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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

28 participants

Study Classification

OBSERVATIONAL

Study Start Date

2016-01-31

Study Completion Date

2020-11-30

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Ulcerative Colitis

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

CROSS_SECTIONAL

Eligibility Criteria

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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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Minimum Eligible Age

4 Years

Maximum Eligible Age

19 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Responsible Party

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Prof. Arie Levine

Director, Pediatric Gastroenterology and Nutrition unit

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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The Wolfson Medical Center

Holon, , Israel

Site Status

Countries

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Israel

Other Identifiers

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0114-16-WOMC

Identifier Type: -

Identifier Source: org_study_id