Evaluation of Early Mucosal Healing During Clinical Remission in Pediatric Ulcerative Colitis

Evaluation of PUCAI Score at Assessment for Mucosal Healing During Clinical Remission in Pediatric Ulcerative Colitis

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.

Study Overview

• Status: Completed
• Conditions: Ulcerative Colitis

Detailed Description

All pediatric patients ≤ 19 years old and at the Wolfson Medical Center pediatric IBD center who enter clinical remission are routinely assessed by colposcopy or sigmoidoscopy assess. This is an analysis of prospectively collected data regarding PUCAI and endoscopic Mayo score at the time of assessment of mucosal healing by endoscopy. Patients could be included if they have establish ulcerative colitis, while they are on remission for at least 3 months after treatment of flare. For this study, complete clinical remission was absence of abdominal pain, and no diarrhea or bleeding (PUCAI<10). sigmoidoscopy will be performed between 12-24 weeks after remission was documented.

• Study Type: Observational
• Enrollment (Actual): 28

Contacts and Locations

Study Locations

• Israel
  • Holon, Israel
    • The Wolfson Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 4 years to 19 years (ADULT, CHILD)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

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

Description

Inclusion Criteria:

1. Ulcerative Colitis patient
2. clinical remission (PUCAI<10) for at least 3 months.

3. Sigmoidoscopy for assessment mucusa healing after therapy performed between 12-24 weeks after remission was documented

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Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Wolfson Medical Center

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2016
• Primary Completion (Actual): October 1, 2020
• Study Completion (Actual): November 1, 2020

Study Registration Dates

• First Submitted: April 24, 2017
• First Submitted That Met QC Criteria: June 5, 2017
• First Posted (Actual): June 7, 2017

Study Record Updates

• Last Update Posted (Actual): November 3, 2020
• Last Update Submitted That Met QC Criteria: November 2, 2020
• Last Verified: November 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Pathologic Processes; Gastrointestinal Diseases; Gastroenteritis; Colonic Diseases; Intestinal Diseases; Inflammatory Bowel Diseases; Ulcer; Colitis; Colitis, Ulcerative
• Other Study ID Numbers: 0114-16-WOMC

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No