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NCT03179865 Clinical Trial

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

Ulcerative Colitis Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT03179865
Other study ID # 0114-16-WOMC
Secondary ID
Status Completed
Phase
First received
Last updated
Start date January 2016
Est. completion date November 2020

Study information
Verified date November 2020
Source Wolfson Medical Center
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.

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.

Recruitment information / eligibility
Status Completed
Enrollment 28
Est. completion date November 2020
Est. primary completion date October 2020
Accepts healthy volunteers No
Gender All
Age group 4 Years to 19 Years
Eligibility 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 - -

Study Design

Related Conditions & MeSH terms

Locations
Country Name City State
Israel The Wolfson Medical Center Holon

Sponsors (1)
Lead Sponsor Collaborator
Wolfson Medical Center

Country where clinical trial is conducted

Israel, 

Outcome
Type Measure Description Time frame Safety issue
Primary 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
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