Neurotrophic Factors, Tight Junction Proteins, and Cytokines in IBS

March 21, 2020 updated by: Nayoung Kim, Seoul National University Bundang Hospital

Expression of Neurotrophic Factors, Tight Junction Proteins, and Cytokines According to the Irritable Bowel Syndrome Subtype and Sex

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

100

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Korea, Republic of
    • Gyeonggi-do
      • Seongnam-si, Gyeonggi-do, Korea, Republic of, 463-707
        • Seoul National University Bundang Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Sham Comparator: IBS group
Patients who were diagnosed with IBS according to the ROME III criteria. Colonoscopic mucosal biopsy was undertaken for every subject.
Procedure: colonoscopic mucosal biopsy
colonoscopic mucosal biopsy was undertaken for every participant
Active Comparator: Control group
Healthy participants who have no gastrointestinal symptoms and no colonoscopic abnormality. Colonoscopic mucosal biopsy was undertaken for every subject.
Procedure: colonoscopic mucosal biopsy
colonoscopic mucosal biopsy was undertaken for every participant

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
NGF, GDNF, and TRPV-1 mRNA expression of colonic mucosa
Time Frame: up to 24 weeks
real-time qPCR
up to 24 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
ZO-1, Occludin, and Claudin mRNA expression of colonic mucosa
Time Frame: up to 24 weeks
real-time qPCR and Western blot
up to 24 weeks
IL-8, TNF-a, and IL-1b mRNA expression of colonic mucosa
Time Frame: up to 24 weeks
real-time qPCR
up to 24 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Seoul National University Bundang Hospital

Investigators

  • Principal Investigator: Nayoung Kim, Professor, Seoul National University Bundang Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 1, 2009

Primary Completion (Actual)

December 1, 2019

Study Completion (Actual)

December 1, 2019

Study Registration Dates

First Submitted

September 11, 2018

First Submitted That Met QC Criteria

September 15, 2018

First Posted (Actual)

September 18, 2018

Study Record Updates

Last Update Posted (Actual)

March 24, 2020

Last Update Submitted That Met QC Criteria

March 21, 2020

Last Verified

March 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • B-1305/202-003

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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