Inflammatory Bowel DiseasesNCT05810805
Measurement and Analysis of Gas Composition in Digestive Tract
An observational study of Inflammatory Bowel Diseases and Irritable Bowel Syndrome, run by Xiuli Zuo at 1 site in China.
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. Read more about this study
- Who is it for?
- Ages 18 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Inflammatory Bowel Diseases, Irritable Bowel Syndrome, Functional Dyspepsia
- What is being tested?
- gas component of digestive tract
- How many people
- 460 participants
- Where
- 1 siteChina
- Study dates
- 1 Apr 2023to 2 Mar 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Patients undergoing endoscopy at Qilu Hospital of Shandong University
Who may be able to join
- Patients aged 18 to 70 years.
- Patients undergoing endoscopic examination
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
- Conditions
- Inflammatory Bowel Diseases, Irritable Bowel Syndrome, Functional Dyspepsia, Colorectal Neoplasms, Helicobacter Pylori Infection
- Being tested
- gas component of digestive tract
- Medical subject headings
- Inflammatory Bowel Diseases, Irritable Bowel Syndrome, Colorectal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
| Study group | Role | What they receive |
|---|---|---|
| Control group | Not described Receives: Other: gas component of digestive tract | |
| Imflammtory bowel disease group | Not described Receives: Other: gas component of digestive tract | |
| Irritable bowel syndrome group | Not described Receives: Other: gas component of digestive tract | |
| Colorectal neoplasms group | Not described Receives: Other: gas component of digestive tract | |
| Helicobacter pylori infection group | Not described Receives: Other: gas component of digestive tract | |
| functional dyspepia group | Not described Receives: Other: gas component of digestive tract |
What is being measured
The primary outcome is the main question the study is designed to answer.
Concentrations of different gas in digestive tract
Concentrations of H2, CH4, NO and H2S in various parts of digestive tract
Measured: immediately after the procedure
Secondary outcomes (3)
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
Measured: 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.
Measured: 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.
Measured: Immediately after the procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Apr 2023
- Study start1 Apr 2023 (estimated)
- Primary completion31 Aug 2023 (estimated)
- Study completion2 Mar 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Inflammatory Bowel DiseasesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 460 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Xiuli Zuo
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Xiuli Zuo, Shandong University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05810805
- Sponsor's protocol ID
- 2023SDU-QILU-G001
- Status last verified
- Mar 2023
- First submitted
- 13 Feb 2023
- Last updated
- 12 Apr 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Measurement and Analysis of Gas Composition in Digestive Tract: a Prospective, Single-center Observational Study
- ClinicalTrials.gov ID
- NCT05810805
- Acronym / sponsor ID
- 2023SDU-QILU-G001
- Conditions
- Inflammatory Bowel Diseases, Irritable Bowel Syndrome, Functional Dyspepsia, Colorectal Neoplasms, Helicobacter Pylori Infection
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 460 participants (estimated)
- Lead sponsor
- Xiuli ZuoUniversity, hospital or other
- Study start
- 1 Apr 2023 (estimated)
- Primary completion
- 31 Aug 2023 (estimated)
- Study completion
- 2 Mar 2024 (estimated)
- First posted
- 12 Apr 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Other
- Time perspective
- Prospective
- Number of arms
- 6
| Arm | Type | Receives |
|---|---|---|
| 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 |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Patients undergoing endoscopy at Qilu Hospital of Shandong University
Key inclusion criteria (2 listed)
- Patients aged 18 to 70 years.
- Patients undergoing endoscopic examination
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| gas component of digestive tractAnalyze 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. | Other | Colorectal neoplasms group, Control group, Helicobacter pylori infection group, Imflammtory bowel disease group, Irritable bowel syndrome group, functional dyspepia group |
Primary outcome
Concentrations of different gas in digestive tract
Time frame: immediately after the procedure
Concentrations of H2, CH4, NO and H2S in various parts of digestive tract
3 secondary outcomes
Correlation between digestive tract and breath test
Time frame: 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.
Time frame: Immediately after the procedure
The correlation between the severity of gastrointestinal symptoms and gas concentrations in various parts of the digestive tract.
Time frame: Immediately after the procedure
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Apr 2023.
Related trials for Inflammatory Bowel Diseases
Not yet recruitingPhase 1
An Open-label, DDI Study to Investigate the Effects of Duvakitug on the PK of Selected Cytochrome P450 Substrates
Ulcerative Colitis, Crohn's Disease
RecruitingObservational study
Longitudinal Immunophenotyping of Patients With Inflammatory Bowel Disease
Inflammatory Bowel Disease, Crohn's Disease
RecruitingObservational study
Ibd CAncer and seRious Infections in France (I-CARE 2)
IBD, Ulcerative Colitis
RecruitingObservational study
Multidimensional Dynamic Early Warning System for Neonatal Necrotizing Enterocolitis: A Multicenter Clinical Study
NEC - Necrotizing Enterocolitis
Recruiting
Effect of Mediterranean Diet in Inflammatory Bowel Disease
Inflammatory Bowel Disease
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Inflammatory Bowel Diseases and Irritable Bowel Syndrome, run by Xiuli Zuo at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 12 Apr 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Concentrations of different gas in digestive tract (time frame: immediately after the procedure). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Apr 2023.