Irritable Bowel SyndromeNCT02512146
The Expression of the Ionotropic Glutamate Receptors in Colon of IBS
An observational study of Irritable Bowel Syndrome, run by Shandong University at 1 site in China.
Trial summary
The study aims to determine the expression of the ionotropic glutamate receptors in colon of irritable bowel syndrome (IBS) patients and evaluate the relationship between the ionotropic glutamate receptors and IBS symptoms. 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
- What is being tested?
- colonoscopy
- Type of treatment
- Surgery or procedure
- How many people
- 80 participants
- Where
- 1 siteChina
- Study dates
- Jun 2015to Jun 2016
- 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 underwent colonoscopy in Qilu Hospital outpatient and inpatient department.
Who may be able to join
- Patients meeting IBS Rome III criteria. Asymptomatic individuals for health surveillance or patients for follow up after polypectomy.
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 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
Department of Gastroenterology, Qilu Hospital, Shandong University
Jinan, Shandong, 250012
xiuli zuo, PHD, 15588818685 ext. 0531-88369277, xiulizuo@gmail.com
About this study
The study aims to determine the expression of the ionotropic glutamate receptors in colon of irritable bowel syndrome (IBS) patients and evaluate the relationship between the ionotropic glutamate receptors and IBS symptoms.
Read the detailed description
Ionotropic glutamate receptors participate in pain in nervous system. In this study,participants will examine the expression of the ionotropic glutamate receptors in colon of irritable bowel syndrome (IBS) patients and evaluate the relationship between the ionotropic glutamate receptors and IBS symptoms.
Participants may futher study the mechanism using cell experiment.
- Conditions
- Irritable Bowel Syndrome
- Being tested
- colonoscopy
- Keywords
- IBS, Ionotropic glutamate receptors
- Medical subject headings
- Irritable Bowel Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
colonoscopyProcedure or surgery
Patients will undergo colonoscopy and participants will get biopsies from the colon.
| Study group | Role | What they receive |
|---|---|---|
| Irritable bowel syndrome | Patients meeting Rome III criteria of irritable bowel syndrome. Intervention: colonoscopy. Receives: Procedure: colonoscopy | |
| Normal controls | Asymptomatic individuals for health surveillance or patients for follow up after polypectomy.
Intervention: colonoscopy. Receives: Procedure: colonoscopy |
What is being measured
The primary outcome is the main question the study is designed to answer.
the expression of the ionotropic glutamate receptors
Participants will examine the expression level of ionotropic glutamate receptors using quantitative real-time RT-PCR and western blot ,examine the distribution using immunohistochemy.
Measured: 4 months
the relationship between the ionotropic glutamate receptors and IBS symptom
Symptoms will be assessed though the severity of abdominal pain or discomfort and seizure frequency.Participants will evaluate the relationship between the expression level or the distribution of ionotropic glutamate receptors and IBS symptom. If there is a link between them, participants will study the underlying molecular mechanisms.
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jul 2015 (estimated)
- Study startJun 2015
- Primary completionApr 2016 (estimated)
- Study completionJun 2016 (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
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shandong University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Yanqing Li, Shandong University
- Investigators
- xiuli zuo, PHD, Study director, Department of Gastroenterology, Qilu Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02512146
- Sponsor's protocol ID
- 2015SDU-QILU-G03
- Status last verified
- Jul 2015
- First submitted
- 19 Jul 2015
- Last updated
- 30 Jul 2015
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 30 Jul 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Expression of the Ionotropic Glutamate Receptors in Colon of IBS
- ClinicalTrials.gov ID
- NCT02512146
- Acronym / sponsor ID
- 2015SDU-QILU-G03
- Conditions
- Irritable Bowel Syndrome
- Keywords
- IBS, Ionotropic glutamate receptors
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Shandong UniversityUniversity, hospital or other
- Study start
- Jun 2015
- Primary completion
- Apr 2016 (estimated)
- Study completion
- Jun 2016 (estimated)
- First posted
- 30 Jul 2015 (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 the expression of the ionotropic glutamate receptors in colon of irritable bowel syndrome (IBS) patients and evaluate the relationship between the ionotropic glutamate receptors and IBS symptoms.
Detailed description
Ionotropic glutamate receptors participate in pain in nervous system. In this study,participants will examine the expression of the ionotropic glutamate receptors in colon of irritable bowel syndrome (IBS) patients and evaluate the relationship between the ionotropic glutamate receptors and IBS symptoms.
Participants may futher study the mechanism using cell experiment.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Irritable bowel syndrome | – | Procedure: colonoscopyPatients meeting Rome III criteria of irritable bowel syndrome. Intervention: colonoscopy. |
| Normal controls | – | Procedure: colonoscopyAsymptomatic individuals for health surveillance or patients for follow up after polypectomy. Intervention: colonoscopy. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Patients underwent colonoscopy in Qilu Hospital outpatient and inpatient department.
Key inclusion criteria (1 listed)
- Patients meeting IBS Rome III criteria. Asymptomatic individuals for health surveillance or patients for follow up after polypectomy.
Key exclusion criteria (1 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 with impaired cardiac, liver or renal function. Patients with coagulopathy. Patients with pregnancy or breastfeeding.
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 |
|---|---|---|
| colonoscopyPatients will undergo colonoscopy and participants will get biopsies from the colon. | Procedure or surgery | Irritable bowel syndrome, Normal controls |
Primary outcome
the expression of the ionotropic glutamate receptors
Time frame: 4 months
Participants will examine the expression level of ionotropic glutamate receptors using quantitative real-time RT-PCR and western blot ,examine the distribution using immunohistochemy.
the relationship between the ionotropic glutamate receptors and IBS symptom
Time frame: 6 months
Symptoms will be assessed though the severity of abdominal pain or discomfort and seizure frequency.Participants will evaluate the relationship between the expression level or the distribution of ionotropic glutamate receptors and IBS symptom. If there is a link between them, participants will study the underlying molecular mechanisms.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Jul 2015.
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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.
xiuli zuo, 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, 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 1 inclusion and 1 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 30 Jul 2015. 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 xiuli zuo, PHD (15588818685 ext. 0531-88369277, xiulizuo@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
the expression of the ionotropic glutamate receptors (time frame: 4 months). The study lists 2 primary outcomes in all. 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 30 Jul 2015.