Irritable Bowel SyndromeNCT01632488
Assessment of Small Intestinal Bowel Epithelial Gaps in Irritable Bowel Syndrome
An observational study of Irritable Bowel Syndrome and Inflammatory Bowel Disease, run by Shandong University at 1 site in China.
Trial summary
The study aims to: 1. Determine whether the density of epithelial gaps in terminal ileum of patients with irritable bowel syndrome (IBS) is different from that in inflammatory bowel disease (IBD) patients and normal controls by confocal laser endomicroscopy (CLE). 2. Read more about this study
- Who is it for?
- Ages 18 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Irritable Bowel Syndrome, Inflammatory Bowel Disease
- How many people
- 45 participants
- Where
- 1 siteChina
- Study dates
- Jun 2012to Dec 2012
- 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 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Patients with indications for colonoscopy in Qilu Hospital outpatient and inpatient department.
Who may be able to join
- Bowel habits alterations meeting IBS Rome III criteria and indications for colonoscopy investigation
- Patients with history of inflammatory bowel disease
- Asymptomatic individuals for health surveillance or patients for follow up after polypectomy
- Patients complained of hemafecia but colonoscopy revealed only haemorrhoid
Who cannot join
- Patients with known cancers or abdominal surgery
- Alarm symptoms such as anaemia, gastrointestinal bleeding or obstruction, marked weight loss, abdominal mass
- Patients who are unwilling to sign or give the informed consent form
- Patients who are allergic to fluorescein sodium
- Patients with impaired cardiac, liver or renal function
- Patients with coagulopathy
- Patients with pregnancy or breastfeeding
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Facility: Department of Gastroenterology, Qilu Hospital, Shandong University
Jinan, Shandong, 250012
Yanqing Li, MD, PhD, 86-531-82169236 ext. 82169508, liyanqing@sdu.edu.cn
About this study
Official title: Assessment of Small Intestinal Bowel Epithelial Gaps in Patients With Irritable Bowel Syndrome by Confocal Laser Endomicroscopy
The study aims to:
- Determine whether the density of epithelial gaps in terminal ileum of patients with irritable bowel syndrome (IBS) is different from that in inflammatory bowel disease (IBD) patients and normal controls by confocal laser endomicroscopy (CLE).
- Evaluate the relationship between the density of epithelial gaps and IBS subtypes, and visceral hypersensitivity.
Read the detailed description
Epithelial cells lining the gastrointestinal tract serve as a barrier between the gut lumen and the body. Previous study has shown that epithelium is punctuated by discontinuities named "gaps". Confocal laser endomicroscopy could be used as a useful tool for detecting epithelial gaps in vivo, and epithelial gap density in terminal ileum of IBD patients was elevated compared with normal control using CLE. So this study aims to determine whether the density of epithelial gaps in terminal ileum of patients with IBS is different from that in IBD patients and normal controls by CLE, and to evaluate the relationship between the density of epithelial gaps and IBS subtypes, and visceral hypersensitivity.
- Keywords
- Irritable Bowel Syndrome, Inflammatory Bowel Disease, Confocal Laser Endomicroscopy
- Medical subject headings
- Irritable Bowel Syndrome, Inflammatory Bowel Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Irritable bowel syndrome | Patients admitted to outpatient department with symptoms meeting Rome III criteria of irritable bowel syndrome. | |
| Inflammation | Patients with long standing history or short onset of inflammatory bowel disease. | |
| Normal controls | Asymptomatic individuals admitted for health surveillance or patients for follow up after polypectomy. |
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Jul 2012 (estimated)
- Study startJun 2012
- Primary completionDec 2012 (estimated)
- Study completionDec 2012 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Irritable Bowel SyndromeStudies 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
- Case-control
- Time perspective
- Prospective
- Enrolment
- 45 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shandong University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Yanqing Li, Shandong University
- Investigators
- Yanqing Li, MD, PhD, Study director, Department of Gastroenterology, Qilu Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01632488
- Sponsor's protocol ID
- 2012SDU-QILU-G02
- Status last verified
- Jun 2012
- First submitted
- 28 Jun 2012
- Last updated
- 3 Jul 2012
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 3 Jul 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessment of Small Intestinal Bowel Epithelial Gaps in Patients With Irritable Bowel Syndrome by Confocal Laser Endomicroscopy
- ClinicalTrials.gov ID
- NCT01632488
- Acronym / sponsor ID
- 2012SDU-QILU-G02
- Keywords
- Irritable Bowel Syndrome, Inflammatory Bowel Disease, Confocal Laser Endomicroscopy
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 45 participants (estimated)
- Lead sponsor
- Shandong UniversityUniversity, hospital or other
- Study start
- Jun 2012
- Primary completion
- Dec 2012 (estimated)
- Study completion
- Dec 2012 (estimated)
- First posted
- 3 Jul 2012 (estimated)
- 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 study aims to:
- Determine whether the density of epithelial gaps in terminal ileum of patients with irritable bowel syndrome (IBS) is different from that in inflammatory bowel disease (IBD) patients and normal controls by confocal laser endomicroscopy (CLE).
- Evaluate the relationship between the density of epithelial gaps and IBS subtypes, and visceral hypersensitivity.
Detailed description
Epithelial cells lining the gastrointestinal tract serve as a barrier between the gut lumen and the body. Previous study has shown that epithelium is punctuated by discontinuities named "gaps". Confocal laser endomicroscopy could be used as a useful tool for detecting epithelial gaps in vivo, and epithelial gap density in terminal ileum of IBD patients was elevated compared with normal control using CLE. So this study aims to determine whether the density of epithelial gaps in terminal ileum of patients with IBS is different from that in IBD patients and normal controls by CLE, and to evaluate the relationship between the density of epithelial gaps and IBS subtypes, and visceral hypersensitivity.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Irritable bowel syndrome | – | –Patients admitted to outpatient department with symptoms meeting Rome III criteria of irritable bowel syndrome. |
| Inflammation | – | –Patients with long standing history or short onset of inflammatory bowel disease. |
| Normal controls | – | –Asymptomatic individuals admitted for health surveillance or patients for follow up after polypectomy. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with indications for colonoscopy in Qilu Hospital outpatient and inpatient department.
Key inclusion criteria (4 listed)
- Bowel habits alterations meeting IBS Rome III criteria and indications for colonoscopy investigation
- Patients with history of inflammatory bowel disease
- Asymptomatic individuals for health surveillance or patients for follow up after polypectomy
- Patients complained of hemafecia but colonoscopy revealed only haemorrhoid
Key exclusion criteria (7 listed)
- Patients with known cancers or abdominal surgery
- Alarm symptoms such as anaemia, gastrointestinal bleeding or obstruction, marked weight loss, abdominal mass
- Patients who are unwilling to sign or give the informed consent form
- Patients who are allergic to fluorescein sodium
- Patients with impaired cardiac, liver or renal function
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Not reported in the source record.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Jul 2012.
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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.
Yanqing Li, MD, PhD study director
Department of Gastroenterology, Qilu Hospital
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 Irritable Bowel Syndrome and Inflammatory Bowel Disease, run by Shandong University 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 4 inclusion and 7 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 3 Jul 2012. 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?
Contact Yanqing Li, MD, PhD (86-531-8216923 ext. 82169508, liyanqing@sdu.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
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 3 Jul 2012.