NCT03675100

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
100

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jun 2009

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2009

Completed
9.3 years until next milestone

First Submitted

Initial submission to the registry

September 11, 2018

Completed
7 days until next milestone

First Posted

Study publicly available on registry

September 18, 2018

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2019

Completed
Last Updated

March 24, 2020

Status Verified

March 1, 2020

Enrollment Period

10.5 years

First QC Date

September 11, 2018

Last Update Submit

March 21, 2020

Conditions

Irritable Bowel SyndromeTight Junction AlterationPathophysiology

Keywords

Irritable bowel syndromeSubtypeTight junctionSex

Outcome Measures

Primary Outcomes (1)

  • NGF, GDNF, and TRPV-1 mRNA expression of colonic mucosa

    real-time qPCR

    up to 24 weeks

Secondary Outcomes (2)

  • ZO-1, Occludin, and Claudin mRNA expression of colonic mucosa

    up to 24 weeks

  • IL-8, TNF-a, and IL-1b mRNA expression of colonic mucosa

    up to 24 weeks

Study Arms (2)

IBS group

SHAM COMPARATOR

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

Procedure: colonoscopic mucosal biopsy

Control group

ACTIVE COMPARATOR

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

Procedure: colonoscopic mucosal biopsy

Interventions

colonoscopic mucosal biopsyPROCEDURE

colonoscopic mucosal biopsy was undertaken for every participant

Control groupIBS group

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • history of IBD
  • abdominal operation
  • severe systemic disease
  • malignancy,

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Seoul National University Bundang Hospital

Seongnam-si, Gyeonggi-do, 463-707, South Korea

Location

MeSH Terms

Conditions

Irritable Bowel SyndromeCoitus

Condition Hierarchy (Ancestors)

Colonic Diseases, FunctionalColonic DiseasesIntestinal DiseasesGastrointestinal DiseasesDigestive System DiseasesSexual BehaviorBehavior

Study Officials

  • Nayoung Kim, Professor

    Seoul National University Bundang Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

September 11, 2018

First Posted

September 18, 2018

Study Start

June 1, 2009

Primary Completion

December 1, 2019

Study Completion

December 1, 2019

Last Updated

March 24, 2020

Record last verified: 2020-03

Data Sharing

IPD Sharing
Will not share

Locations

KR(1)