Neurotrophic Factors, Tight Junction Proteins, and Cytokines in IBS

NCT ID: NCT03675100

Last Updated: 2020-03-24

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

100 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-06-30

Study Completion Date

2019-12-31

Brief Summary

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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

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Conditions

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Irritable Bowel Syndrome Tight Junction Alteration Pathophysiology

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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IBS group

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

Group Type SHAM_COMPARATOR

colonoscopic mucosal biopsy

Intervention Type PROCEDURE

colonoscopic mucosal biopsy was undertaken for every participant

Control group

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

Group Type ACTIVE_COMPARATOR

colonoscopic mucosal biopsy

Intervention Type PROCEDURE

colonoscopic mucosal biopsy was undertaken for every participant

Interventions

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colonoscopic mucosal biopsy

colonoscopic mucosal biopsy was undertaken for every participant

Intervention Type PROCEDURE

Eligibility Criteria

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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,
Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Seoul National University Bundang Hospital

OTHER

Sponsor Role lead

Responsible Party

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Nayoung Kim

Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Nayoung Kim, Professor

Role: PRINCIPAL_INVESTIGATOR

Seoul National University Bundang Hospital

Locations

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Seoul National University Bundang Hospital

Seongnam-si, Gyeonggi-do, South Korea

Site Status

Countries

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South Korea

Other Identifiers

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B-1305/202-003

Identifier Type: -

Identifier Source: org_study_id

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