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Neurotrophic Factors, Tight Junction Proteins, and Cytokines in IBS

Primary Purpose

Irritable Bowel Syndrome, Tight Junction Alteration, Pathophysiology

Status
Completed
Phase
Not Applicable
Locations
Korea, Republic of
Study Type
Interventional
Intervention
colonoscopic mucosal biopsy
Sponsored by
Seoul National University Bundang Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Irritable Bowel Syndrome focused on measuring Irritable bowel syndrome, Subtype, Tight junction, Sex

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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,

Sites / Locations

  • Seoul National University Bundang Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Sham Comparator

Active Comparator

Arm Label

IBS group

Control group

Arm Description

Patients who were diagnosed with IBS according to the ROME III criteria. Colonoscopic mucosal biopsy was undertaken for every subject.

Healthy participants who have no gastrointestinal symptoms and no colonoscopic abnormality. Colonoscopic mucosal biopsy was undertaken for every subject.

Outcomes

Primary Outcome Measures

NGF, GDNF, and TRPV-1 mRNA expression of colonic mucosa
real-time qPCR

Secondary Outcome Measures

ZO-1, Occludin, and Claudin mRNA expression of colonic mucosa
real-time qPCR and Western blot
IL-8, TNF-a, and IL-1b mRNA expression of colonic mucosa
real-time qPCR

Full Information

First Posted
September 11, 2018
Last Updated
March 21, 2020
Sponsor
Seoul National University Bundang Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT03675100
Brief Title
Neurotrophic Factors, Tight Junction Proteins, and Cytokines in IBS
Official Title
Expression of Neurotrophic Factors, Tight Junction Proteins, and Cytokines According to the Irritable Bowel Syndrome Subtype and Sex
Study Type
Interventional

2. Study Status

Record Verification Date
March 2020
Overall Recruitment Status
Completed
Study Start Date
June 2009 (Actual)
Primary Completion Date
December 2019 (Actual)
Study Completion Date
December 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Seoul National University Bundang Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Irritable Bowel Syndrome, Tight Junction Alteration, Pathophysiology
Keywords
Irritable bowel syndrome, Subtype, Tight junction, Sex

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
100 (Actual)

8. Arms, Groups, and Interventions

Arm Title
IBS group
Arm Type
Sham Comparator
Arm Description
Patients who were diagnosed with IBS according to the ROME III criteria. Colonoscopic mucosal biopsy was undertaken for every subject.
Arm Title
Control group
Arm Type
Active Comparator
Arm Description
Healthy participants who have no gastrointestinal symptoms and no colonoscopic abnormality. Colonoscopic mucosal biopsy was undertaken for every subject.
Intervention Type
Procedure
Intervention Name(s)
colonoscopic mucosal biopsy
Intervention Description
colonoscopic mucosal biopsy was undertaken for every participant
Primary Outcome Measure Information:
Title
NGF, GDNF, and TRPV-1 mRNA expression of colonic mucosa
Description
real-time qPCR
Time Frame
up to 24 weeks
Secondary Outcome Measure Information:
Title
ZO-1, Occludin, and Claudin mRNA expression of colonic mucosa
Description
real-time qPCR and Western blot
Time Frame
up to 24 weeks
Title
IL-8, TNF-a, and IL-1b mRNA expression of colonic mucosa
Description
real-time qPCR
Time Frame
up to 24 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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,
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Nayoung Kim, Professor
Organizational Affiliation
Seoul National University Bundang Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Seoul National University Bundang Hospital
City
Seongnam-si
State/Province
Gyeonggi-do
ZIP/Postal Code
463-707
Country
Korea, Republic of

12. IPD Sharing Statement

Plan to Share IPD
No

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Neurotrophic Factors, Tight Junction Proteins, and Cytokines in IBS

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