Measurement and Analysis of Gas Composition in Digestive Tract

Not yet recruiting

• Conditions: Helicobacter Pylori Infection; Inflammatory Bowel Diseases; Functional Dyspepsia; Irritable Bowel Syndrome; Colorectal Neoplasms
• Interventions: Other: gas component of digestive tract

• Registration Number: NCT05810805
• Lead Sponsor: Xiuli Zuo

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2023-02-13
• Status Verified: 2023-03
• Study First Submitted QC: 2023-03-31
• Last Update Submitted: 2023-03-31
• Study Start: 2023-04-01
• Study First Posted: 2023-04-12
• Last Update Posted: 2023-04-12
• Primary Completion: 2023-08-31
• Study Completion: 2024-03-02

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 460

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
functional dyspepia group	gas component of digestive tract	-
Imflammtory bowel disease group	gas component of digestive tract	-
Helicobacter pylori infection group	gas component of digestive tract	-
Control group	gas component of digestive tract	-
Colorectal neoplasms group	gas component of digestive tract	-
Irritable bowel syndrome group	gas component of digestive tract	-

Primary Outcome Measures

Name	Time	Method
Concentrations of different gas in digestive tract	immediately after the procedure	Concentrations of H2, CH4, NO and H2S in various parts of digestive tract

Secondary Outcome Measures

Name	Time	Method
Correlation between digestive tract and breath test	Immediately after the procedure	Correlation between concentration levels of H2, CH4, NO and H2S in various parts of digestive tract and breath test
The correlation between the severity of gastrointestinal symptoms and gas concentrations in various parts of the digestive tract.	Immediately after the procedure	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.
Differences in concentrations of H2, CH4, NO, and H2S in the digestive tract between patients with different gastrointestinal diseases and normal individuals.	Immediately after the procedure	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.

Trial Locations

Locations (1)

Qilu Hospital, Shandong University; 🇨🇳 Jinan, Shandong, China