide, nitric oxide in different parts of the digestive tract by a safe and direct method, and to establish a human digestive tract gas profiles. Analyze the differences in gas components in different segments of the digestive tract in patients with different diseases, and analyze the correlation between specific gases and digestive tract diseases and non-specific symptoms.

Official Title
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Measurement and Analysis of Gas Composition in Digestive Tract: a Prospective, Single-center Observational Study

Conditions
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Inflammatory Bowel Diseases, Irritable Bowel Syndrome, Functional Dyspepsia, Colorectal Neoplasms, Helicobacter Pylori Infection

Intervention / Treatment
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* Other: gas component of digestive tract


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients aged 18 to 70 years. Patients undergoing endoscopic examination Exclusion Criteria: Patients with serious underlying diseases, such as liver insufficiency, renal insufficiency, immunosuppression, coronary heart disease (angina pectoris or coronary artery stenosis ≥ 75%). Patients have history of gastrointestinal surgery Patients who failed to complete the endoscopic examination due to various reasons Patients Boston score of Bowel preparation≤ 6 points Patients who have medication history of probiotics, antibiotics, PPIs and prokinetic drugs in the last 4 weeks Patients who combined with thyroid disease and other diseases that affect gastrointestinal motility Patients who combined with other risk factors such as mental illness, alcoholism, and drug abuse Patients who unable or unwilling to provide informed consent

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Control group<br> | Other: gas component of digestive tract<br>* Analyze the differences in gas components in different segments of the digestive tract in patients with different diseases, and analyze the correlation between specific gases and digestive tract diseases and non-specific symptoms.<br>|
| Imflammtory bowel disease group<br> | Other: gas component of digestive tract<br>* Analyze the differences in gas components in different segments of the digestive tract in patients with different diseases, and analyze the correlation between specific gases and digestive tract diseases and non-specific symptoms.<br>|
| Irritable bowel syndrome group<br> | Other: gas component of digestive tract<br>* Analyze the differences in gas components in different segments of the digestive tract in patients with different diseases, and analyze the correlation between specific gases and digestive tract diseases and non-specific symptoms.<br>|
| Colorectal neoplasms group<br> | Other: gas component of digestive tract<br>* Analyze the differences in gas components in different segments of the digestive tract in patients with different diseases, and analyze the correlation between specific gases and digestive tract diseases and non-specific symptoms.<br>|
| Helicobacter pylori infection group<br> | Other: gas component of digestive tract<br>* Analyze the differences in gas components in different segments of the digestive tract in patients with different diseases, and analyze the correlation between specific gases and digestive tract diseases and non-specific symptoms.<br>|
| functional dyspepia group<br> | Other: gas component of digestive tract<br>* Analyze the differences in gas components in different segments of the digestive tract in patients with different diseases, and analyze the correlation between specific gases and digestive tract diseases and non-specific symptoms.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Concentrations of different gas in digestive tract | Concentrations of H2, CH4, NO and H2S in various parts of digestive tract | immediately after the procedure | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Correlation between digestive tract and breath test | Correlation between concentration levels of H2, CH4, NO and H2S in various parts of digestive tract and breath test | Immediately after the procedure | 
| Differences in concentrations of H2, CH4, NO, and H2S in the digestive tract between patients with different gastrointestinal diseases and normal individuals. | The diagnosis of imflammtory bowel disease, irritable bowel syndrome, colorectal neoplasms, helicobacter pylori infection and functional dyspepia refer to Chinese guidelines or expert consensus. The gas sample will be taken through the biopsy port during endoscopy. The concentration of H2, CH4, NO and H2S will be assessed by chemical gas sensor. The measured concentration of H2 and CH4 is one part per million(ppm). For NO and H2S, the measured concentration is one part per billion (ppb). For different disease groups, the difference between the control groups and the disease group will be analyzed with Student's t test or Mann-Whitney U test. | Immediately after the procedure | 
| The correlation between the severity of gastrointestinal symptoms and gas concentrations in various parts of the digestive tract. | The symptoms will be assessed by Gastrointestinal Symptom-Rating Scale (GSRS) scores. The gas sample will be taken through the biopsy port during endoscopy. The concentration of H2, CH4, NO and H2S will be assessed by chemical gas sensor. The measured concentration of H2 and CH4 is one part per million(ppm). For NO and H2S, the measured concentration is one part per billion (ppb). The Spearman correlation will be used to determine the correlation between the severity of gastrointestinal symptoms and different gas concentration. | Immediately after the procedure |