NCT05810805

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
460

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Apr 2023

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 13, 2023

Completed
2 months until next milestone

Study Start

First participant enrolled

April 1, 2023

Completed
11 days until next milestone

First Posted

Study publicly available on registry

April 12, 2023

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 31, 2023

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 2, 2024

Completed
Last Updated

April 12, 2023

Status Verified

March 1, 2023

Enrollment Period

5 months

First QC Date

February 13, 2023

Last Update Submit

March 31, 2023

Conditions

Inflammatory Bowel DiseasesIrritable Bowel SyndromeFunctional DyspepsiaColorectal NeoplasmsHelicobacter Pylori Infection

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (3)

  • Correlation between 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.

    Immediately after the procedure

  • The correlation between the severity of gastrointestinal symptoms and gas concentrations in various parts of the digestive tract.

    Immediately after the procedure

Study Arms (6)

Control group

Other: gas component of digestive tract

Imflammtory bowel disease group

Other: gas component of digestive tract

Irritable bowel syndrome group

Other: gas component of digestive tract

Colorectal neoplasms group

Other: gas component of digestive tract

Helicobacter pylori infection group

Other: gas component of digestive tract

functional dyspepia group

Other: gas component of digestive tract

Interventions

gas component of digestive tractOTHER

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 groupControl groupHelicobacter pylori infection groupImflammtory bowel disease groupIrritable bowel syndrome groupfunctional dyspepia group

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients undergoing endoscopy at Qilu Hospital of Shandong University

You may qualify if:

  • Patients aged 18 to 70 years.
  • Patients undergoing endoscopic examination

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Qilu Hospital, Shandong University

Jinan, Shandong, 250012, China

Location

MeSH Terms

Conditions

Inflammatory Bowel DiseasesIrritable Bowel SyndromeColorectal Neoplasms

Condition Hierarchy (Ancestors)

GastroenteritisGastrointestinal DiseasesDigestive System DiseasesIntestinal DiseasesColonic Diseases, FunctionalColonic DiseasesIntestinal NeoplasmsGastrointestinal NeoplasmsDigestive System NeoplasmsNeoplasms by SiteNeoplasmsRectal Diseases

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
director of Qilu Hospital gastroenterology department

Study Record Dates

First Submitted

February 13, 2023

First Posted

April 12, 2023

Study Start

April 1, 2023

Primary Completion

August 31, 2023

Study Completion

March 2, 2024

Last Updated

April 12, 2023

Record last verified: 2023-03

Locations

CN(1)