A Treat-to-target Strategy Using Pan-enteric Capsule Endoscopy (PCE) in Paediatric Crohn's Disease (CD).

A Treat-to-target Strategy Using Pan-enterica Capsule Endoscopy (PCE) in Paediatric Crohn's Disease (CD).

NCT03161886•Azienda Policlinico Umberto I

Summary

This prospective, interventional study aims this to determine the efficacy and safety of a PCE-based treat-to-target strategy in order to achieve Mucosal Healing (MH) and deep remission (DR) of pediatric Crohn's Disease (CD) over 52 weeks.

Detailed Description

This first prospective study on mucosal healing (MH) and deep remission (DR) in pediatric Crohn's Disease aims to evaluate: * The ability of Pan-enteric capsule endoscopy (PCE) to assess MH and DR rates at three time points and to guide a treat-to-target strategy was the primary outcome sought. * The efficacy of a "treat-to-target" strategy to MH and DR rates over 24 and 52 weeks was evaluated as a secondary outcome; * Comparison between PCE, biomarkers, Magnetic Resonance Enterography (MRE) and Small Intestine contrast ultrasonography (SICUS) in evaluating intestinal inflammation.

Eligibility

Age

6 - 18 years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•diagnosis of Crohn's Disease made at least 3 months before the enrolment;
•subject was referred for endoscopic and imaging follow-up in Crohn's Disease
•signed informed consent.

Exclusion Criteria

•Subject has dysphagia
•Subject has renal insufficiency
•Subject is known structuring Crohn's Disease identified by magnetic resonance enterography (MRE) or small intestine contrast ultrasonography (SICUS).
•Subject has had prior abdominal surgery of the gastrointestinal tract other than uncomplicated procedures that would be unlikely to lead to bowel obstruction based on the magnetic resonance enterography findings and clinical judgment of the investigator.

Key Dates

Start Date

December 1, 2014

Primary Completion Date

December 1, 2016

Completion Date

January 10, 2017

Last Updated

January 8, 2018

Enrollment

ACTUAL participants

Conditions

Inflammatory Bowel DiseasesChildren, Only

Interventions

Pan-enteric Capsule Endoscopy (PCE)

DEVICE

A Phase 2 Study to Evaluate MORF-057 in Adults With Moderately to Severely Active Crohn's Disease

NCT06226883

Inflammatory Bowel DiseasesCrohn's Disease

View study

RECRUITING

The Impact of Sepsis on Long-term Outcomes in Critical Ill Children With Sepsis

NCT06323226

SepsisChildren, Only

View study

Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: January 8, 2018Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions

A Treat-to-target Strategy Using Pan-enteric Capsule Endoscopy (PCE) in Paediatric Crohn's Disease (CD).

Inclusion Criteria

Exclusion Criteria

A Phase 2 Study to Evaluate MORF-057 in Adults With Moderately to Severely Active Crohn's Disease

The Impact of Sepsis on Long-term Outcomes in Critical Ill Children With Sepsis

Institutional Registry of Rare Diseases

Robotic Inflammatory Bowel Disease Development, Learning and Efficacy Study

Feasibility of a Wireless Thermal Capsule Endoscopy to Detect Gastrointestinal Thermal Variance

Clinnova-IBD, a Prospective Cohort of Patients With Inflammatory Bowel Disease (IBD)