CompletedNCT02640391PINQLEUpdated Aug 13, 2019

Predictive Factors of Endoscopic Mucosal Healing in Quiescent Ulcerative Colitis

An observational study in Ulcerative Colitis, sponsored by Kyungpook National University Hospital. Completed at 1 site in Korea, Republic of. Open to participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2019-08-13.

Sponsored by Kyungpook National University Hospital · Observational

Study type: Observational
Model: Case-only
Time perspective: Cross-sectional
Enrollment: 127
Ages: 18 Years to 80 Years
Sex: All

Study 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).

Conditions studied

Ulcerative Colitis

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Keywords

Ulcerative colitis
fecal calprotectin
mucosal healing

In context

Colitis

1,074 studies on the registry are indexed under Colitis; 133 are open to participants now.

This study's enrollment of 127 is above the median of 105 across 248 observational studies indexed under Colitis.

Browse Colitis studies →

Lead sponsor

Kyungpook National University Hospital is the lead sponsor of 76 studies on the registry; 8 are open to participants now.

Counted across the registry records on this site, refreshed daily.

Who can participate

Ages eligible: 18 Years to 80 Years
Sexes eligible: All
Accepts healthy volunteers: No
Sampling method: Non-probability sample

Study population

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

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

Exclusion Criteria:

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

Study design

Observational model: Case-only
Time perspective: Cross-sectional
Enrollment: 127 participants (actual)
Patient registry: No

Groups and cohorts

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

Interventions

Othercolonoscopy
Also known as: fecal calprotectin, fecal immunochemical test, Rome III criteria for IBS

What researchers measure

Primary outcomes

Mucosal healing
Endoscopic Mayo subscore \<1
Time frame: 1 week
Fecal calprotectin
Time frame: 1 week
Fecal immunochemical test
Time frame: 1 week

Secondary outcomes

Rome III criteria for IBS
Time frame: 1 week

Study locations

1 site

Keimyung University Dongsan Medical Center
Daegu, 700-712, Korea, Republic of

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

Updates

Tracking since Sep 25, 2026

No changes since tracking began. The registry record was last updated on Aug 13, 2019, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗

Registry details

Key details

Study ID: NCT02640391
Lead sponsor: Kyungpook National University Hospital
Responsible party: Eun Soo Kim, MD, PhD (Professor, Kyungpook National University Hospital) — Principal investigator
First posted: Dec 29, 2015
Start date: Jan 2016
Primary completion: Dec 2018
Completion: Dec 2018
Last update: Aug 13, 2019

Study contacts

Eun Soo Kim, MD, PhD

principal investigator · Keimyung University School of Medicine

Oversight

Data monitoring committee: Yes

View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Aug 2019. You cannot join it, but the record below documents what was studied.

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Discussion

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