Measurement and Analysis of Gas Composition in Digestive Tract

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

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Functional Dyspepsia; Irritable Bowel Syndrome; Colorectal Neoplasms; Inflammatory Bowel Diseases; Helicobacter Pylori Infection
• Intervention / Treatment: Other: gas component of digestive tract

• Study Type: Observational
• Enrollment (Anticipated): 460

Contacts and Locations

Study Locations

• China
  • Shandong
    • Jinan, Shandong, China, 250012
      • Qilu Hospital, Shandong University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

• Sampling Method: Non-Probability Sample

Study Population

Patients undergoing endoscopy at Qilu Hospital of Shandong University

Description

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 Plan

How is the study designed?

Number of groups / cohorts

6

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Control group	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.
Imflammtory bowel disease group	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.
Irritable bowel syndrome group	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.
Colorectal neoplasms group	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.
Helicobacter pylori infection group	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.
functional dyspepia group	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.

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Xiuli Zuo

Study record dates

Study Major Dates

• Study Start (Anticipated): April 1, 2023
• Primary Completion (Anticipated): August 31, 2023
• Study Completion (Anticipated): March 2, 2024

Study Registration Dates

• First Submitted: February 13, 2023
• First Submitted That Met QC Criteria: March 31, 2023
• First Posted (Actual): April 12, 2023

Study Record Updates

• Last Update Posted (Actual): April 12, 2023
• Last Update Submitted That Met QC Criteria: March 31, 2023
• Last Verified: March 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Neoplasms; Neoplasms by Site; Signs and Symptoms, Digestive; Gastrointestinal Neoplasms; Digestive System Neoplasms; Gastrointestinal Diseases; Gastroenteritis; Colonic Diseases, Functional; Colonic Diseases; Intestinal Diseases; Intestinal Neoplasms; Rectal Diseases; Dyspepsia; Irritable Bowel Syndrome; Colorectal Neoplasms; Inflammatory Bowel Diseases
• Other Study ID Numbers: 2023SDU-QILU-G001

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No