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Predictive Factors of Endoscopic Mucosal Healing in Quiescent Ulcerative Colitis (PINQLE)

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ClinicalTrials.gov Identifier: NCT02640391
Recruitment Status : Recruiting
First Posted : December 29, 2015
Last Update Posted : July 20, 2018
Sponsor:
Information provided by (Responsible Party):
Eun Soo Kim, MD, PhD, Kyungpook National University

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).

Condition or disease Intervention/treatment
Ulcerative Colitis Other: colonoscopy

Study Type : Observational
Estimated Enrollment : 150 participants
Observational Model: Case-Only
Time Perspective: Cross-Sectional
Official Title: Predictive Factors of Endoscopic Mucosal Healing in Quiescent Ulcerative Colitis: Prospective Observational Multicenter Study
Study Start Date : January 2016
Estimated Primary Completion Date : December 2018
Estimated Study Completion Date : December 2018

Resource links provided by the National Library of Medicine


Group/Cohort Intervention/treatment
Quiescent UC
Patients with quiscent UC who will undergo colonoscopy for surveillance or mucosal healing check up
Other: colonoscopy
Other Names:
  • fecal calprotectin
  • fecal immunochemical test
  • Rome III criteria for IBS




Primary Outcome Measures :
  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 Outcome Measures :
  1. Rome III criteria for IBS [ Time Frame: 1 week ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   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
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02640391


Contacts
Contact: Eun Soo Kim, MD. PhD +82-53-250-7088 dandy813@hanmail.net

Locations
Korea, Republic of
Keimyung University Dongsan Medical Center Recruiting
Daegu, Korea, Republic of, 700-712
Contact: Eun Soo Kim, MD, PhD       dandy813@hanmail.net   
Principal Investigator: Eun Soo Kim, MD, PhD         
Sponsors and Collaborators
Kyungpook National University
Investigators
Principal Investigator: Eun Soo Kim, MD, PhD Keimyung University School of Medicine

Responsible Party: Eun Soo Kim, MD, PhD, Professor, Kyungpook National University
ClinicalTrials.gov Identifier: NCT02640391     History of Changes
Other Study ID Numbers: KMU-151215
First Posted: December 29, 2015    Key Record Dates
Last Update Posted: July 20, 2018
Last Verified: July 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Keywords provided by Eun Soo Kim, MD, PhD, Kyungpook National University:
Ulcerative colitis
fecal calprotectin
mucosal healing

Additional relevant MeSH terms:
Colitis
Ulcer
Colitis, Ulcerative
Gastroenteritis
Gastrointestinal Diseases
Digestive System Diseases
Colonic Diseases
Intestinal Diseases
Pathologic Processes
Inflammatory Bowel Diseases