NCT03179865

Brief Summary

Establishing that mucosal healing (MH) has occurred after therapy is an important treatment goal, and the gold standard is endoscopic evaluation. In UC it is unclear if clinical parameters are adequate. The pediatric ulcerative colitis activity index (PUCAI) has demonstrated good correlations for clinical remission and disease severity, but its role for establishing mucosal healing after therapy has not been validated . The ability to predict mucosal healing may be different for patients in long term remission compared to assessment after obtaining clinical remission. No previous study has prospectively validated the use of PUCAI as a proxy for MH specifically during clinical remission after therapy.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
28

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Jan 2016

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2016

Completed
1.3 years until next milestone

First Submitted

Initial submission to the registry

April 24, 2017

Completed
1 month until next milestone

First Posted

Study publicly available on registry

June 7, 2017

Completed
3.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2020

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2020

Completed
Last Updated

November 3, 2020

Status Verified

November 1, 2020

Enrollment Period

4.8 years

First QC Date

April 24, 2017

Last Update Submit

November 2, 2020

Conditions

Ulcerative Colitis

Outcome Measures

Primary Outcomes (1)

  • Mucusa healing according to the MAYO score

    present of endoscopic disease defined by mayo score

    cross sectional study, the data will be reported during 4 years

Eligibility Criteria

Age4 Years - 19 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)
Sampling MethodNon-Probability Sample
Study Population

Patients could be included if they have establish ulcerative colitis, while they are on clinical remission

You may qualify if:

  • Ulcerative Colitis patient
  • clinical remission (PUCAI\<10) for at least 3 months.
  • Sigmoidoscopy for assessment mucusa healing after therapy performed between 12-24 weeks after remission was documented

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

The Wolfson Medical Center

Holon, Israel

Location

MeSH Terms

Conditions

Colitis, Ulcerative

Condition Hierarchy (Ancestors)

ColitisGastroenteritisGastrointestinal DiseasesDigestive System DiseasesInflammatory Bowel DiseasesColonic DiseasesIntestinal Diseases

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER GOV
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Director, Pediatric Gastroenterology and Nutrition unit

Study Record Dates

First Submitted

April 24, 2017

First Posted

June 7, 2017

Study Start

January 1, 2016

Primary Completion

October 1, 2020

Study Completion

November 1, 2020

Last Updated

November 3, 2020

Record last verified: 2020-11

Locations

IL(1)