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OpenTrials
Completed

NCT Number: NCT03179865

Evaluation of Early 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.

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Key information

Conditions

Ulcerative Colitis Colitis Colitis, Ulcerative Colonic Diseases Digestive System Diseases Gastroenteritis Gastrointestinal Diseases Inflammatory Bowel Diseases Intestinal Diseases

Age range

4 year–19 year

Sex eligibility

All sexes

Study type

Observational

Primary location

The Wolfson Medical Center

Holon, Israel

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

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Treatment and study plan

Primary outcomes

  1. Mucusa healing according to the MAYO score

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

    present of endoscopic disease defined by mayo score

Sponsors and collaborators

Lead sponsor

Wolfson Medical Center

Other Gov

Registry information

Official study title

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

Important dates

Study start
2016
Primary completion
2020
Study completion
2020
First posted
Jun 7, 2017
Registry last updated
Nov 3, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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