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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT02512146
Other study ID # 2015SDU-QILU-G03
Secondary ID
Status Recruiting
Phase N/A
First received July 19, 2015
Last updated July 27, 2015
Start date June 2015
Est. completion date June 2016

Study information

Verified date July 2015
Source Shandong University
Contact xiuli zuo, PHD
Phone 15588818685
Email xiulizuo@gmail.com
Is FDA regulated No
Health authority China: Ministry of Health
Study type Observational

Clinical 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.


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.


Recruitment information / eligibility

Status Recruiting
Enrollment 80
Est. completion date June 2016
Est. primary completion date April 2016
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Both
Age group 18 Years to 80 Years
Eligibility Inclusion Criteria:

Patients meeting IBS Rome III criteria. Asymptomatic individuals for health surveillance or patients for follow up after polypectomy.

Exclusion Criteria:

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.

Study Design

Observational Model: Case Control, Time Perspective: Prospective


Related Conditions & MeSH terms


Intervention

Procedure:
colonoscopy
Patients will undergo colonoscopy and participants will get biopsies from the colon.

Locations

Country Name City State
China Department of Gastroenterology, Qilu Hospital, Shandong University Jinan Shandong

Sponsors (1)

Lead Sponsor Collaborator
Shandong University

Country where clinical trial is conducted

China, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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. 4 months No
Primary 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. 6 months No
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