Measurement and Analysis of Gas Composition in Digestive Tract

Inflammatory Bowel Diseases Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05810805
• Other study ID #: 2023SDU-QILU-G001
• Status: Not yet recruiting
• Start date: April 1, 2023
• Est. completion date: March 2, 2024

Study information

• Verified date: March 2023
• Source: Shandong University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 460
• Est. completion date: March 2, 2024
• Est. primary completion date: August 31, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

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

Related Conditions & MeSH terms

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

Intervention

Other:
• gas component of digestive tract
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.

Locations

Country	Name	City	State
China	Qilu Hospital, Shandong University	Jinan	Shandong

Sponsors (1)

Lead Sponsor	Collaborator
Xiuli Zuo

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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