Functional DyspepsiaNCT01006642
Mucosal Barrier Defects in Functional Dyspepsia by Confocal Laser Endomicroscopy
An observational study of Functional Dyspepsia, run by Shandong University at 1 site in China.
Trial summary
There has been recent interest into the potential role of mucosal barrier defects in the pathophysiology of functional gastrointestinal disorders (FGIDs). There has been evidence of increased intestinal permeability in patients of IBS,and abnormal tissue resistance in NERD. Read more about this study
- Who is it for?
- Ages 18 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Functional Dyspepsia
- How many people
- 80 participants
- Where
- 1 siteChina
- Study dates
- Jul 2009to Jul 2010
- 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 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Patients with indications for upper-endoscopy in Qilu Hospital outpatient and inpatient department are the study population of this study.
Who may be able to join
- patients meeting IBS diagnosis criteria and indications for endoscopy investigation.
- Asymptomatic individuals for health surveillance or patients for follow up after polypectomy.
Who cannot join
- Esophageal, gastric or duodenal cancer or other malignancy
- History of esophagus, stomach, or duodenum surgery
- Conditions that preclude safe biopsies (coagulopathy, haemophilia, esophageal varices,and patients on warfarin and antiplatelets)
- A history of bronchial asthma, or known allergy to fluorescein
- Pregnant or breast-feeding (for females)
- Below 18 or above 75 years of age
- Severe co-morbidities
- Unable or unwilling to give informed consent
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
Rui Ji, MD., 86-531-88396062 ext. 82169328, jirui905@gmail.com
About this study
Official title: Minimal Changes of Gastric Mucosal Barrier in the Pathophysiologic Mechanisms of Functional Dyspepsia
There has been recent interest into the potential role of mucosal barrier defects in the pathophysiology of functional gastrointestinal disorders (FGIDs). There has been evidence of increased intestinal permeability in patients of IBS,and abnormal tissue resistance in NERD. Although the mucosa of Functional dyspepsia (FD) patients is endoscopically and histologically "normal," it contains ultrastructural changes, activated immune cells, along with evidence of an increased release of mediators leading to gastric dysfunction. There is now consistent evidence indicating that mucosal barrier defects allow the passage of an increased load of bacteria, antigens and toxins which, in turn evoke activation of mucosal immune responses involved in the FD symptom.
Read the detailed description
Confocal laser endomicrosopy is a newly developed device which allows in vivo and real time observation of gastrointestinal mucosa.In our pilot study we found that the contrast agent fluorescein sodium shew differences of leakage into intercellular spaces and crypt lumen among different patients of FD.
This study is aimed to determine if there is microscopic changes detectable in the gastric mucosal epithelium through confocal endomicroscopy of FD patients, and to evaluate the relationship among minimal changes(transmission electron microscopy and Confocal laser endomicrosopy ), FD symptoms(symptom index form) , neuropeptides and immune responses(immunohistochemistry).
- Conditions
- Functional Dyspepsia
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 |
|---|---|---|
| Healthy controls | Asymptomatic individuals admitted for health surveillance or patients for follow up after polypectomy. | |
| Functional dyspepsia-EPS | Functional dyspepsia-EPS(epigastric pain syndrome) Patients admitted to outpatient department with symptoms meeting ROME III criteria | |
| Functional dyspepsia-PDS | Functional dyspepsia-PDS(postprandial distress syndrome) Patients admitted to outpatient department with symptoms meeting ROME III criteria |
What is being measured
The primary outcome is the main question the study is designed to answer.
Specific microscopic changes in the gastric mucosa as seen under the confocal endomicroscope
Measured: Within the 30 minutes after injection of fluorescein
Secondary outcomes (1)
the relationship among minimal changes, FD symptoms , neuropeptides and immune responses.
Measured: after the immunohistochemistry of biopsy
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Nov 2009 (estimated)
- Study startJul 2009
- Primary completionMar 2010 (estimated)
- Study completionJul 2010 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Functional DyspepsiaStudies 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
- 80 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
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01006642
- Sponsor's protocol ID
- 2009SDU-QILU-G04
- Status last verified
- Nov 2009
- First submitted
- 2 Nov 2009
- Last updated
- 3 Nov 2009
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 3 Nov 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Minimal Changes of Gastric Mucosal Barrier in the Pathophysiologic Mechanisms of Functional Dyspepsia
- ClinicalTrials.gov ID
- NCT01006642
- Acronym / sponsor ID
- 2009SDU-QILU-G04
- Conditions
- Functional Dyspepsia
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Shandong UniversityUniversity, hospital or other
- Study start
- Jul 2009
- Primary completion
- Mar 2010 (estimated)
- Study completion
- Jul 2010 (estimated)
- First posted
- 3 Nov 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.
There has been recent interest into the potential role of mucosal barrier defects in the pathophysiology of functional gastrointestinal disorders (FGIDs). There has been evidence of increased intestinal permeability in patients of IBS,and abnormal tissue resistance in NERD. Although the mucosa of Functional dyspepsia (FD) patients is endoscopically and histologically "normal," it contains ultrastructural changes, activated immune cells, along with evidence of an increased release of mediators leading to gastric dysfunction. There is now consistent evidence indicating that mucosal barrier defects allow the passage of an increased load of bacteria, antigens and toxins which, in turn evoke activation of mucosal immune responses involved in the FD symptom.
Detailed description
Confocal laser endomicrosopy is a newly developed device which allows in vivo and real time observation of gastrointestinal mucosa.In our pilot study we found that the contrast agent fluorescein sodium shew differences of leakage into intercellular spaces and crypt lumen among different patients of FD.
This study is aimed to determine if there is microscopic changes detectable in the gastric mucosal epithelium through confocal endomicroscopy of FD patients, and to evaluate the relationship among minimal changes(transmission electron microscopy and Confocal laser endomicrosopy ), FD symptoms(symptom index form) , neuropeptides and immune responses(immunohistochemistry).
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Healthy controls | – | –Asymptomatic individuals admitted for health surveillance or patients for follow up after polypectomy. |
| Functional dyspepsia-EPS | – | –Functional dyspepsia-EPS(epigastric pain syndrome) Patients admitted to outpatient department with symptoms meeting ROME III criteria |
| Functional dyspepsia-PDS | – | –Functional dyspepsia-PDS(postprandial distress syndrome) Patients admitted to outpatient department with symptoms meeting ROME III criteria |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with indications for upper-endoscopy in Qilu Hospital outpatient and inpatient department are the study population of this study.
Key inclusion criteria (2 listed)
- patients meeting IBS diagnosis criteria and indications for endoscopy investigation.
- Asymptomatic individuals for health surveillance or patients for follow up after polypectomy.
Key exclusion criteria (8 listed)
- Esophageal, gastric or duodenal cancer or other malignancy
- History of esophagus, stomach, or duodenum surgery
- Conditions that preclude safe biopsies (coagulopathy, haemophilia, esophageal varices,and patients on warfarin and antiplatelets)
- A history of bronchial asthma, or known allergy to fluorescein
- Pregnant or breast-feeding (for females)
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
Specific microscopic changes in the gastric mucosa as seen under the confocal endomicroscope
Time frame: Within the 30 minutes after injection of fluorescein
1 secondary outcome
the relationship among minimal changes, FD symptoms , neuropeptides and immune responses.
Time frame: after the immunohistochemistry of biopsy
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Nov 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
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 Functional Dyspepsia, 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 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 3 Nov 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, qiluliyanqign@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Specific microscopic changes in the gastric mucosa as seen under the confocal endomicroscope (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 3 Nov 2009.