Ulcerative ColitisPINQLENCT02640391
Predictive Factors of Endoscopic Mucosal Healing in Quiescent Ulcerative Colitis
An observational study of Ulcerative Colitis, run by Kyungpook National University Hospital at 1 site in South Korea.
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). Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Ulcerative Colitis
- What is being tested?
- colonoscopy
- How many people
- 127 participants
- Where
- 1 siteSouth Korea
- Study dates
- Jan 2016to Dec 2018
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients with inactive UC (Mayo score <3) who are scheduled to undergo colonoscopy for surveillance or mucosal healing check-up
Who may be able to join
- 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
Who cannot join
- Patients who refuse to participate
- Patients who have a history of colectomy
- Patients who have instinal stricture or perforation
Trial locations and contacts
1 site in 1 country.
South Korea1 site
Keimyung University Dongsan Medical Center
Daegu, 700-712
About this study
Official title: Predictive Factors of Endoscopic Mucosal Healing in Quiescent Ulcerative Colitis: Prospective Observational Multicenter Study
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
- Ulcerative Colitis
- Being tested
- colonoscopy
- Keywords
- Ulcerative colitis, fecal calprotectin, mucosal healing
- Medical subject headings
- Colitis, Ulcerative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
colonoscopyOther
Also called fecal calprotectin, fecal immunochemical test, Rome III criteria for IBS
| Study group | Role | What they receive |
|---|---|---|
| Quiescent UC | Patients with quiscent UC who will undergo colonoscopy for surveillance or mucosal healing check up Receives: Other: colonoscopy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mucosal healing
Endoscopic Mayo subscore <1
Measured: 1 week
Fecal calprotectin
Measured: 1 week
Fecal immunochemical test
Measured: 1 week
Secondary outcomes (1)
Rome III criteria for IBS
Measured: 1 week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Dec 2015 (estimated)
- Study startJan 2016
- Primary completionDec 2018
- Study completionDec 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ulcerative ColitisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Cross-sectional
- Enrolment
- 127 participants (actual)
Sponsor and investigators
- Lead sponsor
- Kyungpook National University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Eun Soo Kim, MD, PhD, Kyungpook National University Hospital
- Investigators
- Eun Soo Kim, MD, PhD, Principal investigator, Keimyung University School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02640391
- Sponsor's protocol ID
- KMU-151215
- Acronym
- PINQLE
- Status last verified
- Aug 2019
- First submitted
- 15 Dec 2015
- Last updated
- 13 Aug 2019
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Aug 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Predictive Factors of Endoscopic Mucosal Healing in Quiescent Ulcerative Colitis: Prospective Observational Multicenter Study
- ClinicalTrials.gov ID
- NCT02640391
- Acronym / sponsor ID
- PINQLE / KMU-151215
- Conditions
- Ulcerative Colitis
- Keywords
- Ulcerative colitis, fecal calprotectin, mucosal healing
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 127 participants (actual)
- Lead sponsor
- Kyungpook National University HospitalUniversity, hospital or other
- Study start
- Jan 2016
- Primary completion
- Dec 2018 (actual)
- Study completion
- Dec 2018 (actual)
- First posted
- 29 Dec 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Observational model
- Case only
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Quiescent UC | – | Other: colonoscopyPatients with quiscent UC who will undergo colonoscopy for surveillance or mucosal healing check up |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with inactive UC (Mayo score <3) who are scheduled to undergo colonoscopy for surveillance or mucosal healing check-up
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (3 listed)
- Patients who refuse to participate
- Patients who have a history of colectomy
- Patients who have instinal stricture or perforation
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| colonoscopyAlso: fecal calprotectin, fecal immunochemical test, Rome III criteria for IBS | Other | Quiescent UC |
Primary outcome
Mucosal healing
Time frame: 1 week
Endoscopic Mayo subscore <1
Fecal calprotectin
Time frame: 1 week
Fecal immunochemical test
Time frame: 1 week
1 secondary outcome
Rome III criteria for IBS
Time frame: 1 week
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Aug 2019.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Eun Soo Kim, MD, PhD principal investigator
Keimyung University School of Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Ulcerative Colitis, run by Kyungpook National University Hospital at 1 site in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 13 Aug 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Mucosal healing (time frame: 1 week). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Aug 2019.