NCT02640391

Brief Summary

The purpose of this study is to determine whether fecal calprotectin, fecal immunochemical test, and Rome III criteria for irritable bowel syndrome (IBS) can predict mucosal healing in patients with quiescent ulcerative colitis (UC).

Trial Health

87
On Track

Trial Health Score

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

Enrollment
127

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jan 2016

Typical duration for all trials

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

First Submitted

Initial submission to the registry

December 15, 2015

Completed
14 days until next milestone

First Posted

Study publicly available on registry

December 29, 2015

Completed
3 days until next milestone

Study Start

First participant enrolled

January 1, 2016

Completed
2.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2018

Completed
Last Updated

August 13, 2019

Status Verified

August 1, 2019

Enrollment Period

2.9 years

First QC Date

December 15, 2015

Last Update Submit

August 12, 2019

Conditions

Ulcerative Colitis

Keywords

Ulcerative colitisfecal calprotectinmucosal healing

Outcome Measures

Primary Outcomes (3)

  • Mucosal healing

    Endoscopic Mayo subscore \<1

    1 week

  • Fecal calprotectin

    1 week

  • Fecal immunochemical test

    1 week

Secondary Outcomes (1)

  • Rome III criteria for IBS

    1 week

Study Arms (1)

Quiescent UC

Patients with quiscent UC who will undergo colonoscopy for surveillance or mucosal healing check up

Other: colonoscopy

Interventions

colonoscopyOTHER
Also known as: fecal calprotectin, fecal immunochemical test, Rome III criteria for IBS
Quiescent UC

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients with inactive UC (Mayo score \<3) who are scheduled to undergo colonoscopy for surveillance or mucosal healing check-up

You may qualify if:

  • Patients with ulcerative colitis who have no change of medication for at least 6 months
  • Patients with ulcerative colitis who are in remission (Mayo score \<3)
  • Patients with ulcerative colitis who will undergo colonoscopy for surveillance or mucosal healing check-up

You may not qualify if:

  • Patients who refuse to participate
  • Patients who have a history of colectomy
  • Patients who have instinal stricture or perforation

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Keimyung University Dongsan Medical Center

Daegu, 700-712, South Korea

Location

MeSH Terms

Conditions

Colitis, Ulcerative

Interventions

Colonoscopy

Condition Hierarchy (Ancestors)

ColitisGastroenteritisGastrointestinal DiseasesDigestive System DiseasesInflammatory Bowel DiseasesColonic DiseasesIntestinal Diseases

Intervention Hierarchy (Ancestors)

Endoscopy, GastrointestinalEndoscopy, Digestive SystemDiagnostic Techniques, Digestive SystemDiagnostic Techniques and ProceduresDiagnosisEndoscopyDiagnostic Techniques, SurgicalDigestive System Surgical ProceduresSurgical Procedures, OperativeMinimally Invasive Surgical Procedures

Study Officials

  • Eun Soo Kim, MD, PhD

    Keimyung University School of Medicine

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

December 15, 2015

First Posted

December 29, 2015

Study Start

January 1, 2016

Primary Completion

December 1, 2018

Study Completion

December 1, 2018

Last Updated

August 13, 2019

Record last verified: 2019-08

Data Sharing

IPD Sharing
Will not share

Locations

KR(1)