Inflammatory Bowel DiseaseNCT00883077
Assessment of Colonic Permeability by Confocal Laser Endomicroscopy
An observational study of Inflammatory Bowel Disease and Ulcerative Colitis, run by Shandong University at 1 site in China.
Trial summary
The purpose of this study is to evaluate the efficacy of confocal laser endomicroscopy in assessment of colonic permeability against conventional sugar absorption test. Read more about this study
- Who is it for?
- Ages 18 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Inflammatory Bowel Disease, Ulcerative Colitis, Irritable Bowel Syndrome
- How many people
- 30 participants
- Where
- 1 siteChina
- Study dates
- Apr 2009to Dec 2009
- 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 are the study population of this study.
Who may be able to join
- Patients with history of ulcerative colitis
- Bowel habits alterations meeting IBS diagnosis criteria and indications for colonoscopy investigation
- Asymptomatic individuals for health surveillance or patients for follow up after polypectomy
- Patients complained of hemafecia but colonoscopy revealed only haemorrhoid
Who cannot join
- Known cancers or abdominal surgery
- Scheduled for endoscopic treatment
- Alarm symptoms such as anaemia, gastrointestinal bleeding or obstruction, marked weight loss, abdominal mass
- Under conditions such as:
- ascites
- jaundice
Show all 14Show fewer
- liver cirrhosis
- impaired renal function
- coagulopathy
- fever
- pregnancy
- breastfeeding
- Inability to provide informed consent
- Known allergy to fluorescein sodium
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Department of Gastroenterology, Qilu Hospital, Shandong University
Jinan, Shandong, 250012
Yanqing Li, PhD. MD., 86-531-82169236 ext. 82169508, qiluliyanqing@gmail.com
Yanqing Li, PhD. MD.
About this study
Official title: Combined Assessment of Colonic Permeability by Real Time Confocal Laser Endomicroscopy and Sucralose Absorption Test
The purpose of this study is to evaluate the efficacy of confocal laser endomicroscopy in assessment of colonic permeability against conventional sugar absorption test.
Read the detailed description
Increased intestinal permeability has been shown significant in many gastrointestinal diseases, including inflammatory bowel disease and recently irritable bowel syndrome. The conventional test methods of permeability is sugar absorption test which is neither reliable and practical. Confocal laser endomicrosopy is a newly developed device which allows in vivo and real time observation of gastrointestinal mucosa. In our preliminary study we found that the commonly used contrast agent, fluorescein sodium shew differences of leakage into colonic crypt lumen among different patients. The fluorescein leakage might be due to abnormal colonic permeability, so we planed to compare the fluorescein leakage under confocal laser endomicroscopy with conventional sucralose absorption test.
- Keywords
- permeability, inflammatory bowel disease, confocal laser endomicroscopy, irritable bowel syndrome
- Medical subject headings
- Inflammatory Bowel Diseases, Colitis, Ulcerative, Irritable Bowel Syndrome
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 |
|---|---|---|
| Inflammation | Patients with long standing history or short onset of ulcerative colitis. | |
| Healthy controls | Asymptomatic individuals admitted for health surveillance or patients for follow up after polypectomy. | |
| Irritable bowel syndrome | Patients admitted to outpatient department with symptoms meeting ROME III criteria of irritable bowel syndrome. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Fluorescein leakage under confocal laser endomicroscopy observation of colonic mucosa.
Measured: Within the 30 minutes after injection of fluorescein
Secondary outcomes (1)
Total sucralose excretion.
Measured: Within the 24 hours after drinking of sucralose
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Apr 2009 (estimated)
- Study startApr 2009
- Primary completionNov 2009 (estimated)
- Study completionDec 2009 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Inflammatory Bowel DiseaseStudies 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
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shandong University
- Sponsor type
- University, hospital or other
- Investigators
- Yanqing Li, PhD. MD., Study director, Department of Gastroenterology, Qilu Hospital, Shandong University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00883077
- Sponsor's protocol ID
- 2009SDU-QILU-G01
- Status last verified
- Oct 2009
- First submitted
- 15 Apr 2009
- Last updated
- 14 Oct 2009
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 14 Oct 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Combined Assessment of Colonic Permeability by Real Time Confocal Laser Endomicroscopy and Sucralose Absorption Test
- ClinicalTrials.gov ID
- NCT00883077
- Acronym / sponsor ID
- 2009SDU-QILU-G01
- Keywords
- permeability, inflammatory bowel disease, confocal laser endomicroscopy, irritable bowel syndrome
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Shandong UniversityUniversity, hospital or other
- Study start
- Apr 2009
- Primary completion
- Nov 2009 (estimated)
- Study completion
- Dec 2009 (estimated)
- First posted
- 17 Apr 2009 (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 purpose of this study is to evaluate the efficacy of confocal laser endomicroscopy in assessment of colonic permeability against conventional sugar absorption test.
Detailed description
Increased intestinal permeability has been shown significant in many gastrointestinal diseases, including inflammatory bowel disease and recently irritable bowel syndrome. The conventional test methods of permeability is sugar absorption test which is neither reliable and practical. Confocal laser endomicrosopy is a newly developed device which allows in vivo and real time observation of gastrointestinal mucosa. In our preliminary study we found that the commonly used contrast agent, fluorescein sodium shew differences of leakage into colonic crypt lumen among different patients. The fluorescein leakage might be due to abnormal colonic permeability, so we planed to compare the fluorescein leakage under confocal laser endomicroscopy with conventional sucralose absorption test.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Inflammation | – | –Patients with long standing history or short onset of ulcerative colitis. |
| Healthy controls | – | –Asymptomatic individuals admitted for health surveillance or patients for follow up after polypectomy. |
| Irritable bowel syndrome | – | –Patients admitted to outpatient department with symptoms meeting ROME III criteria of irritable bowel syndrome. |
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 are the study population of this study.
Key inclusion criteria (4 listed)
- Patients with history of ulcerative colitis
- Bowel habits alterations meeting IBS diagnosis criteria and indications for colonoscopy investigation
- Asymptomatic individuals for health surveillance or patients for follow up after polypectomy
- Patients complained of hemafecia but colonoscopy revealed only haemorrhoid
Key exclusion criteria (14 listed)
- Known cancers or abdominal surgery
- Scheduled for endoscopic treatment
- Alarm symptoms such as anaemia, gastrointestinal bleeding or obstruction, marked weight loss, abdominal mass
- Under conditions such as:
- Inability to provide informed consent
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
Fluorescein leakage under confocal laser endomicroscopy observation of colonic mucosa.
Time frame: Within the 30 minutes after injection of fluorescein
1 secondary outcome
Total sucralose excretion.
Time frame: Within the 24 hours after drinking of sucralose
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Oct 2009.
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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, PhD. MD. study director
Department of Gastroenterology, Qilu Hospital, Shandong University
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 Disease and Ulcerative Colitis, 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 14 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 14 Oct 2009. 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, PhD. MD. (86-531-8216923 ext. 82169508, qiluliyanqign@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Fluorescein leakage under confocal laser endomicroscopy observation of colonic mucosa. (time frame: Within the 30 minutes after injection of fluorescein). 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 14 Oct 2009.