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OpenTrials
Completed

NCT Number: NCT02640391

Predictive Factors of Endoscopic Mucosal Healing in Quiescent Ulcerative Colitis

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).

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Key information

Conditions

Ulcerative Colitis Colitis Colitis, Ulcerative Colonic Diseases Digestive System Diseases Gastroenteritis Gastrointestinal Diseases Inflammatory Bowel Diseases Intestinal Diseases

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Keimyung University Dongsan Medical Center

Daegu, 700-712, South Korea

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

colonoscopy

Other

Other names: fecal calprotectin, fecal immunochemical test, Rome III criteria for IBS

Primary outcomes

  1. Mucosal healing

    Time frame: 1 week

    Endoscopic Mayo subscore <1

  2. Fecal calprotectin

    Time frame: 1 week

  3. Fecal immunochemical test

    Time frame: 1 week

Secondary outcomes

  1. Rome III criteria for IBS

    Time frame: 1 week

Sponsors and collaborators

Lead sponsor

Kyungpook National University Hospital

Other

Registry information

Official study title

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

Acronym: PINQLE

Important dates

Study start
2016
Primary completion
2018
Study completion
2018
First posted
Dec 29, 2015
Registry last updated
Aug 13, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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