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Small Bowel Cleansing for Capsule Endoscopy in Pediatric Patients

NCT01783782 · Status: UNKNOWN · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 200

Last updated 2013-02-05

No results posted yet for this study

Summary

The primary aim of this prospective, randomized and controlled study was to evaluate the effect of five bowel preparation regimens on small-bowel cleansing in a pediatric population. The secondary endpoints were to evaluate the safety and the effects of preparation on diagnostic yield of CE.

Conditions

  • Capsule Endoscopy

Interventions

BEHAVIORAL

DIET

clear liquid diet for 12 hours on the day before CE, followed by an overnight fast

DRUG

polyethylene glycol 4000 solution with simethicon

patients received a high volume regime consisting of a 50 mL/Kg (up to 2 Lt/die) of PEG solution the evening before the examination, followed always by an overnight fast

DRUG

simethicon

Patients received 20 mL oral simethicone (Panamir, DMG, Italy, containing 40 mg simethicone in 1mL emulsion) and 200mL water 30 minutes before capsule ingestion

Sponsors & Collaborators

  • Azienda Policlinico Umberto I

    lead OTHER

Study Design

Allocation
RANDOMIZED
Masking
SINGLE
Model
SINGLE_GROUP

Eligibility

Min Age
2 Years
Max Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2005-11-30
Primary Completion
2013-08-31
Completion
2013-09-30

Countries

  • Italy

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01783782 on ClinicalTrials.gov