Measurement and Analysis of Gas Composition in Digestive Tract

Sponsor
Xiuli Zuo (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT05810805
Collaborator
(none)
460
1
11
41.7

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Other: gas component of digestive tract

Study Design

Study Type:
Observational
Anticipated Enrollment :
460 participants
Observational Model:
Other
Time Perspective:
Prospective
Official Title:
Measurement and Analysis of Gas Composition in Digestive Tract: a Prospective, Single-center Observational Study
Anticipated Study Start Date :
Apr 1, 2023
Anticipated Primary Completion Date :
Aug 31, 2023
Anticipated Study Completion Date :
Mar 2, 2024

Arms and Interventions

Arm 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.

Outcome Measures

Primary Outcome Measures

  1. 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

  1. 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

  2. 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.

  3. 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.

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 70 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Qilu Hospital, Shandong University Jinan Shandong China 250012

Sponsors and Collaborators

  • Xiuli Zuo

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Xiuli Zuo, director of Qilu Hospital gastroenterology department, Shandong University
ClinicalTrials.gov Identifier:
NCT05810805
Other Study ID Numbers:
  • 2023SDU-QILU-G001
First Posted:
Apr 12, 2023
Last Update Posted:
Apr 12, 2023
Last Verified:
Mar 1, 2023
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Apr 12, 2023