Neurotrophic Factors, Tight Junction Proteins, and Cytokines in IBS

Not Applicable

Completed

• Conditions: Tight Junction Alteration; Irritable Bowel Syndrome; Pathophysiology
• Interventions: Procedure: colonoscopic mucosal biopsy

• Registration Number: NCT03675100
• Lead Sponsor: Seoul National University Bundang Hospital

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2009-06
• Study First Submitted: 2018-09-11
• Study First Submitted QC: 2018-09-15
• Study First Posted: 2018-09-18
• Primary Completion: 2019-12
• Study Completion: 2019-12
• Status Verified: 2020-03
• Last Update Submitted: 2020-03-21
• Last Update Posted: 2020-03-24

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 100

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
IBS group	colonoscopic mucosal biopsy	Patients who were diagnosed with IBS according to the ROME III criteria. Colonoscopic mucosal biopsy was undertaken for every subject.
Control group	colonoscopic mucosal biopsy	Healthy participants who have no gastrointestinal symptoms and no colonoscopic abnormality. Colonoscopic mucosal biopsy was undertaken for every subject.

Primary Outcome Measures

Name	Time	Method
NGF, GDNF, and TRPV-1 mRNA expression of colonic mucosa	up to 24 weeks	real-time qPCR

Secondary Outcome Measures

Name	Time	Method
ZO-1, Occludin, and Claudin mRNA expression of colonic mucosa	up to 24 weeks	real-time qPCR and Western blot
IL-8, TNF-a, and IL-1b mRNA expression of colonic mucosa	up to 24 weeks	real-time qPCR

Trial Locations

Locations (1)

Seoul National University Bundang Hospital; 🇰🇷 Seongnam-si, Gyeonggi-do, Korea, Republic of