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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03675100
Other study ID # B-1305/202-003
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date June 2009
Est. completion date December 2019

Study information

Verified date March 2020
Source Seoul National University Bundang Hospital
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

To evaluate the role of neurotrophic factors (NGF, GDNF, TRPV-1), to quantity tight junction proteins (ZO-1, occludin, claudin) and cytokines (IL-8, TNF-a, IL-1b) in the colonic mucosa of IBS patients and also clarify sex differences in the pathophysiology of IBS.


Recruitment information / eligibility

Status Completed
Enrollment 100
Est. completion date December 2019
Est. primary completion date December 2019
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years to 80 Years
Eligibility Inclusion Criteria:

- Control group Those who were between 18 and 80 years old and did not have any abnormalities in colonoscopy

- Irritable bowel syndrome group Patients who diagnosed as irritable bowel syndrome according to the ROME III criteria

Exclusion Criteria:

- history of IBD

- abdominal operation

- severe systemic disease

- malignancy,

Study Design


Intervention

Procedure:
colonoscopic mucosal biopsy
colonoscopic mucosal biopsy was undertaken for every participant

Locations

Country Name City State
Korea, Republic of Seoul National University Bundang Hospital Seongnam-si Gyeonggi-do

Sponsors (1)

Lead Sponsor Collaborator
Seoul National University Bundang Hospital

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type Measure Description Time frame Safety issue
Primary NGF, GDNF, and TRPV-1 mRNA expression of colonic mucosa real-time qPCR up to 24 weeks
Secondary ZO-1, Occludin, and Claudin mRNA expression of colonic mucosa real-time qPCR and Western blot up to 24 weeks
Secondary IL-8, TNF-a, and IL-1b mRNA expression of colonic mucosa real-time qPCR up to 24 weeks
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