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NCT02640391 Clinical Trial

Predictive Factors of Endoscopic Mucosal Healing in Quiescent Ulcerative Colitis

Ulcerative Colitis Clinical Trial

— PINQLE  

Official title:
Predictive Factors of Endoscopic Mucosal Healing in Quiescent Ulcerative Colitis: Prospective Observational Multicenter Study

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT02640391
Other study ID # KMU-151215
Secondary ID
Status Completed
Phase
First received
Last updated
Start date January 2016
Est. completion date December 2018

Study information
Verified date August 2019
Source Kyungpook National University
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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).

Recruitment information / eligibility
Status Completed
Enrollment 127
Est. completion date December 2018
Est. primary completion date December 2018
Accepts healthy volunteers No
Gender All
Age group 18 Years to 80 Years
Eligibility Inclusion Criteria:

- 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

Exclusion Criteria:

- Patients who refuse to participate

- Patients who have a history of colectomy

- Patients who have instinal stricture or perforation

Study Design

Related Conditions & MeSH terms

Intervention

Other:
• colonoscopy

Locations
Country Name City State
Korea, Republic of Keimyung University Dongsan Medical Center Daegu

Sponsors (1)
Lead Sponsor Collaborator
Kyungpook National University

Country where clinical trial is conducted

Korea, Republic of, 

Outcome
Type Measure Description Time frame Safety issue
Primary Mucosal healing Endoscopic Mayo subscore <1 1 week
Primary Fecal calprotectin 1 week
Primary Fecal immunochemical test 1 week
Secondary Rome III criteria for IBS 1 week
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